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The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections.

The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products.

The HSV 1&2 ELITe MGB Assay is a qualitative in vitro diagnostic Real-Time PCR Assay for the direct detection of Herpes Simplex Virus (HSV) DNA (glycoprotein D gene for HSV-1 and glycoprotein G gene for HSV-2) in symptomatic male and female patients using DNA purified from swab specimens collected from individuals with cutaneous or mucocutaneous herpetic lesions.

The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes.

An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited.

The amplification reagents, Positive Control and Internal Control are packaged as part of the HSV 1&2 ELITe MGB Assay.

Here's a breakdown of the acceptance criteria and study information for the HSV 1&2 ELITe MGB Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HSV 1&2 ELITe MGB Assay are presented in terms of Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) against a composite reference method.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 1,174 prospectively collected archived swab samples were initially collected. After exclusions:
     • 1,171 samples were analyzed for HSV-1.
     • 1,170 samples were analyzed for HSV-2.
     • A separate contrived oral panel study involved 75 individual negative cheek swab samples spiked with HSV-2, plus 10 HSV-1 positive samples and 15 HSV-1/HSV-2 negative oral samples.
   • Data Provenance: The samples were "left-over prospectively collected archived swab samples" from symptomatic patients. The country of origin is not explicitly stated, but the context of an FDA submission generally implies US-based data.

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

   • The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. The ground truth was established using a composite reference method.

3. Adjudication Method for the Test Set:

   • The adjudication method for the test set was a "composite reference method" defined as: "an FDA cleared assay and a validated HSV 1&2 PCR followed by bi-directional sequencing of gel electrophoresis-positive samples."
   • "A positive result by the composite reference method is defined as a positive by the FDA cleared PCR or the validated sequencing. Two negative results are needed to confirm a negative." This implies a type of adjudicted consensus, where the "truth" is determined by agreement or hierarchical resolution between different methods, rather than human experts per se.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This document describes the analytical and clinical performance of an in vitro diagnostic (IVD) assay, which is an algorithm-only (standalone) test. It does not involve human readers in the primary diagnostic decision-making process that would warrant an MRMC study comparing human performance with and without AI assistance.

5. If a Standalone Performance Study Was Done:

   • Yes. The entire clinical performance section (Section 11.b) is a standalone performance study where the HSV 1&2 ELITe MGB Assay's performance is compared directly against a composite reference method. The assay operates without human intervention in the interpretation of results.

6. The Type of Ground Truth Used:

   • Composite Reference Method: This ground truth combined an FDA-cleared PCR assay and a validated HSV 1&2 PCR followed by bi-directional sequencing. This type of ground truth integrates highly sensitive and specific molecular methods, reflecting a robust laboratory-based gold standard.

7. The Sample Size for the Training Set:

   • The document does not explicitly mention a "training set" in the context of an AI/ML algorithm. This device is a real-time PCR assay, which is a chemical and enzymatic reaction rather than a machine learning model that would typically require a separate training set. The various analytical performance studies (Limit of Detection, Analytical Reactivity, Specificity, etc.) serve to characterize the assay's performance across different conditions, which is analogous to how a system is "trained" or refined during development, but not in the sense of a distinct machine learning training set. The "assay cut-off" was established using a separate set of 141 clinical samples, which could be considered a form of calibration/training for the threshold of positivity.

8. How the Ground Truth for the Training Set Was Established:

   • As noted above, a traditional "training set" for an AI model is not applicable here. For the establishment of the assay cut-off (using 141 clinical samples), the ground truth was established using the same "composite reference method" (FDA-cleared real-time PCR assay combined with PCR amplification and bidirectional sequencing). For other analytical studies (like LoD, inclusivity, cross-reactivity), quantitated viral strains or characterized organisms were used as the reference.

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The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.

The provided document is an FDA 510(k) Premarket Notification for the Macroduct Advanced Model 3710 Sweat Collection System. This device is an iontophoresis device intended for the stimulation and collection of sweat for the diagnosis of cystic fibrosis.

The document focuses on demonstrating substantial equivalence to a predicate device (Macroduct Model 3700-SYS) rather than presenting a study proving a specific performance claim against established acceptance criteria using a novel algorithm or AI. Therefore, many of the requested elements for an AI/algorithm-based study (like MRMC studies, training/test set sample sizes, ground truth establishment for AI, etc.) are not applicable to this type of submission.

The "acceptance criteria" in this context refer to the device meeting the requirements for substantial equivalence, primarily by demonstrating that modifications do not introduce new safety or effectiveness concerns and that the device performs like the predicate.

Here's a breakdown of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

For a substantial equivalence submission like this, "acceptance criteria" are typically related to maintaining the same fundamental function, safety, and effectiveness as the predicate device. The performance is demonstrated by showing that the modifications do not negatively impact these aspects.

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ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.

It is not intended for use in Point of Care settings.

Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only. Each kit consists of a bi-reagent R1 & R2.

ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Reagent 1: R1 Sulphanilic acid 29 mmol/L, Cetrimide 29 mmol/L.
Reagent 2: R2 Sodium nitrite 11 mmol/L.

ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Reagent 1: R1 Sulphanilic acid 29 mmol/L,
Reagent 2: R2 Sodium nitrite 11 mmol/L.

The document describes the analytical performance and comparison studies for the ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 devices. These devices are intended for the quantitative in vitro diagnostic determination of total and direct bilirubin, respectively, in human serum and plasma. The studies aim to demonstrate substantial equivalence to predicate devices (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP).

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For ELITech Clinical Systems BILIRUBIN TOTAL 4+1:

For ELITech Clinical Systems BILIRUBIN DIRECT 4+1:

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

• Precision (Test Set):

  • Sample Size: 80 measurements for each of 3 levels of samples (total 240 measurements per device) per instrument (2 instruments used).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "samples" or "patient samples." The study was prospective in the sense that controlled experiments were performed to gather data for precision.

• Linearity (Test Set):

  • ELITech Clinical Systems BILIRUBIN TOTAL 4+1: 11 levels of mixed samples.
  • ELITech Clinical Systems BILIRUBIN DIRECT 4+1: 11 levels of mixed samples.
  • Data Provenance: Not explicitly stated. Likely prepared in a laboratory setting.

• Detection Limit (Test Set):

  • Sample Size: 15 measurements of 4 samples for each device.
  • Data Provenance: Prepared from patient samples and diluted with Albumin 6 g/dL - NaCl 0.9 %.

• Interference (Test Set):

  • Sample Size: For each potential interferent, 2 serum sample pools (low and high concentration), with aliquots spiked at various interferent concentrations (9 or 7 or 8 different concentrations). Each point was measured in triplicate per run. Two levels of control were also tested. A control sample was prepared from the sample pool diluted in appropriate diluent.
  • Data Provenance: "Serum sample pools." Not explicitly stated.

• Method Comparison (Test Set):

  • Sample Size: 100 serum patient samples for each device.
  • Data Provenance: "Serum patient samples." Not explicitly stated, but likely from a clinical laboratory or hospital in the country where the studies were conducted (France or USA, as these are locations given for the submitter and contact person). The study was likely prospective in nature for collecting these samples for comparison against the predicate.

• Matrix Comparison (Test Set):

  • Sample Size: 40 plasma patients (lithium heparin samples) for each device.
  • Data Provenance: "Plasma patients." Not explicitly stated. Likely from a clinical laboratory or hospital.

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 (quantitative measurement of bilirubin), the "ground truth" is typically established by reference methods or comparison to legally marketed predicate devices, not by expert interpretation. The predicate devices are considered the "ground truth" for the method comparison studies. The document implicitly uses the performance of the legally marketed predicate device (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP) as the standard against which the new device's performance is compared for substantial equivalence.

There is no mention of experts establishing ground truth in the traditional sense of medical imaging or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro diagnostic device performing quantitative measurements, not an AI or imaging device requiring human adjudication of results. The performance is assessed by comparing quantitative results against reference or predicate methods.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for imaging devices where human readers interpret medical images with and without AI assistance. The described device is an in vitro diagnostic assay.

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

Yes, the studies described are standalone performance evaluations of the device (reagents on an analyzer). The device itself (the reagent system) functions as an "algorithm only" in the sense that it performs the chemical reaction and measurement without human interpretive input for each test result. Clinical laboratory technologists would operate the analyzer and interpret the numerical results, but the analytical performance described is the device's intrinsic capability.

7. The Type of Ground Truth Used

The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate devices (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP). In the method comparison studies, the results from the new devices are compared against the results from the predicate devices using patient samples.

Additionally, for analytical performance like linearity, detection limit, and interference, the "ground truth" for evaluating the performance of the device is based on prepared samples with known concentrations or expected behaviors (e.g., spiked samples with interferents, serially diluted samples).

8. The Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic reagent system, not an AI/ML-based device that requires a "training set" in the computational sense. Its performance is based on chemical reactions and instrumental measurements, which are validated through analytical studies.

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

Not applicable, as there is no "training set" for this type of device.

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ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.

ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide

The provided document describes the analytical performance of the ELITech Clinical Systems GLUCOSE HK SL reagent, ELICAL 2 calibrator, and ELITROL I/II controls. It does not describe an AI/ML powered device, therefore no information is available regarding expert consensus, MRMC studies, or multi-reader performance. The study described focuses on demonstrating substantial equivalence to predicate devices for in vitro diagnostic use.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines acceptance criteria implicitly through the study design (e.g., acceptance bias for interference studies) and generally through comparison to a predicate device. Performance is reported through various analytical studies.

