Search Results

Manufacturer

Date Cleared

2020-04-14

(55 days)

Product Code

JGS,CEM,CFA,CGZ,JFP

Regulation Number

862.1665

Type

Panel

Reference & Predicate Devices

k180428

Intended Use

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood.

Device Description

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Stat Profile® Prime Plus Analyzer System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it presents performance data (method comparison, imprecision) that would be evaluated against established clinical or analytical goals to demonstrate substantial equivalence. The predicate device's performance often serves as the de facto acceptance benchmark.

I will interpret the "Measurement Range" from Table 4 as an implicit acceptance criterion for the device's operational range, and the "Method Comparison Studies" and "Total Imprecision Performance" tables as reported device performance demonstrating equivalence.

Parameter	Acceptance Criteria (Measurement Range)	Reported Device Performance (Method Comparison: Slope, Intercept, r)	Reported Device Performance (Total Imprecision: Total %CV - Level 4/5/Linearity)	Reported Device Performance (Within-Run Precision: %CV)
Sodium (Na)	80-200 mmol/L	Slope: 0.9964, Intercept: 0.4488, r: 0.9949	Level 4: 0.6%, Level 5: 0.8%, Linearity: 1.2%	Samples 1-7: 0.22% - 0.67%
Potassium (K)	1.0-20.0 mmol/L	Slope: 1.0158, Intercept: -0.0678, r: 0.9993	Level 4: 2.2%, Level 5: 1.9%, Linearity: 1.5%	Samples 1-7: 0.00% - 2.66%
Chloride (Cl)	50-200 mmol/L	Slope: 0.9963, Intercept: 0.4416, r: 0.9971	Level 4: 0.6%, Level 5: 0.6%, Linearity: 0.9%	Samples 1-7: 0.00% - 0.67%
Ionized Calcium (iCa)	0.4-10.8 mg/dL	Slope: 0.9820, Intercept: 0.0239, r: 0.9871	Level 4: 2.1%, Level 5: 2.7%, Linearity: 1.9%	Samples 1-7: 0.40% - 1.13%
Ionized Magnesium (iMg)	0.24-3.65 mg/dL	Slope: 1.0020, Intercept: -0.0021, r: 0.9910	Level 4: 4.4%, Level 5: 6.5%, Linearity: 5.4%	Samples 1-7: 0.52% - 2.63%

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison Studies (Test Set):
- Sample Sizes:
  - Na: 432 samples (18 altered samples)
  - K: 435 samples (21 altered samples)
  - Cl: 434 samples (20 altered samples)
  - iCa: 434 samples (20 altered samples)
  - iMg: 426 samples (13 altered samples)
- Data Provenance: The study was a Point-of-Care (POC) study conducted at 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data provenance is described as comparing "results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer." The specimens were either quality control materials or discarded blood gas specimens.
- Retrospective or Prospective: Not explicitly stated, but the description of "comparing results obtained by trained Healthcare Professionals to results obtained by POC personnel" suggests a prospective collection or at least a controlled, concurrent comparison for the purpose of the study. It's not described as a retrospective analysis of existing patient data.
Total Imprecision Performance (Test Set):
- The estimates were obtained from different POC personnel running 3 levels of Quality Control/Linearity Materials in duplicate each day for a total of 20 runs on 3 analyzers. (Implies a substantial number of measurements, but the exact N for each measurement type is not detailed beyond "20 runs").
Within-Run Whole Blood Precision (Test Set):
- Each precision run consisted of ten (10) replicate measurements. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. This was done by a minimum of two (2) point-of-care operators at each of the three (3) POC sites, for a total of nine (9) operators.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The study compares the performance of the Stat Profile® Prime Plus Analyzer System against existing laboratory methods (referred to as "Lab" in Table 1) and its own predicate device.
For the Method Comparison Studies, the "ground truth" or reference method is the "Lab" result, which would typically be generated by a validated, high-accuracy laboratory analyzer. The document does not specify individual human experts or their qualifications for establishing this ground truth; rather, it refers to the "Lab" as the reference. For clinical laboratory devices, the "ground truth" is usually the result from a recognized reference standard method or a highly accurate laboratory instrument rather than individual expert consensus.

For the Imprecision studies, the "ground truth" is typically the measured mean of repeated measurements, and the accuracy is relative to a known value for Quality Control materials. Again, this doesn't involve human experts establishing ground truth in the way it might for imaging studies.

