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The eSensor® Thrombophila Risk Test is an in vitro diagnostic for the detection and genotyping of Factor II (Prothrombin) G20210A, Factor V (Factor V Leiden) G1691A and MTHFR (human 5, 10 methylenetetrahydrofolate reductase gene) C677T and A1298C mutations with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® FII-FV Genotyping Test is an in vitro diagnostic for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V (Factor V Leiden) G1691A mutations in patients with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® FV Genotyping Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (FV; Coagulation Factor V gene) in patients with suspected thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® FII Genotyping Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210 of the human Factor II gene (FII; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® MTHFR Genotyping Test is an in vitro diagnostic for the detection and genotyping of point mutations (C to T at position 677) and (A to C at position 1298) of the human 5, 10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the eSensor® XT-8 System.

The eSensor® Thrombophila Risk Tests on the eSensor® XT-8 System are in vitro diagnostic devices for performing hybridization and genotyping of multiple mutations and/or polymorphisms in an amplified DNA sample. A single-use, disposable test carridge is used to perform hybridization and genotyping. The cartridge contains an EEPROM chip which transmits the cartridge lot number, expiration date and protocol identity to the XT-8 instrument.

The analysis process for each sample consists of three steps: 1) Genomic DNA isolated from whole blood obtained using EDTA as anti-coagulant is combined with PCR Mix and Taq polymerase enzyme and is subjected to amplification of target sequences by PCR using a thermal cycler. 2) Amplified DNA is treated with exonuclease enzyme to generate single-stranded target DNA. 3) Single-stranded, amplified target DNA is mixed with hybridization and genotyping reagents and transferred to an eSensor® Test cartidge, and the cartridge is inserted in the eSensor® XT-8 Instrument. The instrument controls the circulation of the cartridge to allow hybridization at a controlled temperature and then detects and genotypes the sample by voltammetry.

Genotyping of the test panel polymorphisms is achieved by a sandwich assay principle: 1) Each pair of electrodes contains a different synthetic oligonucleotide capture probe which is complementary to one of the target DNA fragments. 2) The hybridization reagents contain pairs of ferrocene-labeled synthetic oligonucleotide signal probes; one member of each pair is complementary to the major allele sequence of the target polymorphism, while the second member of the pair is complementary to the minor allele sequence. Each member of the probe pair has a ferrocene label with a different oxidation potential for each allele. 3) Single-stranded, amplified target DNA hybridizes to its specific capture probe, and in turn hybridizes to the allele-specific, ferrocene-labeled signal probe. 4) Each electrode of the array is analyzed by voltammetry; the target polymorphism is determined by the location of the electrode containing the capture probe, and the genotype is identified by the ratio of signals from the allele-specific ferrocene labels. The array also includes positive controls to confirm the hybridization reaction and detect non-specific signals.

Upon completion of the test, the EEPROM chip on the cartridge contains information that prevents its re-use with a new sample. The eSensor® XT-8 instrument analyzes the results and provides a report of the test results.

Here's a summary of the acceptance criteria and study details for the eSensor® Thrombophila Risk Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" with numerical thresholds prior to presenting the results. However, the performance characteristics, particularly the "Method Comparison" results, implicitly serve as the primary demonstration of meeting performance expectations against a gold standard. For the reproducibility studies, "100% agreement" strongly implies this as an implicit acceptance criterion for internal consistency.

Note on "Implicit Acceptance Criteria": The document consistently reports 100% (final) agreement with DNA sequencing across all categories in the Method Comparison and 100% correct calls for reproducibility studies. This suggests that achieving perfect or near-perfect agreement with the gold standard (DNA sequencing) and internal consistency was the unstated "acceptance criterion" for these performance studies. The 95% LCB (Lower Confidence Bound) values provided in the method comparison table suggest that the statistical power was sufficient to be confident in these high agreement rates, even with sometimes smaller sample sizes for specific mutation types.