ELITech Clinical Systems GLUCOSE HK SL Reagent Performance Summary:

• Level 1 (45.5 mg/dL): Within-run CV% 1.1, Total CV% 2.0
• Level 2 (119.5 mg/dL): Within-run CV% 0.9, Total CV% 1.7
• Level 3 (251.5 mg/dL): Within-run CV% 0.9, Total CV% 2.0
• Level 4 (522.5 mg/dL): Within-run CV% 0.4, Total CV% 1.8
  Urine:
• Level 1 (18.0 mg/dL): Within-run CV% 0.9, Total CV% 2.0
• Level 2 (204.4 mg/dL): Within-run CV% 0.7, Total CV% 1.7
• Level 3 (497.4 mg/dL): Within-run CV% 0.6, Total CV% 1.7 |
  | Linearity/Assay Range | Serum: Demonstrated linearity for reported range (20 - 720 mg/dL).
  Urine: Demonstrated linearity for reported range (10 - 720 mg/dL). | Serum: Linear range: 20 - 720 mg/dL (y = 1.025x - 2.0 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.0 mg/dL). Auto-dilution to 3600 mg/dL.
  Urine: Linear range: 10 - 720 mg/dL (y = 1.0155x - 1.6 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 3.5 mg/dL). Auto-dilution to 3600 mg/dL. |
  | On-board Stability | 28 days for the reagent. | Reagent: 28 days on-board.
  Shelf-life: 27 months (real-time studies for 36 months). |
  | Limit of Detection (LoD) | Not explicitly stated, but clinical relevance and comparison to predicate device would be implicit. | Serum: 0.3 mg/dL
  Urine: 0.2 mg/dL |
  | Limit of Quantification (LoQ) | Serum: Acceptable Total Error ≤ 0.32 mg/dL; value must be ≥ LoD.
  Urine: Acceptable Total Error ≤ 0.8 mg/dL; value must be ≥ LoD. | Serum: 5.00 mg/dL
  Urine: 5.00 mg/dL |
  | Interference/Analytical Specificity | Accepted bias of ±10% in sample pools with low (50.0 mg/dL for serum, 18.0 mg/dL for urine) or high (120.0 mg/dL for serum, 200.0 mg/dL for urine) nominal activity. Specific interferent concentrations are also listed in the table. | Serum: No significant interference up to listed concentrations for unconjugated bilirubin (30.0 mg/dL), conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), triglycerides (600 mg/dL - note: negative bias observed at higher levels), ascorbic acid (20.0 mg/dL), uric acid (20.0 mg/dL), methyl dopa (2.0 mg/dL), L-dopa (30.0 mg/dL), Tolazamide (50.0 mg/dL), and acetaminophen (30 mg/dL).
  Urine: No significant interference up to listed concentrations for conjugated bilirubin (29.5 mg/dL), hemoglobin (500 mg/dL), uric acid (100 mg/dL), and urea (6000 mg/dL). No significant interference for pH (2.5 to 12.0) and specific gravity (1.000 to 1.030). |
  | Method Comparison (Correlation) | Demonstrate substantial equivalence to the predicate device (Roche Diagnostics Cobas C111 Glucose HK). | Serum: Against Cobas C111: y = 1.008 x + 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 2.7 mg/dL.
  Urine: Against Cobas C111: y = 0.996 x - 0.4 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 3.5 mg/dL.
  Plasma (Lithium Heparin): y = 1.001x - 0.7 mg/dL, r = 1.000, r2 = 1.000, Sy.x = 1.9 mg/dL.
  Plasma (Sodium Fluoride/Oxalate): y = 1.016x - 0.9 mg/dL, r = 0.999, r2 = 0.998, Sy.x = 7.0 mg/dL. |

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

• Precision Studies:

  • Serum: 80 measurements for each of 4 levels (total of 320 measurements). Samples were human sera and control sera.
  • Urine: 80 measurements for each of 3 levels (total of 240 measurements). Samples were urine pools.
  • Provenance: Not specified, but likely from laboratory samples as part of a method validation. Neither retrospective nor prospective status is explicitly stated, but analytical performance studies are generally conducted prospectively on prepared samples or collected patient samples.

• Linearity Studies:

  • Serum: 11 levels of mixed samples.
  • Urine: 11 levels of mixed samples.
  • Provenance: Not specified, but likely prepared in a laboratory.

• Interference Studies:

  • Serum: Two serum sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations (e.g., 9 for triglycerides, 7 for bilirubin). Each point measured in triplicate per run. Two levels of control materials also tested.
  • Urine: Two urine sample pools (low and high glucose activity), spiked with increasing interferent concentrations. Each interferent tested across multiple concentrations. Each point measured in triplicate per run. Two levels of control materials also tested.
  • Provenance: Not specified, but laboratory prepared spiked samples.

• Method Comparison Studies (Test Set):

  • Serum: 100 serum patient samples (ranging from 20.5 to 707.5 mg/dL).
  • Urine: 40 urine patient samples (with glacial acetic acid as preservative, ranging from 10.1 to 703.9 mg/dL).
  • Plasma (Lithium Heparin): 40 plasma patient samples (ranging from 24.3 to 710.1 mg/dL).
  • Plasma (Sodium Fluoride/Oxalate): 40 plasma patient samples (ranging from 21.2 to 701.4 mg/dL).
  • Provenance: "patient samples" implies retrospective or prospectively collected clinical samples. The country of origin is not specified but given the submitter's address (France and USA), it could be either.