4. Adjudication Method for the Test Set

This type of diagnostic device (blood analyzer) does not typically involve human adjudication in the same way as, for example, image-based diagnostic systems. The method comparison studies compare the device's quantitative output to that of a reference laboratory method. No specific adjudication method like "2+1" or "3+1" is mentioned or applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic systems where human readers interpret medical images or data. The Stat Profile® Prime Plus Analyzer System is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that supports human interpretation in that manner. The study focused on demonstrating the analytical performance and equivalence of the device to a predicate and laboratory methods.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The device itself is a standalone analyzer that measures parameters and produces results. The performance studies (Method Comparison, Imprecision) evaluate the device's standalone analytical performance. Although POC personnel operate the device, the data presented (slopes, intercepts, r-values, %CV) reflects the intrinsic performance of the algorithm/hardware combination (the "device") in generating quantitative measurements, rather than human interpretation. So, yes, the performance metrics reported are for the device operating in a standalone capacity (as a measurement instrument).

7. The Type of Ground Truth Used

Method Comparison Studies: The ground truth for the method comparison studies was obtained from a reference laboratory method or a "Lab" analyzer. This implies comparison to established, presumably accurate, laboratory instrumentation with well-defined performance characteristics.
Imprecision and Within-Run Precision Studies: The ground truth for these studies relies on the known concentration values of quality control materials and the statistical analysis of repeated measurements to determine the reproducibility and variability of the device.

8. The Sample Size for the Training Set

The document does not describe the device as employing a machine learning or AI algorithm that requires a distinct "training set" in the conventional sense of AI/ML development. The device uses established "Ion-Selective Electrode (ISE)" technology and measurement algorithms. Therefore, there is no mention of a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an AI model, this question is not applicable. The measurement principles are based on known electrochemical properties rather than learned patterns from a training dataset.

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K Number

K200204

Device Name

Manufacturer

Date Cleared

2020-04-06

(69 days)

Product Code

GGZ,GHS,GKK,GKR,JPI

Regulation Number

864.7500

Type

Panel

Reference & Predicate Devices

k180186

Intended Use

The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

Device Description

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

AI/ML Overview

The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and how its performance was proven.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).

Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."

Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.

Analyte	N (samples)	Range (tested)	Slope	Intercept	r (correlation coefficient)	MDL (Min. Detection Limit)	95% Confidence Interval of Bias (Lower-Upper)	Total Imprecision (Representative Data)
Hct	417	18 - 69	0.9997	0.1315	0.9929	20-56	20-20	Level 1: Mean 61, Total %CV 0.9
Level 2: Mean 38, Total %CV 0.8
Level 3: Mean 27, Total %CV 1.6
SO2	398	30 - 100	1.0084	-0.9664	0.9982	80-90	80-80	Level 1: Mean 47.5, Total %CV 1.4
Level 2: Mean 78.0, Total %CV 0.5
Level 3: Mean 91.0, Total %CV 0.0
tHb	416	5.0 - 24.2	1.0042	-0.0058	0.9923	7-22	6.9-7.1	Level 1: Mean 19.8, Total %CV 1.0
Level 2: Mean 13.3, Total %CV 2.2
Level 3: Mean 6.6, Total %CV 2.2
O2Hb	422	7.1 - 98.4	1.0072	-0.8636	0.9983	85-90	84.6-85.1	Level 1: Mean 20.5, Total %CV 1.7
Level 2: Mean 47.1, Total %CV 0.9
Level 3: Mean 80.1, Total %CV 0.2
COHb	425	0.3 - 50.5	1.0024	-0.0013	0.9986	3-10	3.0-3.0	Level 1: Mean 29.2, Total %CV 0.7
Level 2: Mean 21.2, Total %CV 1.4
Level 3: Mean 6.2, Total %CV 1.5
MetHb	437	0.3 - 56.7	1.0040	0.0006	0.9993	5-10	5.0-5.0	Level 1: Mean 27.7, Total %CV 0.4
Level 2: Mean 18.4, Total %CV 1.2
Level 3: Mean 5.8, Total %CV 2.3
HHb	322	0.4 - 39.7	1.0123	0.0882	0.9962	6-15	6.0-6.3	Level 1: Mean 22.7, Total %CV 0.6
Level 2: Mean 13.2, Total %CV 1.2
Level 3: Mean 7.9, Total %CV 1.7

2. Sample Size and Data Provenance

Test Set Sample Size:
- Method Comparison (POC vs. Lab):
  - Hct: 417 samples
  - SO2: 398 samples
  - tHb: 416 samples
  - O2Hb: 422 samples
  - COHb: 425 samples
  - MetHb: 437 samples
  - HHb: 322 samples
- Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
- Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.

6. Standalone Performance

Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.

7. Type of Ground Truth Used

Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.

8. Sample Size for the Training Set

Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.

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K Number

K200349

Device Name

Manufacturer

Date Cleared

2020-03-13

(30 days)

Product Code

CGA,CDS,CGL,KHP

Regulation Number

862.1345

Type

Panel

Reference & Predicate Devices

k180340,K110648

Intended Use

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.

Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:
There are two options for the primary sensor card:

Primary Sensor Card 1 shall enable and report the following listed analytes: o Glu. Lactate
Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate

Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card

Auxiliary Sensor Card 1 shall enable Creatinine and BUN parameters .
. Auxiliary Sensor Card 2 shall be a "dummy" sensor card, and will not report any parameters.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.

Stat Profile Prime Plus Analyzer System .
Primary Sensor Cartridge .
Auxiliary Sensor Cartridge
Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
Stat Profile Prime Plus Calibrator Cartridge ●
Stat Profile Prime Plus External Ampuled Control .
. IFU/Labeling

AI/ML Overview

This document describes the performance of the Stat Profile Prime Plus Analyzer System for the quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. The submission specifically focuses on the modification of the device to include Point-of-Care (POC) use.

It is important to note that this document is a 510(k) summary for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving novel clinical effectiveness with large-scale comparative effectiveness studies. Therefore, not all requested sections directly apply, especially those related to AI model development (training set, human-in-the-loop, MRMC studies) common in submissions for AI/ML-based diagnostic software. This device is a point-of-care blood analyzer, not an AI diagnostic software.

Here's the breakdown of the provided information within the context of this device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a singular table for all parameters as one might find for a pass/fail threshold in an AI/ML study. Instead, performance is demonstrated through various analytical validation studies (precision, linearity, interference, detection limit) and a method comparison study to show equivalence to a predicate device and laboratory methods. The "acceptance criteria" are implicitly met if the performance data supports substantial equivalence for the intended use and accuracy compared to established methods.

For Lactate (specifically detailed in the provided text):

Performance Metric	Implicit Acceptance Criteria (based on context of equivalence)	Reported Device Performance (Lactate)
Precision/Reproducibility	Demonstrates acceptable within-run and run-to-run variability across different sample types and levels.	- Within-Run (Auto QC Cartridge Levels 4 & 5): CV% ranged from 0.00% to 0.68%.

Within-Run (Quality Control Ampules Levels 4 & 5): CV% ranged from 0.00% to 1.6%.
Within-Run (Whole Blood from Syringes, 5 samples): CV% ranged from 1.3% to 8.0%.
Run-to-Run (Auto QC Cartridge Levels 4 & 5): Total Imprecision %CV ranged from 1.4% to 3.5%.
Run-to-Run (Whole Blood, 5 samples): CV% ranged from 1.8% to 14.7%. Note: Blood #1 showed a higher CV of 13.3-14.7% across devices. |
| Linearity | Demonstrates linearity across the claimed measurement range, with a high correlation (r-value) to established methods. | - Claimed Measurement Range: 0.3 - 20.0 mmol/L.
Specimen Range Tested: 0.2 - 23.5 mmol/L.
Analyzers (PP1, PP2, PP3): r-values were 0.9983, 0.9982, and 0.9988, respectively.
Comment: Results support the claimed measurement range. |
| Specificity / Interference | Identifies substances that may interfere and quantifies the highest concentration tested that shows no significant interference. | - Dose response study performed for glycolic acid and hydroxyurea showed interference at all concentrations. (Specific concentrations not given, but the fact of interference is noted).
Table 7 lists the highest non-interfering concentrations for 23 other common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ethanol, Heparin, Ibuprofen). |
| Detection Limit (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the lower limit of the claimed measurement range. | - LoB: 0.0 mmol/L
LoD: 0.1 mmol/L
LoQ: 0.1 mmol/L.
Comment: All are below the claimed lower limit of 0.3 mmol/L. |
| Method Comparison (POC vs. Lab) | Statistical agreement between the Stat Profile Prime Plus system (operated at POC by various personnel) and laboratory reference methods (implicitly, lab instruments or methodologies used for comparison). | - Analyte: Lactate
N: 413 samples
Range: 0.5 - 16.5
Slope: 1.0181
Intercept: -0.0796
r (correlation coefficient): 0.9975
95% Confidence Interval Bias (2 mmol/L): 1.9-2.0
95% Confidence Interval Bias (6 mmol/L): 6.0-6.1 |
| Total Imprecision Performance (POC)| Demonstrates acceptable total imprecision when operated by POC personnel. | - Lactate (Level 4): Mean 1.8 mmol/L, Total SD 0.1, Total %CV 3.2%
Lactate (Level 5): Mean 6.7 mmol/L, Total SD 0.2, Total %CV 3.4%
Lactate (Linearity Level 4): Mean 16.5 mmol/L, Total SD 0.4, Total %CV 2.2% |
| Within-Run Whole Blood Precision (POC)| Demonstrates acceptable within-run precision for fresh whole blood samples in POC setting. | - Lactate (7 samples): Mean values varied (e.g., 3.30, 1.43, 2.47, 2.49, 1.24, 4.69, 11.4 mmol/L). Reported %CVs ranged from 4.08% to 6.68%. |

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in the analytical performance and method comparison studies.