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

• Test Set Sample Size:
  • Method Comparison: 219 gDNA samples.
  • Reproducibility (Inter-laboratory, Inter-operator): 5 gDNA samples run in duplicate each day by each of 6 operators (2 operators per site across 3 sites) over 5 days = 5 x 2 x 3 x 5 = 150 test runs. The table states "Samples Tested: 50" per operator, totaling 300 tests. This implies a set of 5 gDNA samples were tested multiple times.
  • Genomic DNA Extraction Reproducibility: 6 whole blood samples tested with 3 different extraction methods = 18 tests.
  • Lot to Lot Reproducibility: 5 genomic DNA samples tested in duplicates using 3 different kit lots = 30 tests.
  • Limit of Detection: 2 genomic DNA samples, each tested 20 times at 5 different concentrations = 2 x 20 x 5 = 200 tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "3 different sites and 1 internal site" for the reproducibility study, indicating multi-site testing within an unspecified geographic region. The "Method Comparison" study uses "gDNA samples extracted from whole blood," but the origin of these samples is not detailed. All data appears to be prospective in the sense of being generated specifically for these performance studies.

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

• Number of Experts: Not applicable in the traditional sense, as the ground truth was established by DNA sequencing, which is a laboratory method, not human expert consensus.
• Qualifications of Experts: Not applicable. DNA sequencing is a technical standard.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth (DNA sequencing) is considered the definitive standard. Any discrepancies between the eSensor® test and DNA sequencing would be considered an error by the eSensor® test, not a disagreement among experts requiring adjudication. The document mentions "Final Results" after "additional run for a single no-call" in the Lot to Lot study, suggesting a re-run policy for initial "no-calls" rather than adjudication. Similarly, in the method comparison, "Final Results" reflect cases where initial "no-calls" were resolved, making the "Final Agreement" 100%.

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

• No, an MRMC comparative effectiveness study was not done. This device is a molecular diagnostic test for genotyping, not an imaging diagnostic requiring interpretation by human readers. Therefore, the concept of human readers improving with AI assistance does not apply here.

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

• Yes, a standalone performance study was done. This entire submission focuses on the performance of the eSensor® system (instrument + assay kits) as a standalone diagnostic device. The results are compared directly against DNA sequencing (the gold standard), and the system provides results without real-time human interpretation for genotype determination. Human intervention is limited to sample preparation, loading, and reviewing the automatically generated report.

7. The Type of Ground Truth Used

• The type of ground truth used was DNA sequencing. This is explicitly stated across various sections, most notably under "Genomic DNA Extraction Reproducibility," "Lot to Lot Reproducibility," and "Method Comparison" where "All samples gave 100% correct calls when compared with DNA sequencing."

8. The Sample Size for the Training Set

• The document does not explicitly state a separate "training set" or its sample size. Diagnostic kits like this, especially those based on hybridization and electrochemical detection principles for known mutations, are typically developed and optimized during an R&D phase, and then validated with the performance studies presented. There isn't typically a distinct "training set" in the same way machine learning algorithms have. The pre-market submission focuses on the validation of the finalized device.

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

• Since a separate "training set" is not explicitly mentioned or detailed, the method for establishing ground truth for such a set is also not described. If an internal training or optimization phase utilized samples, it can be inferred that DNA sequencing would have been the likely method for establishing their ground truth, consistent with the validation studies.

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The eSensor® CF Genotyping Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG). The eSensor® CF Genotyping Test is a qualitative genotyping test that provides information intended to be used for cystic fibrosis carrier screening as recommended by ACMG and the 2005 American College of Obstetricians and Gynecologists (ACOG) for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children. The test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes and results should be used in conjunction with other available laboratory and clinical information.

The eSensor® CF Genotyping Test is intended for use on the eSensor® XT-8 System.

The eSensor® CF Genotyping Test on the eSensor® XT-8 System is an in vitro diagnostic device for performing hybridization and genotyping of multiple mutations and/or polymorphisms in an amplified DNA sample. A single-use, disposable test cartridge is used to perform hybridization and genotyping. The cartridge contains an EEPROM chip which transmits the cartridge lot number, expiration date and protocol identity to the XT-8 instrument.