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

Not applicable, as this is an in-vitro diagnostic test measuring a quantitative analyte (glucose). The "ground truth" for the test set is established by the reference method (Roche Diagnostics Cobas C111 Glucose HK) or known values/concentrations for engineered samples in analytical studies.

4. Adjudication Method for the Test Set:

Not applicable, as this is an in-vitro diagnostic test. Results are quantitative measurements compared against a reference method or known values, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

Not applicable, as this is an in-vitro diagnostic test. There is no human reader involvement in interpreting the device's quantitative output.

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

Yes, the studies described are all "standalone" in the sense that they evaluate the analytical performance of the device (reagent, calibrator, controls) on an automated analyzer (ELITech Clinical Systems Selectra ProM Analyzer) without human intervention in the result determination process.

7. The Type of Ground Truth Used:

• Known concentrations: For linearity, LoD/LoQ, and interference studies, samples were prepared to have known or target concentrations of glucose and interferents.
• Reference method/device: For method comparison studies, the predicate device (Roche Diagnostics Cobas C111 Glucose HK) was used as the comparative "ground truth" for patient samples.
• NIST Traceability: For calibration, the glucose value assigned to the calibrator (ELICAL 2) is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML powered device, so there is no "training set." The device performance is based on the chemical reagent's properties and the analyzer's measurement capabilities.

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

Not applicable (no training set).

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ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

It is not intended for use in Point of Care settings.

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

ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.

This document describes the performance of the ELITech Clinical Systems CALCIUM ARSENAZO IVD device. The information provided outlines the analytical performance characteristics and comparison studies rather than clinical or AI-assisted studies typically associated with detailed acceptance criteria of AI/ML-based medical devices.

Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, effect size of AI improvement, standalone AI performance) are not applicable to this type of device submission, which is for an in vitro diagnostic reagent. The "ground truth" here refers to established analytical methods and reference materials, not expert consensus on medical images or clinical outcomes data.

Here's a breakdown of the available information based on your request, focusing on the analytical performance studies conducted for this IVD reagent:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

The document doesn't present explicit "acceptance criteria" in a singular table for all performance characteristics against which the device passed or failed, but rather describes the methodology and results for each analytical performance study. The "acceptance criteria" are generally implied by standard clinical laboratory practices and regulatory expectations for IVD devices (e.g., CLSI guidelines, demonstrating substantial equivalence).

Device Performance Summaries (from the document):

2. Sample Size and Data Provenance:

• Precision Studies: 80 measurements for each of 3 levels for both serum and urine (total of 160 measurements per sample type across 20 operating days on 2 instruments).
• Linearity Studies: 11 levels of mixed samples for both serum and urine.
• Interference Studies: For each interferent, 2 sample pools (low and high calcium concentration) were tested, with aliquots spiked at various concentrations (7-9 different concentrations). Each point was measured in triplicate per run.
• Method Comparison (Serum): 106 serum patient samples.
• Method Comparison (Urine): 52 urine patient samples.
• Matrix Effect: 63 paired serum and plasma patient specimens.

Data Provenance: The document generally refers to "patient samples" but does not specify the country of origin. The studies are described as analytical performance evaluations, typically performed retrospectively on collected samples in a controlled laboratory setting. The submitting company is based in France.

3. Number of Experts and Qualifications:

Not applicable for this type of IVD analytical performance study. The ground truth for this device is based on quantitative chemical measurements, established analytical methods (e.g., predicate device, reference methods), and certified reference materials (NIST SRM 956c). Expertise is in analytical chemistry and clinical laboratory science for study design and interpretation, not expert medical opinion on, for example, image interpretation.

4. Adjudication Method:

None applicable. This is an analytical device for quantitative determination, not a diagnostic aid requiring adjudication of clinical findings or interpretations.

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

Not applicable. This is an IVD reagent, not an AI/ML-based diagnostic system for human-in-the-loop assistance.

6. Standalone (Algorithm Only) Performance:

This device is a chemical reagent. Its performance is inherent to its chemical reaction and measurement on a specific analyzer (ELITech Clinical Systems Selectra Pro Series Analyzers). Therefore, the concept of "standalone performance" as it applies to an AI algorithm is not applicable. The reported performance metrics (precision, linearity, LoD, LoQ, interference) are its standalone analytical performance.

7. Type of Ground Truth Used:

The ground truth for the analytical performance studies is established by:

• Reference materials: Such as NIST SRM 956c for traceability of calibration.
• Established analytical methods: Comparison against a legally marketed predicate device (ABX Pentra Calcium AS CP) and adherence to CLSI (Clinical and Laboratory Standards Institute) protocols (e.g., EP05-A2 for precision, EP06-A for linearity, EP17-A for detection limits, EP07-A2 for interference, EP09-A2 for method comparison).
• Gravimetric or Volumetric Preparations: For linearity and interference studies, samples are prepared by mixing known concentrations or spiking with known amounts of analytes/interferents.