Sample Sizes:
- Lactate Precision (Within-Run): 20 replicates for each level/sample type (QC, Ampules, Whole Blood) on 3 analyzers.
- Lactate Precision (Run-to-Run): QC samples: 240 samples (2 runs/day for 40 runs * 3 analyzers); Whole Blood samples: 30 samples (triplicate analyses over 10 runs * 3 analyzers).
- Linearity: 9 levels tested on 3 analyzers.
- Interference: Not explicitly stated for each substance, but dose-response performed for problematic interferents.
- Detection Limit: LoB: 5 runs on 2 analyzers; LoD: 4 runs on 2 analyzers for 5 low-level samples over 3 days (total 60 replicates per reagent lot); LoQ: 3 runs on 2 analyzers for 4 low-level samples over 3 days (total 36 replicates per reagent lot).
- Method Comparison (POC vs. Lab): For Lactate: N=413 samples.
- Total Imprecision (POC): 3 levels of QC/Linearity materials, run in duplicate each day for 20 runs on 3 analyzers.
- Within-Run Whole Blood Precision (POC): 10 replicate measurements for 7 different whole blood samples at each site, by a minimum of 2 POC operators at 3 sites (total 9 operators).
Data Provenance:
- Country of Origin: Not explicitly stated but inferred to be the United States (given the FDA submission and the company address in Waltham, Massachusetts).
- Retrospective or Prospective: The studies described (e.g., precision, linearity, method comparison) are typically prospective analytical validation studies conducted specifically for regulatory submission, using controlled conditions and fresh/altered samples collected for the purpose of the study. The POC study involved current operations ("discarded blood gas specimens" and "fresh, native and altered whole blood samples") and training of personnel for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For this type of in vitro diagnostic device (blood analyzer), "ground truth" is established by comparison to reference methods or calibrated standards rather than expert consensus on images.

Number of Experts: Not applicable in the context of expert readers for imaging or clinical diagnosis. The "experts" are the laboratory personnel operating the reference instruments and the Point-of-Care personnel who were "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized."
Qualifications of Experts:
- Laboratory Personnel: Implied to be qualified professionals operating the reference analyzers (e.g., Stat Profile pHOx Ultra Analyzer System, K110648).
- Point-of-Care Personnel: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology personnel participated from 3 POC settings (Cardiothoracic Intensive Care Unit (CTICU), Emergency Department (ED), Respiratory Therapy Lab (RT)). They are described as "trained, qualified staff."

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML diagnostic software involving subjective interpretation or multiple expert reads needing adjudication. Performance is assessed analytically against reference methods or statistical metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This type of study is primarily relevant for AI/ML-based diagnostic software where the AI assists human readers in tasks like image interpretation. This submission is for an in vitro diagnostic device that directly measures analytes in blood. The study compared the device's performance to predicate devices and laboratory methods.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device's measurement process for each analyte (e.g., impedance, amperometry) can be considered "standalone" in that it performs the measurement algorithmically, the term "standalone performance" in the context of AI/ML usually refers to the accuracy of the algorithm without any human input during the diagnostic process.

For this device, the "measurements" are the direct outputs from the instrument. Its analytical performance (precision, linearity, detection limits, interference) is evaluated intrinsically (standalone from a human operator's interpretation, though a human initiates the test). The "Method Comparison Studies" then compare these outputs to a reference method, which is the closest equivalent to a "standalone" performance assessment for an IVD, demonstrating how well the device matches established lab results.

7. The Type of Ground Truth Used

The ground truth for this device's performance validation is based on reference methods and calibrated standards.

Reference Methods: The "Method Comparison Studies" compare the Stat Profile Prime Plus Analyzer System's results (both in the lab and at POC) to those obtained from the predicate device (K180340) and/or other validated laboratory methods/instruments. For Lactate, the predicate K110648 (Stat Profile pHOx Ultra Analyzer System) was used for comparison.
Calibrated Standards: Precision, linearity, and detection limit studies utilize quality control materials, calibrators, and prepared solutions with known concentrations. The linearity study specifically states comparison to "the reference analyzer and/or the product specifications defined in the Stat Profile Prime Marketing Requirements document."

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic analyzer (hardware and embedded software for physical measurement), not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "development" of its analytical components involves traditional engineering and chemistry, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device. The physical and chemical principles of measurement (e.g., enzymatic reactions, amperometry, potentiometry) form the basis of the device's function.