The analysis process for each sample consists of three steps: 1) Genomic DNA isolated from whole blood obtained using EDTA as anti-coagulant is combined with PCR Mix and Taq polymerase enzyme and is subjected to amplification of target sequences by PCR using a thermal cycler. 2) Amplified DNA is treated with exomuclease enzyme to generate single-stranded target DNA. 3) Single-stranded, amplified target DNA is mixed with hybridization and genotyping reagents and transferred to an eSensor® CF Genotyping Tet cartinge, and the cartridge is inserted in the eSensor® XT-8 Instrument controls the circulation of the sample inside the cartridge to allow hybridization at a controlled temperature and then detects and genotypes the sample by voltammetry.

Genotyping of the test panel polymorphisms is achieved by a sandwich assay principle: 1) Each pair of electrodes contains a different synthetic oligonucleotide capture probe which is complementary to one of the target DNA fragments. 2) The hybridization reagents contain pairs of ferrocenc-labeled synthetic oligonucleotide signal probes; one member of each pair is complementary to the major allele sequence of the target polymorphism, while the second member of the pair is complementary to the minor allele sequence. Each member of the probe pair has a ferrocene label with a different oxidation potential for each allele. 3) Single-stranded, amplificd target DNA hybridizes to its specific capture probe, and in turn hybridizes to the allele-specific, ferrocenc-labeled signal probe. 4) Each electrode of the array is analyzed by voltammetry; the target polymorphism is determined by the location of the electrode containing the capture probe, and the genotype is identified by the ratio of signals from the allclespecific ferrocene labels. The array also includes positive and negative confirm the hybridization reaction and detect non-specific signals.

Upon completion of the test, the EEPROM chip on the cartridge contains information that prevents its re-use with a new sample. The eSensor® XT-8 instrument analyzes the results and provides a report of the test results.

The eSensor® CF Genotyping Test on the XT-8 System is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the successful demonstration of 100% agreement with DNA sequencing after repeat testing for initial no-calls across various studies. The primary performance metric is the agreement with the gold standard (DNA sequencing).

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Reproducibility Study: 22 gDNA samples containing positive calls for all ACOG/ACMG panel mutations and the 5/7/9T polymorphism. Each sample was run in duplicate, generating 1320 total replicates across multiple sites and operators.
  • Lot-to-Lot Reproducibility: 21 genomic DNA samples covering all possible genotypes.
  • Genomic DNA Extraction Reproducibility: 20 whole blood samples of different genotypes.
  • Method Comparison: 112 gDNA samples extracted from whole blood.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a diagnostic test, it is highly likely that samples were collected prospectively or obtained from biobanks with appropriate ethical approvals, and the studies were conducted in a controlled, prospective manner to validate device performance. The reproducibility study involved an "Internal Site" and "External Sites," suggesting multi-center data collection, likely within the USA where the manufacturer is located.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established using DNA sequencing, which is a widely accepted gold standard in genetic testing. The interpretation of DNA sequencing results for CFTR mutations is a specialized task typically performed by molecular geneticists or clinical laboratory directors with expertise in sequencing analysis.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). Instead, discrepancies (initial "no-calls") in the device's output were resolved by re-running the tests, leading to "Final Correct Calls." Miscalls were not observed.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is an automated genotyping test, not an imaging device that would typically involve human readers for interpretation. The comparison is between the automated device's output and the established DNA sequencing results, and not aimed at quantifying human reader improvement with AI assistance.

6. Standalone Performance

Yes, standalone performance (algorithm only without human-in-the-loop) was performed. The eSensor® CF Genotyping Test is an automated system that provides results via a software program on the eSensor® XT-8 instrument. The performance data presented (reproducibility, method comparison, limit of detection, interfering substances) all reflect the standalone analytical performance of the device without explicit human intervention in the result interpretation process (beyond standard laboratory procedures for running the test and reviewing the final report).

7. Type of Ground Truth Used

The type of ground truth used was DNA sequencing. This is explicitly stated as the reference method for comparison throughout the performance characteristics section (e.g., "All samples gave 100% correct calls when compared with DNA sequencing," and "All samples gave 100% agreement with DNA sequencing").

8. Sample Size for the Training Set

The document does not specify a separate training set size for the device's development or algorithm. This is common for predicate-based 510(k) submissions of in vitro diagnostic devices where the focus is on analytical and clinical validation of the final product, rather than the development process of a machine learning algorithm that typically requires a distinct training phase. The device uses established electrochemical detection technology and a predefined panel of mutations, not a learning algorithm that would necessitate a large training dataset as seen in modern AI/ML submissions.