8. Sample Size for Training Set:

Not applicable. This device is a chemical reagent, not an AI/ML model that requires a "training set." The performance characteristics are determined through standard analytical validation studies.

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

Not applicable for the same reason as above.

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ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes information about the ELITech Clinical Systems ELICAL 2 (calibrator) and ELITROL I & II (control sera), specifically for the addition of new constituents (IRON FERENE and MAGNESIUM XYLIDYL). It focuses on demonstrating substantial equivalence to predicate devices rather than independent clinical performance studies for complex AI/ML devices. Therefore, much of the requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable or not present in this document.

However, I can extract the acceptance criteria and performance related to the stability and value assignment for these in vitro diagnostic devices. The studies conducted are primarily focused on demonstrating the equivalency of the new lots/constituents to the existing product and predicate devices, and ensuring appropriate stability and accurate value assignment.

Here's an attempt to structure the available information according to your request, with explicit notes about what information is not present:

Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria and testing for ELITech Clinical Systems ELICAL 2 (calibrator) and ELITech Clinical Systems ELITROL I & II (control sera). The primary performance parameters evaluated are stability and value assignment. The study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

• 15-25°C: 8 hours
• 2-8°C: 2 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 3 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 6 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) | Lyophilized: Stable at 2-8°C until expiration date.
  After Reconstitution:
• 15-25°C: 12 hours
• 2-8°C: 5 days
• (-25)-(-15)°C: 4 weeks (frozen once)
  Exceptions (when stored protected from light):
• Direct Bilirubin: 15-25°C: 4 hours, 2-8°C: 8 hours, (-25)-(-15)°C: 2 weeks (frozen once)
• Total Bilirubin: 15-25°C: 8 hours, 2-8°C: 1 day, (-25)-(-15)°C: 2 weeks (frozen once) |
  | Reported Performance (Stability) | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. | Confirmed to meet acceptance criteria (stated by "The following is claimed for stability:" and "The devices met all acceptance criteria"). The reported stability values match the acceptance criteria as they are directly stated. |
  | Acceptance Criteria (Value Assignment) | For ELICAL 2: The mean analyte value is calculated based on measurements against appropriate standard reference material. Verification is performed by calibrating with new lot's assigned values and measuring quality control material at two levels, verifying that obtained values are within the labeled range of the quality control. | For ELITROL I & II: Target value for Level I and II is the median of the observed values range. A confidence range (high and low values) is calculated after validation of the target value. The expectation is that the controls perform as expected within these ranges. |
  | Reported Performance (Value Assignment) | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent QC measurements were within acceptance. | Confirmed to meet acceptance criteria (stated by "The performance data...demonstrate...that they met all acceptance criteria"). The process of value assignment described implies that the assigned values and subsequent confidence ranges were within acceptance. |
  | Substantial Equivalence | Demonstrated by comparison to predicate device K033501 (Roche Diagnostics Calibrator for Diagnostics Systems (C f.a.s)) showing similarities in intended use, format, level, handling, traceability, and stability. | Demonstrated by comparison to predicate device K041127 (Roche Diagnostics Precinorm U & Precipath U) showing similarities in intended use, format, levels, handling, and stability. |

2. Sample size used for the test set and the data provenance:

• ELICAL 2 (Calibrator):
  • For Value Assignment: "a target value is assigned on a minimum of 48 measurements taken." This is the number of measurements used to establish the value for each analyte.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics (a global company). The data is presented as prospective testing of new lots/constituents to establish their values and stability.
• ELITROL I & II (Control Sera):
  • For Value Assignment: "Each sample is tested in triplicate over several days using two separate ELITech Clinical Systems Selectra analyzers." A specific total number of measurements is not provided, but it implies multiple triplicate measurements.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The submitter, ELITech Clinical Systems SAS, is located in France. The predicate devices are Roche Diagnostics. The data is presented as prospective testing of new lots/constituents to establish their values and stability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is an in vitro diagnostic device for calibrators and control sera. The "ground truth" for these types of devices is established through analytical methods and reference materials, not expert consensus (e.g., radiologists interpreting images). The values are determined by analytical measurement against appropriate standards.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is established by analytical methods and reference materials, there is no expert adjudication process involved. The results are quantitative measurements compared against established standards or internal criteria.
  • For ELICAL 2, value assignment verification involved checking if measurements of quality control material fell within a labeled range.
  • For ELITROL I & II, the target value was the median of observed values, and a confidence range was calculated, indicating an analytical determination rather than adjudication.

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 document describes in vitro diagnostic calibrators and control sera, not AI-powered image analysis or diagnostic systems that involve human readers.

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

• Not Applicable. This document describes in vitro diagnostic calibrators and control sera. These devices are reagents used in automated analytical instruments (Selectra Pro Series Analyzers), and their performance is inherent to the chemical properties and manufacturing process, not an algorithm. The "performance" is how accurately and reproducibly they can be used to calibrate and control other assays, which is assessed analytically.