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K Number

K193246

Device Name

Manufacturer

Date Cleared

2020-01-24

(60 days)

Product Code

CHL

Regulation Number

862.1120

Type

Panel

Reference & Predicate Devices

k173797,K173797

Intended Use

The Stat Profile Prime Plus Analyzer System is intended for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2) and Partial Pressure of Oxygen (pO2) in heparinized arterial and venous whole blood.

pH, pCO2 and pO2 Measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.

Device Description

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device (Nova Stat Profile pHOx Ultra Analyzer System and K173797 - Stat Profile Prime Plus Analyzer System). The performance of the proposed device is compared to the predicate device and established CLSI guidelines for method comparison and imprecision.

Criterion Type	Acceptance Criteria (Implicitly from CLSI/Substantial Equivalence)	Reported Device Performance (Stat Profile Prime Plus Analyzer)
Method Comparison (POC vs Lab)	Agreement between POC measurements and laboratory measurements for pH, pCO2, and pO2, demonstrating substantial equivalence to the predicate and clinical acceptability.	pH: N=432, Range 6.832 - 7.931, Slope 0.9930, Intercept 0.0500, r 0.9976. 95% CI of Bias: MDL (7.1-7.6) for Lower Limit (7.099, 7.595) and Upper Limit (7.102, 7.601)
pO2: N=432, Range 11.5 - 555.2, Slope 1.0109, Intercept -1.5391, r 0.9989. 95% CI of Bias: MDL (40-160) for Lower Limit (38.4, 159.7) and Upper Limit (40.6, 160.7)
pCO2: N=428, Range 14.0 - 199.2, Slope 0.9848, Intercept 0.9958, r 0.9963. 95% CI of Bias: MDL (20-75) for Lower Limit (19.6, 74.5) and Upper Limit (20.9, 75.2)
Total Imprecision	Acceptable Total SD and %CV for pH, pCO2, and pO2 across multiple levels of quality control materials and different POC personnel, according to CLSI EP5-A2T.	Level 1 (pH 7.223, pCO2 60.0 mmHg, pO2 76.5 mmHg): pH Total SD 0.008; pCO2 Total SD 3.6, %CV 5.9; pO2 Total SD 2.4, %CV 3.1
Level 2 (pH 7.428, pCO2 37.2 mmHg, pO2 112.2 mmHg): pH Total SD 0.006; pCO2 Total SD 2.3, %CV 6.1; pO2 Total SD 3.0, %CV 2.6
Level 3 (pH 7.627, pCO2 20.1 mmHg, pO2 148.9 mmHg): pH Total SD 0.008; pCO2 Total SD 1.0, %CV 4.8; pO2 Total SD 3.4, %CV 2.3
Within-Run Whole Blood Precision	Acceptable Within-Run SD and %CV for pH, pCO2, and pO2 using fresh, native whole blood samples by POC operators, demonstrating consistent performance in replicate measurements.	pH: SD values ranging from 0.003 to 0.011 across 5 samples.
pCO2 (mmHg): %CV values ranging from 0.70% to 1.62% across 5 samples.
pO2 (mmHg): %CV values ranging from 0.80% to 4.73% across 5 samples. (Specific mean, SD, %CV provided for each of the 5 samples in Table 3)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Method Comparison:
- N = 432 for pH and pO2 (venous & arterial whole blood specimens combined)
- N = 428 for pCO2 (venous & arterial whole blood specimens combined)
Sample Size for Total Imprecision: 40 runs (duplicate measurements each day for 20 days) for each of 3 levels of quality control materials.
Sample Size for Within-Run Whole Blood Precision: 10 replicate measurements for each of 5 different native whole blood samples at each site.
Data Provenance: The studies were conducted at 3 Point-of-Care (POC) sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data provenance refers to real-world samples tested by clinical staff in typical POC settings. The report does not specify the country of origin, but given it's an FDA submission, it's typically understood to be within the U.S.
Nature of Data: The method comparison used "discarded blood gas specimens" and "quality control materials" in addition to "fresh, native whole blood samples" for within-run precision. This indicates retrospective usage of discarded patient samples and prospective collection for precision studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the method comparison study was established by "laboratory measurements" (presumably by a predicate or established laboratory analyzer). The document does not specify the number of experts or their qualifications who performed these laboratory measurements. The term "POC personnel" refers to the users of the device under test, not the ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe any specific "adjudication method" in the sense of multiple experts reviewing results and reaching a consensus. For method comparison studies of this type (quantitative measurements), the reference method (laboratory measurement) typically serves as the "ground truth" against which the new device's performance is compared, using statistical methods (slope, intercept, correlation, bias). No expert adjudication is typically involved beyond ensuring the reference method itself is properly calibrated and operated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done as described in the context of human readers improving with AI assistance. This device is an analyzer, not an AI-assisted diagnostic tool that interprets images or signals requiring human interpretation. The study involved different POC personnel operating the device, which is a form of multi-user testing to assess "imprecision performance" in a real-world setting, but it's not an MRMC study comparing human performance with and without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device operates in a standalone manner to measure pH, pCO2, and pO2. The "Point-of-Care (POC) study" assessed the device's performance when operated by healthcare professionals in clinical settings, but the device itself generates the quantitative measurements automatically. The "bench testing" mentioned, performed prior to the POC study, also represents standalone performance. The values in the tables are direct measurements from the device, not interpretations aided by humans.