9. How Ground Truth for the Training Set Was Established

As no separate training set is explicitly mentioned or seems applicable in the context of this device's technology, the method for establishing ground truth for a training set is not provided. The development of the device likely relied on established scientific knowledge of CFTR mutations and electrochemical detection principles, rather than an iterative machine learning training process. The validation studies (using DNA sequencing as ground truth) confirm the performance of the final device.

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The eSensor® Warfarin Sensitivity Test is an in vitro diagnostic for the detection and genotyping of the *2 and * 3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from fresh whole blood samples preserved with EDTA, as an aid in the identification of patients at risk for increased warfarin sensitivity. The eSensor® Warfarin Sensitivity Test is for Rx only professional use within the confines of a licensed laboratory, as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
The eSensor® XT-8 Instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.

The eSensor® XT-8 System is an in vitro diagnostic device for performing hybridization and genotyping of multiple mutations and/or polymorphisms in an amplified DNA sample. The XT-8 Instrument is configured with one to three processing towers which perform up to 8 simultaneous tests per tower. The XT-8 System uses a single-use, disposable test cartridge to perform hybridization and genotyping in approximately 30 minutes per sample. The cartridge contains an EEPROM chip which transmits the cartridge lot number, expiration date and protocol identity to the instrument.
The analysis process for each sample consists of three steps: 1) Genomic DNA isolated from whole blood obtained using EDTA as anti-coagulant is combined with PCR Mix and Taq polymerase enzyme and is subjected to amplification of target sequences by PCR using a thermal cycler. 2) Amplified DNA is treated with exonuclease enzyme to generate single-stranded target DNA. 3) Single-stranded, amplified target DNA is mixed with hybridization and genotyping reagents and transferred to an eSensor® Warfarin Sensitivity Test cartridge, and the cartridge is inserted in the eSensor® XT-8 Instrument. The instrument controls the circulation of the sample inside the cartridge containing to allow hybridization at a controlled temperature, and then detects and genotypes the sample by voltammetry.
Genotyping of the test panel polymorphisms is achieved by a sandwich assay principle: 1) Each pair of electrodes contains a different synthetic oligonucleotide capture probe which is complementary to one of the target DNA fragments. 2) The hybridization reagents contain pairs of ferrocene-labeled synthetic oligonucleotide signal probes; one member of each pair is complementary to the major allele sequence of the target polymorphism, while the second member of the pair is complementary to the minor allele sequence. Each member of the probe pair has a ferrocene label with a different oxidation potential for each allele. 3) Single-stranded, amplified target DNA hybridizes to its specific capture probe, and in turn hybridizes to the allele-specific, ferrocene-labeled signal probe. 4) Each electrode of the array is analyzed by voltammetry; the target polymorphism is determined by the location of the electrode containing the capture probe, and the genotype is identified by the ratio of signals from the allele-specific ferrocene labels. The array also includes positive and negative controls to confirm the hybridization reaction and detect non-specific signals.
Upon completion of the test, the EEPROM chip on the cartridge contains information that prevents its re-use with a new sample. The instrument analyzes the results and provides a report of the test results. The operator removes the used cartridge from the slot of the XT-8 Instrument, and that slot is ready to accept a new test.

Here's a breakdown of the acceptance criteria and the study details for the eSensor® Warfarin Sensitivity Test and XT-8 System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Reproducibility Study Test Set:

     • Samples: 5 genomic DNA samples covering all possible genotypes for the three alleles (CYP2C92, CYP2C93, VKORC1).
     • Total Tests: 200 tests for each allele (CYP2C92, CYP2C93, VKORC1), for a grand total of 600 allele tests in the final analysis (5 samples * 4 operators/sites * 5 days * 2 runs per day = 200 tests per allele for an operator who performed 2 runs a day).
     • Data Provenance: Three sites were used: one internal (likely Osmetech Molecular Diagnostics) and two external. The country of origin is not specified, but given the submission is to the FDA, it is likely US-based or recognized for regulatory purposes. The study appears prospective, as it involves controlled testing of specific samples under varied conditions.