7. The type of ground truth used:

• Analytical Standards/Reference Materials & Internal Consistency:
  • For ELICAL 2 (Calibrator): The ground truth for value assignment is established by testing against "appropriate standard reference material" on two separate analyzers. This means the values are traced to known, highly accurate reference standards.
  • For ELITROL I & II (Control Sera): The "target value" is determined as "the median of the observed values range" from multiple measurements on two analyzers. This indicates an internal analytical consensus approach based on repetitive testing and statistical methods to establish the expected control range.

8. The sample size for the training set:

• Not Applicable / Not provided. These are in vitro diagnostic reagents, not AI/ML algorithms that require training sets in the computational sense. The document describes processes for establishing performance characteristics of a manufactured product (calibrators and control sera).

9. How the ground truth for the training set was established:

• Not Applicable. (See point 8).

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ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.

It is not intended for use in Point of Care settings.

Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,

for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism);

This document describes the performance characteristics and acceptance criteria for the ENVOY 500 CK REAGENT KIT, an in vitro diagnostic device for the quantitative determination of creatine kinase (CK) in human serum and plasma.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Test Set: 80 measurements for each of 3 levels of samples (Level 1, Level 2, Level 3). Each level was measured two times per run, for two runs per day, for twenty operating days, on two instruments.
• Linearity Test Set: 11 levels of patient pools (for serum).
• Detection Limit Test Set: 15 measurements of 4 samples for LoD; 15 measurements of 4 samples for LoQ.
• Interference Test Set: For each potential interferent, 2 serum sample pools (a low activity pool at 150 U/L and a high activity pool at 1200 U/L) were used. Aliquots of each pool were spiked with increasing interferent concentrations (e.g., 9 concentrations for triglycerides, 7 for unconjugated bilirubin, etc.). Each point was measured in triplicate per run.
• Method Comparison (Serum) Test Set: 100 serum patient samples.
• Method Comparison (Lithium Heparin Plasma) Test Set: 40 plasma specimens (in lithium heparin).
• On Board Stability Test Set: At least 3 levels of sample (high/medium/low) were tested in duplicate at Day 0, and 4 activity levels were analyzed in duplicate for at least 30 days.

Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. Given the submitter is ELITech Clinical Systems SAS, France, and the testing was conducted for regulatory submission in the US, it is plausible the studies were conducted in Europe or at contract research organizations. The nature of the studies (e.g., precision, linearity, interference, method comparison) generally involves prospective collection or commercially available control/patient samples for analytical validation.

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

This document describes the analytical performance of an in-vitro diagnostic reagent kit (ENVOY 500 CK REAGENT KIT). For such devices, "ground truth" generally refers to reference methods or measurements by highly calibrated instruments, not expert human interpretation. Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not applicable in this context. The ground truth for analytical studies is established by:

• Reference materials or calibrators traceable to international standards (e.g., IFCC method for CK).
• Predicate devices or established methods for method comparison studies.
• Precise gravimetric or volumetric preparations for linearity and spiking studies.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation of diagnostic images or data, where discrepancies between readers need to be resolved to establish ground truth for algorithm training or testing.

For the analytical performance studies described for the ENVOY 500 CK Reagent Kit, no such adjudication method was used or is applicable. The measurements are quantitative and objective, following established laboratory protocols and guidelines (e.g., CLSI protocols). Discrepancies would be resolved through re-testing, investigation of instrument or reagent issues, or statistical analysis (e.g., outliers).

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 document describes an in-vitro diagnostic reagent kit, not an AI-based diagnostic device intended for human reader assistance. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

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

This document describes the performance of an in-vitro diagnostic reagent kit that functions on a chemistry analyzer (Envoy 500 Chemistry System). The device itself is the reagent kit, which works in conjunction with the instrument to provide quantitative results. It is not an algorithm or AI-based device. The performance described is inherently "standalone" in the sense that it measures the analytical capability of the reagent-instrument system to quantify CK levels without human intervention in the measurement process itself, beyond sample loading and system operation. No human-in-the-loop performance is relevant for the analytical measurement part of the device's function.

7. The Type of Ground Truth Used

The ground truth for the various analytical performance characteristics was established using:

• Reference Methods/Standards: For traceability, the calibration factor for the ENVOY 500 CK Reagent Kit has traceability to the IFCC method (International Federation of Clinical Chemistry and Laboratory Medicine) recommendations for CK activity determination.
• Predicate Device Comparison: For method comparison, the predicate device (ELITech Clinical Systems CK NAC SL on Selectra ProM analyzer) served as the reference for comparison using patient samples.
• Prepared Samples/Known Concentrations:
  • For linearity, patient pools were prepared by spiking a serum pool and dilution to obtain 11 levels with equidistant activities (known relative concentrations).
  • For detection and quantification limits, samples were prepared by diluting patient samples to obtain specific activities (e.g., approximately 3.5 U/L for LoD, 5 U/L for LoQ).
  • For interference, serum sample pools were spiked with increasing concentrations of known interferents against control samples.
• Statistical Analysis: Precision studies rely on repeated measurements to quantify variability, with "ground truth" derived from the calculated mean and statistical metrics.