7. The Type of Ground Truth Used

For Method Comparison Studies: The ground truth was established by "laboratory measurements" using presumably a reference laboratory analyzer or the predicate device.
For Imprecision Performance: The ground truth was based on the expected values of the "quality control materials" used.
For Within-Run Whole Blood Precision: The study evaluated the device's consistency when repeatedly measuring "fresh, native whole blood samples", where the ground truth is simply the intrinsic value of the sample, and the measurement aims to show reproducibility.

8. The Sample Size for the Training Set

This document only describes performance testing for regulatory submission (510(k)). It does not mention or provide details about a "training set" as would be relevant for machine learning algorithms. This device is a diagnostic instrument based on established electrochemical principles, not an AI/ML device that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established

As no training set is described for this type of device, this question is not applicable.

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K Number

K180340

Device Name

Manufacturer

Date Cleared

2018-09-26

(231 days)

Product Code

CGA,CDS,CGL

Regulation Number

862.1345

Type

Panel

Reference & Predicate Devices

Intended Use

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Glucose, Creatinine, and Blood Urea Nitrogen, in heparinized arterial and venous whole blood.

Glucose (Glu) Measurements are used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumor.
Creatinine (Creat) Measurements are used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen (BUN) Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Description

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards:

Primary Sensor Card Port:
There are two options for the primary sensor card:
. Primary Sensor Card 1 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2, O2Hb, COHb, MetHb, HHb
. Primary Sensor Card 2 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2

Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (Or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
Auxiliary Sensor Card 1 enables Creatinine and BUN parameters
. Auxiliary Sensor Card 2 is a "dummy" sensor card, and will not report any parameters.

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
. Stat Profile Prime Plus Analyzer System
Primary Sensor Cartridge
. Auxiliary Sensor Cartridge
Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
. Stat Profile Prime Plus Calibrator Cartridge
Stat Profile Prime Plus External Ampuled Control
IFU/Labeling

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria. The device in question is the Stat Profile Prime Plus Analyzer System, and the studies focus on its performance for measuring Glucose, Creatinine, and Blood Urea Nitrogen (BUN) in whole blood.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria & Reported Device Performance

The document states that the "blood comparison data for Glucose, Creatinine, and BUN, for the Stat Profile Prime Plus analyzers meet the acceptance criteria." While explicit numerical acceptance criteria are not presented in a table form, the performance is described relative to a predicate device (Stat Profile pHOx Ultra Analyzer System) and internal specifications. The linearity and precision studies also explicitly state that the acceptance criteria were met.

For a clearer representation, we can infer the acceptance criteria and performance based on the descriptions:

Performance Metric	Acceptance Criteria (Inferred from text)	Reported Device Performance
Method Comparison	Demonstrated equivalence to the predicate device (Stat Profile pHOx Ultra Analyzer) for Glucose, Creatinine, and BUN measurements in heparinized whole blood.	"The blood comparison data for Glucose, Creatinine, and BUN, for the Stat Profile Prime Plus analyzers meet the acceptance criteria." (Implies equivalence was successfully demonstrated).
Precision (Within Run)	Meet specified imprecision limits for within-run performance.	"The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers."
Precision (Run to Run)	Meet specified imprecision limits for between-analyzer run-to-run performance.	"The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers."
Linearity	Good correlation and linearity to reference analyzers across the claimed measurement range, meeting acceptance criteria.	"The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."
Specificity/Interference	Identify significant interferents and determine concentrations at which interference occurs, with implied acceptable levels of bias for non-interfering substances.	Specific interfering substances (Hydroxyurea, Oxalate, Thiocyanate) were identified for Glucose and Creatinine at certain concentrations, showing bias. Conversely, "No interference observed" below certain concentrations. (This implies that at clinically relevant concentrations, significant interference is either absent or managed). For example, Hydroxyurea for Glucose: no interference at 0.2 mg/dL, bias of 19.2% at 0.4 mg/dL.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Precision/Reproducibility - Within Run: 20 replicates for one run of each of the following: internal controls (Levels 1-5), ampuled controls (Levels 1-5), and two whole blood samples (from syringes).
- Precision/Reproducibility - Run to Run: Triplicate analyses performed on a single whole blood sample in ten separate runs.
- Linearity Testing: Not explicitly stated, but performed using "various medical decision limits" and comparing to reference analyzers.
- Specificity/Interference Testing: Conducted using whole blood collected in lithium heparin vacutainers. Possible interfering substances tested at two analyte concentrations for each. The number of unique samples or overall sample size for this study is not explicitly stated beyond "many substances were screened".
- Method Comparison Studies: Performed to compare the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer in a clinical laboratory setting. The number of samples is not specified.
Data Provenance: The studies were performed in a "clinical laboratory setting" and involved "whole blood" samples. The document does not specify the country of origin for the data or explicitly state whether it was retrospective or prospective. Given the nature of performance testing for a medical device, it is typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable (N/A) to this device and study type. This device is an in-vitro diagnostic (IVD) analyzer that quantitatively measures analytes (Glucose, Creatinine, BUN). The "ground truth" for its performance studies is established by:

Reference Methods/Analyzers: For method comparison and linearity studies.
Known Concentrations: For controls and linearity samples.
Established Analytical Specifications: For precision and interference studies.

There are no human experts classifying images or clinical conditions, so there is no panel of experts to establish a "ground truth" in the way described for AI/CADe systems.

4. Adjudication Method for the Test Set

This information is N/A. As explained above, the ground truth is based on quantitative measurements against reference methods or known concentrations, not on expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is N/A. This device is an analytical instrument for quantitative measurements, not an AI/CADe system designed to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is N/A. This device is a standalone analyzer. Its "performance" is its standalone capability to accurately and precisely measure analytes. There is no human-in-the-loop component in its direct operation for measurement that would require a separate "human-in-the-loop performance" study. The studies described (method comparison, precision, linearity, interference) directly evaluate the standalone performance of the instrument.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this device's performance studies is based on:

Reference Measurement Methods/Instruments: For comparison studies (e.g., comparing the Prime Plus Analyzer's results to those from the predicate device or other established reference analyzers).
Known and Certified Control Materials: For quality control and precision studies, where the true concentration of analytes in the control samples is known.
Spiked Samples: For linearity and interference studies, where samples are spiked with known concentrations of analytes or interfering substances.

8. The Sample Size for the Training Set

This information is N/A. This document describes the validation of a hardware-based analytical instrument with established biochemical measurement principles, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's measurement algorithms are based on scientific principles (e.g., enzymatic reactions, electrochemistry, Nernst equation) and are not "trained" on data in the way an AI model would be.

9. How the Ground Truth for the Training Set Was Established

This information is N/A for the same reasons as point 8.

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K Number

K180186

Device Name

Manufacturer

Date Cleared

2018-08-23

(212 days)

Product Code

GGZ,GHS,GKK,GKR,JPI

Regulation Number

864.7500

Type

Panel

Reference & Predicate Devices

Intended Use

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.

Device Description

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards.

Similar to the predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

AI/ML Overview

The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.

Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.

For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."

The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."

Parameter	Acceptance Criteria (Measurement Range) - as per Proposed Device	Reported Device Performance (as stated in sections 6 & 7)
SO2	30-100%	Met acceptance criteria for Method Comparison, Precision, and Linearity.
Hct	12-70%	Met acceptance criteria for Method Comparison, Precision, and Linearity.
tHb	5.0 - 25.0 g/dL	Met acceptance criteria for Method Comparison, Precision, and Linearity.
O2Hb	1.8-100%	Met acceptance criteria for Method Comparison, Precision, and Linearity.
COHb	0.3-60%	Met acceptance criteria for Method Comparison, Precision, and Linearity.
MetHb	0.3-60%	Met acceptance criteria for Method Comparison, Precision, and Linearity.
HHb	0.4-40%	Met acceptance criteria for Method Comparison, Precision, and Linearity.

Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.

Study Information:

Sample size used for the test set and the data provenance:
- Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
- Precision/Reproducibility - Within Run and Run to Run Studies:
  - Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
  - Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
  - The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
- Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
- Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device requiring human interpretation; it directly measures parameters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:
- Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
- Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
- Linearity: Comparison against a "reference analyzer and/or the product specifications."
- Specificity/Interference: Comparison of measurements with and without potential interfering substances.
The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.
How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.