   • Genomic DNA Extraction Reproducibility Test Set:

     • Samples: 7 whole blood samples of different genotypes.
     • Total Tests: 21 tests for each allele per site (7 samples * 3 replicates). With 3 sites, this totals 63 tests per allele, and 189 allele tests overall.
     • Data Provenance: Three different sites, using different commercially available extraction methods. Similar to the above, country of origin is not specified but likely US-based, and the study is prospective.

   • Method Comparison Test Set:

     • Samples: 157 samples.
     • Total Tests: 157 samples tested on the eSensor device; 157 samples tested by DNA sequencing. On a per-SNP basis, this represents 471 data points (157 samples * 3 SNPs).
     • Data Provenance: Not explicitly stated, but implies collected samples for method comparison. The nature (retrospective/prospective) isn't directly stated, but typically, method comparison studies utilize a representative set of existing or collected samples in a controlled manner, making them essentially prospective for the purpose of the comparison.

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

   • The ground truth for all studies (reproducibility and method comparison) was established by DNA sequencing. The document does not specify the number of experts or their qualifications for interpreting the DNA sequencing results. DNA sequencing is generally considered a highly accurate gold standard for genotyping, and its interpretation often involves trained molecular biologists or geneticists, but no specific details are provided here.

3. Adjudication method for the test set:

   • No formal adjudication method (like 2+1, 3+1 consensus) is explicitly mentioned for the test set.
   • For the reproducibility study, "An additional run using the same kit lot and sample as for the first-pass test were performed for test that gave a no-call result." This implies a re-testing/re-run strategy for initial failures rather than human expert adjudication of output discrepancies. All no-calls were resolved to 100% agreement after additional runs.
   • For the method comparison and extraction reproducibility, there were no initial no-calls or incorrect calls, so no adjudication or re-testing was necessary beyond the initial DNA sequencing ground truth.

4. 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 MRMC comparative effectiveness study was performed or described. This device is an in vitro diagnostic for genotyping, meaning it produces a direct genetic result, and there is no "human reader" analogue in the typical sense of interpreting imaging or complex clinical data where AI assistance would be measured. The output is a genotype, which is then used by medical professionals.

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

   • Yes, the performance studies (reproducibility, extraction reproducibility, and method comparison) represent the standalone performance of the eSensor® Warfarin Sensitivity Test and XT-8 System. The device analyzes DNA samples and outputs a genotype. While human operators perform PCR and load samples, the critical genotyping step and result interpretation are performed by the instrument's software ("Assay signal results are interpreted by a software program and are assigned a genotype that is presented to the end-user in a report format"). The 100% agreement with DNA sequencing demonstrates this algorithmic performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used for all performance studies was bi-directional DNA sequencing. This is considered a highly reliable molecular diagnostic method.

7. The sample size for the training set:

   • The document does not specify a separate "training set" or its size. As an in vitro diagnostic device, particularly for genetic testing, the development process generally involves analytical validation (like the studies described) rather than a machine learning training phase analogous to image analysis AI. The device's underlying "algorithm" is based on biochemical reactions and electrochemical detection, not a learned model from a dataset.

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

   • Since no training set is explicitly mentioned in the context of machine learning, there's no ground truth establishment for such a set described. The "knowledge" or parameters for the device's operation would have been developed through biochemical and engineering principles, with validation done against known standards (DNA sequencing) as detailed in the performance studies.