In summary, the ground truth is primarily based on reference methods (IFCC), comparison to a legally marketed predicate device, and precisely prepared samples with known (or highly characterized) concentrations/activities.

8. The Sample Size for the Training Set

Not applicable. This device is an in-vitro diagnostic reagent kit, not a machine learning or artificial intelligence-based device that requires a "training set" in the conventional sense. The "training" of such a system involves chemical formulation, optimization of reaction conditions, and calibration procedures using calibrators or reference materials.

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

Not applicable. As stated above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for developing and optimizing the reagent kit and its associated methods would involve:

• Chemical principles and stoichiometry: The understanding of the enzyme kinetics and chemical reactions being measured (e.g., the IFCC recommended method for CK).
• Reference materials and calibrators: Used to ensure accuracy and traceability of the quantitative measurements.
• Experimental optimization: Through iterative testing and modification of reagent concentrations, pH, and reaction conditions to achieve optimal performance characteristics (sensitivity, specificity, stability, etc.).

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MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Special conditions for use statement(s): Prescription Use Only.

MRSA/SA ELITe MGB® is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96-well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output. Cq, from the cycler (called Ct in the output from the cvcler.) The algorithm is implemented for automatic results determination by analyzing the output Cq with ELITe MGB® software.

The provided text describes the acceptance criteria and the study that proves the performance of the MRSA/SA ELITe MGB® Software, which is a software component of the overall MRSA/SA ELITe MGB® test system. It's important to note that this 510(k) submission (K132468) is specifically for the software that automates the calling algorithm, not the entire diagnostic test kit, which was previously cleared under K112937. Therefore, most performance studies (analytical sensitivity, reactivity, detection limit, reproducibility, carry-over/cross-contamination, clinical studies) are referenced back to the original K112937 submission as they are not affected by the software change.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) (K132468), the primary acceptance criterion is the concordance of results generated by the new automated software with the results generated by the previously cleared manual calling algorithm.

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

The document states, "In accordance with guidance received from FDA in Q120176, the original data from K112937 was recalculated using ELITe MGB software."

• Sample Size for Test Set: The specific sample size used for the recalculation is not explicitly stated in this document but is referred to as "the original data from K112937." To determine the exact sample size, one would need to review the K112937 submission.
• Data Provenance: The data is "original data from K112937," implying it was generated during the studies for the initial clearance of the MRSA/SA ELITe MGB® assay. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective, though diagnostic assay validation studies typically involve prospective collection of samples or a combination of prospective and banked (retrospective) samples.

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

This specific submission (K132468) is evaluating the concordance of software interpretation with a manual interpretation algorithm from K112937, rather than establishing a new ground truth against a clinical "gold standard." Therefore, the concept of "experts establishing ground truth" in the traditional sense doesn't directly apply here. The manual calling algorithm itself represents the established interpretation logic from the previous clearance.

4. Adjudication Method for the Test Set

Not applicable for this type of software validation study. The study involved a direct comparison of algorithmic output with the output of a previously defined manual algorithm. There was no "adjudication" between different human interpretations or human and AI interpretations in this specific study.

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 done for this software submission. The purpose of this submission was to validate the automated software's agreement with the manual algorithm, not to compare human performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this study is inherently a standalone performance evaluation of the algorithm. The software (algorithm) processes the raw data and determines results automatically. The evaluation compares these automated results directly against the results that would have been obtained by applying the manual algorithm from the predicate device's labeling to the same raw data. There is no human "in the loop" performing interpretation for this part of the study; the software automates the interpretation step.

7. The Type of Ground Truth Used

The "ground truth" for this software validation study is the results derived from the manual calling algorithm as described in the labeling of the predicate device (K112937). It's a comparison to an established interpretation method, not directly to pathology, outcomes data, or expert consensus in the typical sense.

8. The Sample Size for the Training Set

The document states, "The development of the software is in compliance with the requirements of the Guidance. The performance of the software has been validated." However, it does not explicitly mention a separate "training set" size for the ELITe MGB® software development. Software for diagnostic devices generally undergoes rigorous development and verification, which might involve internal testing with various data, but the specific size of such an internal training set is not provided here. The critical performance evaluation (concordance) was done on the original data from K112937.

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

Given that a specific "training set" size is not detailed for this software validation, the method for establishing its ground truth is also not elaborated. For the underlying MRSA/SA ELITe MGB® assay (K112937), the ground truth for clinical performance would have been established through methods like confirmatory microbiology cultures, potentially with additional molecular or phenotypic characterization for MRSA distinction, which are standard for such diagnostic tests. The software's "training" (development) would have been guided by the established rules of the manual calling algorithm.

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ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes the regulatory submission for calibration and control devices (ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II) for use with Lipase testing on ELITech Clinical Systems Selectra Analyzers. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance in diagnosing patients.

Therefore, many of the requested points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types related to diagnostic performance of an AI model, are not applicable to this type of device submission.