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K Number

K180428

Device Name

Manufacturer

Date Cleared

2018-08-15

(180 days)

Product Code

JGS,CEM,CFA,CGZ,JFP

Regulation Number

862.1665

Type

Panel

Reference & Predicate Devices

Intended Use

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

lonized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

lonized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium),

Device Description

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

Primary Sensor Card Port:

There are two options for the primary sensor card:

. Primary Sensor Card 1 shall enable and report the following listed analytes: o sodium, potassium, chloride, ionized calcium, and ionized magnesium
. Primary Sensor Card 2 shall enable and report the following listed analytes:

sodium, potassium, chloride, ionized calcium, and ionized magnesium o

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood qas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

Stat Profile Prime Plus Analyzer System Components:

The Stat Profile Prime Plus Analyzer System is comprised of the following components.

Stat Profile Prime Plus Analyzer System .
Primary Sensor Cartridge
Auxiliary Sensor Cartridge ●
Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
Stat Profile Prime Plus Calibrator Cartridge ●
Stat Profile Prime Plus External Ampuled Control ●
IFU/Labeling .

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Nova Biomedical Corporation Stat Profile Prime® Plus Analyzer System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the studies "meet the acceptance criteria" or "met the acceptance criteria" without explicitly listing the numerical acceptance criteria for many tests. The performance is reported as meeting these unstated criteria.

Parameter Tested	Acceptance Criteria (Not explicitly stated numerically in document)	Reported Device Performance
Method Comparison (Equivalence to Predicate)	The blood comparison data for sodium, potassium, chloride, ionized calcium, and ionized magnesium for the Stat Profile Prime Plus analyzers meet the acceptance criteria.	"The blood comparison data for sodium, potassium, chloride, ionized calcium, and ionized magnesium for the Stat Profile Prime Plus analyzers meet the acceptance criteria."
Precision/Reproducibility
Within Run Precision	Meet within run imprecision specifications.	"The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers."
Run to Run Precision	Meet between analyzer run to run imprecision specifications.	"The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers."
Linearity Testing	Good correlation and linearity to reference analyzers across the claimed measurement range for all parameters, and met acceptance criteria.	"The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."
Specificity / Interference Testing	No interference observed, or bias within acceptable limits at specified concentrations.	Most substances showed "No interference observed" at certain concentrations, while others showed a "Bias" at higher concentrations (e.g., Chloride with Bromide and Thiocyanate, Ionized Calcium with MgCl2, Ionized Magnesium with Perchlorate, Thiocyanate, and ZnCl2).

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison Study:
- Sample Size: Not explicitly stated. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using "blood comparison data."
- Data Provenance: Conducted in a "clinical laboratory setting" as indicated by the study description. It is a prospective study as it involves active comparison of devices.
Precision/Reproducibility Studies:
- Within Run Precision: 20 replicates per run for each of the following: Stat Profile Prime Plus Internal Controls (Levels 4-5), Stat Profile Prime Plus Ampuled Controls (Levels 4-5), and three whole blood samples from syringes.
- Run to Run Precision: Triplicate analyses on four whole blood samples in ten separate runs during a single day.
- Data Provenance: The document doesn't specify country of origin. This appears to be prospective data generated for the study.
Linearity Testing:
- Sample Size: Not explicitly stated, beyond indicating "various medical decision limits" and "lower and upper limits of the AMR."
- Data Provenance: Generated for the study.
Specificity / Interference Testing:
- Sample Size: Not explicitly stated for the number of samples, but tests were performed at "two analyte concentrations" for each potential interferent.
- Data Provenance: Whole blood collected in lithium heparin vacutainers was used for this study. Generated for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is an in vitro diagnostic device that directly measures analytes. The ground truth for performance studies is typically established by reference methods or validated predicate devices, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or data, and their initial interpretations need to be resolved by a consensus process. For an IVD device measuring analytes, the 'ground truth' is determined by the reference method's result, or the established result of a predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an In Vitro Diagnostic (IVD) analyzer, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, the studies described (Method Comparison, Precision, Linearity, Specificity/Interference) evaluate the standalone performance of the Stat Profile Prime Plus Analyzer System. The device directly measures the analytes and reports the results without human interpretation as part of its core function, other than healthcare professionals using the results for diagnosis and treatment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance studies was established by:

Comparison to a predicate device: For the method comparison study, the Nova Stat Profile pHOx Ultra analyzer (K110648) served as the reference point for equivalence.
Reference analyzers/specifications: For linearity testing, results were compared to "the reference analyzer and/or the product specifications."
Internal controls and ampuled controls: For precision, these served as samples with known or expected values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a separate training set. The device operates based on established electrochemical principles (Ion-Selective Electrode) and measurement algorithms.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set in the context of machine learning was used.

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K Number

K173797

Device Name

Manufacturer

Date Cleared

2018-07-17

(215 days)

Product Code

CHL

Regulation Number

862.1120

Type

Panel

Reference & Predicate Devices