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The Osmetech OPTI R Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, total hemoglobin content and oxygen saturation in sample of whole blood, serum or plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The OPTI R Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in., 10 lbs], microprocessor-based instrument using optical fluorescence for the measurement of pH, pCO2, PO2, sodium, potassium and ionized calcium in samples of whole blood, plasma or serum. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A multiple use cassette provides up to 50 patient and 42 aqueous quality control samples on a single cassette during a seven day period. The sample count and time is maintained by the analyzer and reported to the user with each sample operation. The cassette contains six optical fluorescence sensors and is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. One of these sensors, the oxygen sensor, is also used for the simultaneous measurements of ctHb and SO2. This bar code is read by 'swiping' the foil pouch through a bar code reader conveniently located on the right side of the OPTI R instrument. This bar coded information is used for a calibration verification of the cassette prior to sample introduction. The cassette is then removed from the pouch and placed into the measuring chamber of the OPTI R and a light-tight cover is closed and secured. The OPTI R performs a calibration as needed, but minimally every 30 minutes or within 30 minutes of every patient's sample utilizing liquid buffer and precision calibration gas, both of which are maintained within the analyzer. The buffer is contained in the OPTI R Fluid Pack and the precision gas is contained in a cylinder. Various checks of mechanical and calibration integrity are performed during this calibration to ensure correct operation and measurement. The OPTI R aspirates the specimen into the cassette either from a capillary tube, syringe or Osmetech ComfortSampler™, and into position over the fluorescence sensors for pH, PCO2, PO2, Na , K , and iCa " as well as ctHb and SO2. During this process, additional checks are made for position and integrity of the sample, measurement stability, and end-point. After the results are displayed and printed the sample is moved to the waste pouch contained within the OPTI R Fluid Pack. The cassette is then rinsed and calibrated, after which the cassette is ready for the next sample. Communication to the device is accomplished simply with the use of a touch screen graphical user interface. The analyzer communicates to the user through a color display and with a thermal printer using heat sensitive paper to output measured values, calibration reports, and other information. The data from the analyzer may be communicated to hospital HIS/LIS data systems through an RS232 output terminal.

The provided 510(k) summary for the Osmetech OPTI R Critical Care Analyzer does not contain detailed acceptance criteria and study results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device (K000103) by highlighting similarities in intended use, operating principle, basic design, materials, and packaging.

The summary states that "Analysis of the data collected during verification and validation testing including linearity and precision testing for this device demonstrates that the Osmetech OPTI R Critical Care Analyzer is safe, effective, and equivalent to predicate device [K000103] to which it is compared. The key design verification tests that were performed as a result of the risk analysis are listed under the tab, Verification and Validation."

However, the specific "Verification and Validation" tab content, which would detail acceptance criteria and reported device performance for each parameter (pH, PCO2, PO2, Na+, K+, iCa++, ctHb, SO2), sample sizes, data provenance, ground truth establishment, and the other requested information, is not included in this public 510(k) summary.

Therefore, based solely on the provided text, I cannot complete the requested tables and sections. The document indicates that such testing was performed, but it does not present the results or methodology in detail within the provided extract.

To address your request, if the full "Verification and Validation" report were available, the information would typically be extracted and presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. Typically, for such a device, samples would be clinical specimens (whole blood, plasma, or serum) drawn from a diverse patient population, likely from a clinical laboratory or point-of-care settings. It is presumed to be prospective collection for validation, but this is not explicitly stated.

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

This type of information is generally not applicable to an in vitro diagnostic (IVD) device like a critical care analyzer. The "ground truth" for quantitative measurements like pH, blood gases, or electrolytes is established by reference methods or validated comparative analyzers, not by human expert consensus or radiologists.

4. Adjudication method for the test set

Not applicable for a quantitative IVD device measuring objective parameters.

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 device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system. It directly measures physiological parameters.

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

Yes, this is an inherent aspect of an automated IVD analyzer. The device itself performs the measurements and provides results without direct human interpretive input for each measurement. The validation testing (linearity, precision, method comparison) would be a standalone evaluation of the device's analytical performance.

7. The type of ground truth used

For an IVD device measuring physiological parameters, the ground truth is typically established by:

• Reference methods: Highly accurate and precise laboratory methods, often using different principles, considered the gold standard for that analyte.
• Method comparison: Comparing the device's results against a legally marketed, predicate, or established clinical laboratory analyzer using patient samples. The predicate device (K000103) itself would likely have been validated against such methods.

8. The sample size for the training set

Not applicable. This device is not described as involving a machine learning or AI component that would require a separate "training set" in the conventional sense (e.g., for image recognition or predictive models). The device is a direct measurement instrument. Calibration and internal quality control procedures are utilized but not typically referred to as a "training set."

