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510(k) Data Aggregation
(318 days)
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.
PC02,P02,pH: Whole blood measurement of certain gases in whole blood,or pH of whole blood,is used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states,such as anemia and erythrocytosis (an increase in the number of red cells).
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension, Addison's disease,dehydration,or diseases involving electrolyte imbalance.
K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
iCa: 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).
Glu: 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.
Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients lactic acidosis.
The Stat Profile Prime Auto QC Cartridge CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glucose and Lactate using the Stat Profile Prime CCS Analyzer.
Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.
The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.
Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose) and Lac (Lactate). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.
The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:
- traditional sensor technology to measure blood pO2 ●
- ion selective electrode technology to measure pH, pCO2, blood sodium, potassium, chloride, and ionized calcium
- enzyme/Amperometric technology for glucose measurements
Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.
Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge agueous solutions allow for 2 point calibration of each parameter as follows:
- Calibrator A pH, PCO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 500 mL) ●
- Calibrator B pH, PO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 250 mL) .
- Calibrator F PCO2, PO2 (Volume > 720 mL) ●
- Reference Solution KCI (Volume > 300 mL) .
The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, Cl, iCa, Glucose (Glu) and Lactate. The solutions are equilibrated with known levels of 02, CO2, and N2. Each ampule contains 1.7 ml volume.
The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, Glucose (Glu) and Lactate. The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl. iCa. Glucose (Glu) and Lactate. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:
- . Control 1: Acidosis, with High Electrolyte, Low Normal Glu, and Lactate
- Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu, and Lactate ●
- . Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, and Lactate
Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, Lactate, K+, and Cl-. Each ampule contains 1.8 ml volume.
The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.
Here's a summary of the acceptance criteria and the study details for the Stat Profile® Prime CCS Analyzer System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each parameter (e.g., a specific bias range for method comparison). Instead, it presents the results of equivalency studies against a predicate device and within the device itself (capillary vs. syringe, POC vs. trained healthcare professional). The implication is that the performance shown in these tables met the internal acceptance criteria for substantial equivalence to the predicate and for safe and effective use.
I will formulate a table focusing on the Method Comparison and Point-of-Care (POC) vs. Trained Healthcare Professional (THP) studies, as these directly compare the device's performance to established methods or user groups. The "Acceptance Criteria" column will represent the implicit expectation of strong correlation (high 'r' value, slope near 1, intercept near 0) for substantial equivalence and reliable performance.
| Parameter (Analyte) | Study Type | Acceptance Criteria (Implicit) | Reported Device Performance (Slope, Intercept, r) |
|---|---|---|---|
| pH | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 (strong correlation) | 0.9976, 0.0099, 0.9985 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0094, -0.0721, 0.9988 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.983, 0.116, 0.997 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.962, 0.275, 0.997 | |
| PCO2 | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9854, 0.9344, 0.9977 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0026, -0.4347, 0.9989 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.007, 0.750, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.989, 0.899, 0.998 | |
| PO2 | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9897, 1.4508, 0.9988 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9942, 2.1791, 0.9996 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.005, -0.094, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.979, 3.141, 0.999 | |
| Hct | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0445, -1.9271, 0.9889 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0013, 0.0485, 0.9963 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.997, 0.395, 0.985 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.978, 0.399, 0.984 | |
| Na+ | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0189, -2.2841, 0.9955 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9995, -0.1711, 0.9978 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.020, -2.540, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.010, -1.258, 0.997 | |
| K+ | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0163, -0.0371, 0.9996 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9966, 0.0934, 0.9996 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.974, 0.110, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.006, -0.025, 0.998 | |
| iCa | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9880, 0.0457, 0.9974 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0228, -0.0603, 0.9855 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.001, 0.004, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.977, 0.029, 0.996 | |
| Cl- | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0003, 1.0158, 0.9955 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9897, 0.1776, 0.9997 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.000, -0.020, 0.999 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.007, -0.710, 0.997 | |
| Glu | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0007, -2.6844, 0.9892 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9855, -0.4734, 0.9998 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.989, 1.517, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.004, 0.036, 0.999 | |
| Lac | Method Comparison (vs. Predicate) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 0.9841, -0.0937, 0.9974 |
| Capillary vs. Syringe | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.0034, -0.0120, 0.9994 | |
| POC vs. THP (Syringe) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.018, -0.093, 0.998 | |
| POC vs. THP (Capillary) | Slope ≈ 1, Intercept ≈ 0, r ≈ 1 | 1.019, -0.127, 0.998 | |
| Lactate Limit of Detection (LoD) | Total Error ≤ 0.3 (mmol/L) | 0.13 (mmol/L) | |
| Lactate Linearity (r value for individual analyzer) | r ≈ 1 | 0.9992, 0.9994, 0.9993 (for 3 analyzers) | |
| General | Interference Testing (Lactate) | Bias < ±10% for non-interfering substances | Various substances tested with no significant interference. Glycolic acid (0.25 mmol/L) showed 11.7% bias, Hydroxyurea (0.2 mg/dL) showed 20.1% bias. |
| Total Imprecision (e.g., pH Level 1) | Low SD and %CV | pH: 0.007 SD, 0.10% CV | |
| Total Imprecision (e.g., Lac Level 1) | Low SD and %CV | Lac: 0.02 SD, 2.0% CV |
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison (vs. Predicate):
- Sample Size: A minimum of 150 whole blood specimens for each parameter (ranging from 167 for pO2 to 186 for Cl).