The "study" referenced in this document is a value assignment and verification process for the calibrator and control materials, not a clinical trial of a diagnostic device.

Here's the information that can be extracted from the provided text, adapted to the context of a calibrator and control material:

1. Table of Acceptance Criteria and Reported Device Performance (for Lipase value assignment):

2. Sample size used for the test set and the data provenance:

• Test Set (for ELICAL 2 Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 and two different approved lot of lipase reagents." The amount of lipase in the "new lot of ELICAL 2" was then measured. The exact number of measurements or samples within this process is not specified, but it involves a comparison against two different approved lots of lipase reagents.
• Test Set (for ELITROL I and ELITROL II Lipase Value Assignment): "The test system" was calibrated using "a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents" and then measuring the amount of lipase in the "new lots of ELITROL I and ELITROL II." The exact number of measurements or samples within this process is not specified but involves a comparison against two different approved lots of lipase test reagents.
• Data Provenance: The data is generated internally by ELITech Clinical Systems as part of their manufacturing and quality control process for calibrators and control materials. No country of origin for the "data" as clinical patient data is provided, as it's a lab-based calibration process. This is a prospective process for each new manufacturing lot.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. The "ground truth" here is the established value of lipase in the calibrator/control material, which is determined through internal procedures and traceability to a titrimetric manual method, not through consensus of human experts interpreting diagnostic results.

4. Adjudication method for the test set:

• Not Applicable. As the "ground truth" is a measured value against a target, there is no expert adjudication involved in the typical sense of interpreting clinical data. The process involves meeting predefined numerical acceptance criteria.

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 not a diagnostic AI device; it's a calibrator/control material. MRMC studies are not relevant here.

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

• Not Applicable. This is not an algorithm or AI device. Its purpose is to ensure the accuracy of laboratory measurements by providing known reference points (calibrators) and quality control materials.

7. The type of ground truth used:

• For ELICAL 2 and ELITROL I/II: The "ground truth" for the lipase values is established through a process traceable to a titrimetric manual method. This serves as the reference standard against which the device's assigned values are verified. The ultimate "ground truth" is therefore a chemical/analytical reference standard.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning or AI device that requires a training set. The "training" of the device is its manufacturing and formulation.

9. How the ground truth for the training set was established:

• Not Applicable. No training set is used. The inherent "ground truth" for the calibrator and control materials is their chemical composition and the established lipase activity, which is then verified against a titrimetric manual method.

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ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELITech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.

ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an aqueous solution ready to use containing bovine albumin at a concentration of 100 mg/dL and sodium azide (

This document describes two devices, a calibrator and a control, for urine total protein measurements. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and expert reviews. Therefore, much of the requested information regarding study design, sample sizes, expert qualifications, and ground truth establishment is not available in these documents.

Here's an attempt to answer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) with specific numerical targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through a comparison of intended use, format, levels, traceability, and stability. The reported "performance" is the equivalence itself.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical or analytical study with a defined sample size for the purpose of primary performance evaluation. The information provided is a premarket notification (510(k)) which aims to demonstrate substantial equivalence to existing legally marketed devices. This typically involves analytical performance data generated by the manufacturer to support the claims, but the specific details of sample sizes for such internal validation studies are not usually included in the public 510(k) summary.

Thus, there is no explicit mention of:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of information is generally relevant for AI/CADe devices where expert consensus or pathological diagnosis establishes ground truth for image interpretation. For a calibrator and a quality control material like these, "ground truth" refers to the accurately assigned values determined through a rigorous measurement process (e.g., gravimetric methods, certified reference materials, reference methods). This is typically established by the manufacturer's internal processes and is overseen by qualified analytical chemists or scientists, not by "experts" in the clinical interpretation sense.

4. Adjudication method for the test set

Not applicable. As there is no "test set" with expert interpretations being adjudicated, this information is not relevant to the provided documentation.

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. MRMC studies are specific to AI/CADe devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The devices described here (calibrator and control) are in vitro diagnostic reagents and do not involve human interpretation in the same way.

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

Not applicable. These are chemical reagents, not algorithms.

7. The type of ground truth used

For the Calibrator: The calibrator is stated to be traceable to SRM 927d (Standard Reference Material 927d). This likely refers to a National Institute of Standards and Technology (NIST) SRM for total protein, which would be the reference method or certified reference material providing the "ground truth" for the calibrator's assigned value.

For the Control: The control is intended for quality control of quantitative methods. The "ground truth" for control materials is typically established by assigned values determined by the manufacturer using validated methods, often relative to reference materials or established laboratory methods. The document also mentions that each urine donation for the control material is "tested individually and found to be negative for HbsAg and antibodies to HCV and HIV-1/HIV-2 according to FDA-approved methods," which contributes to the safety and quality control of the control material itself, rather than establishing a quantitative "ground truth" for a specific analyte measurement.

8. The sample size for the training set

Not applicable. These are not AI/machine learning devices that require a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for these types of devices.

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