- Data Provenance: Not explicitly stated, but the samples were whole blood specimens. Given the context of seeking FDA clearance in the US, it's highly probable the data was collected within the United States. It used a predicate device (Stat Profile pHOx Ultra) for comparison, implying a retrospective comparison against results obtained from the predicate or concurrently with the predicate. The statement "Some samples were altered in order to achieve the hard-to-find sample range" suggests a controlled, laboratory-based study, likely prospective for the new device.
- Capillary vs. Syringe Equivalency:
- Sample Size: Approximately 100 whole blood samples for each parameter (ranging from 98 for iCa to 100 for others).
- Data Provenance: Not explicitly stated, but implies a controlled, likely prospective study comparing two sampling modes on the same device.
- Point-of-Care (POC) vs. Trained Healthcare Professional (THP):
- Sample Size:
- Syringe Mode: Ranged from 222 (Hct) to 234 (pH, PO2, iCa, Cl) specimens.
- Capillary Mode: Ranged from 157 (Hct) to 173 (pH, PO2, iCa, Cl, Glu, Lac) specimens.
- Data Provenance: The study was conducted in 3 POC sites (cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU), and a trauma/neuro intensive care unit). All testing used "discarded blood gas specimens." This implies a prospective study using real-world patient samples collected at these clinical sites.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Method Comparison: The predicate device, Stat Profile pHOx Ultra, was used as the comparative method. The "ground truth" for the new device's performance was established by comparing its results to the average of two results from the pHOx Ultra comparative method. This means the "experts" were the established and validated measurement capabilities of the predicate device, not human experts in interpreting results.
- Capillary vs. Syringe: The "ground truth" for comparison was the syringe sample results from the same new device.
- Point-of-Care (POC) vs. Trained Healthcare Professional (THP): The "ground truth" for comparison was the results obtained by "Trained Healthcare Professionals" (THP) also using the new device. The qualifications for THP are simply stated as "trained Healthcare Professionals." While the POC personnel included 43 respiratory therapy and 10 Nursing POC personnel from 3 POC settings, the specific qualifications of the "Trained Healthcare Professionals" are not detailed.
4. Adjudication Method for the Test Set
- Method Comparison: The ground truth involved the average of 2 results from the predicate device (pHOx Ultra). If these two results were the reference method, it implies an internal comparison against a standard, not an adjudication process among human readers.
- Capillary vs. Syringe & POC vs. THP: These studies involved direct comparison between two measurements from different methods/users. There's no mention of a separate adjudication process.
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 performed. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that interprets images or provides a diagnosis. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this is essentially a standalone performance study for an automated in vitro diagnostic device. The device itself (its sensors and integrated system) performs the measurements. The comparison studies (Method Comparison, Capillary vs. Syringe) evaluate the analytical performance of the algorithm/device itself.
- The POC study implicitly evaluates the human-in-the-loop aspect for correct operation of the device by different user groups, but the measurement itself is performed by the standalone instrument.
7. The Type of Ground Truth Used
- Established Reference Method/Predicate Device: For the method comparison, the "ground truth" was established by the predicate device (Stat Profile pHOx Ultra), which is itself a legally marketed and presumably validated medical device. For Lactate linearity, the pHOx Ultra analyzers were used to establish the "target value" of each blood level.
- Internal Device Consistency: For the capillary vs. syringe study, the syringe measurement mode on the new device served as the reference for the capillary mode.
- Trained Professional Reference: For the Point-of-Care study, the measurements taken by "Trained Healthcare Professionals" using the new device served as the reference for measurements taken by POC personnel.
8. The Sample size for the training set
The document describes performance testing for substantial equivalence, not the development or training of an algorithm for the device. Therefore, a "training set" in the context of machine learning or AI is not applicable to this submission. The device relies on traditional sensor technology and measurement algorithms, which are engineered and validated rather than "trained" with data sets in the AI sense.
9. How the ground truth for the training set was established
As there is no explicit "training set" mentioned or implied for an AI algorithm, this question is not applicable to the information provided. The "ground truth" for the device's development and validation would have been established through a combination of engineering specifications, chemical/electrical standards, and established reference methods/materials for each analyte.
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