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

Not applicable, as there is no "training set" in the context of machine learning for this device. Calibration is performed using liquid buffers and precision calibration gas, with integrity checks. These calibrated materials serve as known standards for the device's measurement system.

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The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface.

The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.

The Osmetech OPTI LION Electrolyte Analyzer is a medical device intended for the measurement of pH, sodium, potassium, ionized calcium, and chloride in whole blood, serum, plasma, and aqueous controls. The following information details the acceptance criteria and the study that proves the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for each analyte. Instead, it refers to the "medically allowable errors as defined in CLIA'88 performance standards" as the benchmark for comparison. The study's conclusion is that the device's performance is acceptable against these standards.

Without specific numerical acceptance criteria from the document, we can infer the performance metrics reported as evidence of meeting an unspecified acceptable level based on CLIA'88 standards.

2. Sample Size for the Test Set and Data Provenance

The document states: "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and plasma or serum collected for routine analysis on existing instrumentation." This indicates the data provenance is retrospective, using pre-existing patient samples. The country of origin of the data is not specified, but the applicant company is based in Roswell, GA, USA.

The exact sample size for the test set is not explicitly stated in the provided text.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance of the OPTI LION Electrolyte Analyzer was correlated against "predicate devices" in a clinical setting. This implies the "ground truth" was established by measurements from these predicate devices.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned. The comparison was made against predicate devices, which likely involved direct comparison of numerical results.

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. The study focused on comparing the device's performance against predicate devices, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The "clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices." This implies that the device (algorithm only, as it's an automated analyzer) was run on samples and its results were compared to those of existing predicate devices. The operation by "personnel minimally qualified to perform and report these results" indicates a human-in-the-loop for operation, but the performance being assessed is that of the analyzer itself.

7. The Type of Ground Truth Used

The ground truth used was established by measurements obtained from predicate devices. The document states, "Clinical testing was conducted to demonstrate the correlation of Osmetech OPTI LION Electrolyte Analyzer to predicate devices in a clinical setting." The "predicted systematic differences and their 95% confidence intervals between the OPTI LION and the predicated devices" were then compared to CLIA'88 performance standards.

8. The Sample Size for the Training Set

The document focuses on the validation of the device and does not provide information about a "training set" in the context of machine learning or AI models. This device is an analyzer that uses optical fluorescence and factory-calibrated cassettes, rather than an AI model that undergoes a training phase with a specific dataset. Therefore, the concept of a training set as typically understood for AI algorithms does not apply here, and no sample size for a training set is provided.

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

Given that the device is an analyzer based on optical fluorescence and factory-calibrated cassettes, it does not have a "training set" in the AI sense. Its calibration is performed during manufacturing, and each cassette contains bar-coded calibration information.

The description of calibration states: "Each lot of OPTI LION cassettes is calibrated during the manufacturing process... The OPTI LION system uses a proprietary dry calibration process... This dry-to-wet (mid-physiologic) relationship is stable and consistent for all sensors in a lot, and is characterized and bar-coded at the factory. In addition, the sensor's wet response curve of the fluorescent intensity versus analyte level is factory-characterized and bar-coded."

Therefore, the "ground truth" for the device's operational parameters (akin to a training phase in AI) is established through factory characterization and calibration based on known concentrations of analytes and the relationship between dry and wet fluorescent intensities. This is an engineered calibration rather than a data-driven training process with human-established ground truth.

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The Osmetech Microbial Analyzer-Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use to indirectly measure bacterial presence by semi-quantitative analysis of volatile compounds released into the headspace above a high vaginal swab. The OMA™-BV is indicated for use as an adjunct for the diagnosis of Bacterial vaginosis (BV). The device may be used together with other clinical and patient information when diagnosing BV including pH, vaginal discharge characteristics, amine odor and clue cells or gram stain procedures that are currently commonly used to diagnose infection.

The OMA™-BV uses "electronic nose" technology for the detection of volatile compounds released from microorganisms in human specimens. The principle is based on the release of volatile compounds from bacteria into the headspace [the volume above the High Vaginal Swab (HVS) samples] of clinical samples. The volatile compounds are detected by an array of gas sensors based on patented conducting polymer technology.

Acceptance Criteria and Study for Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™-BV)

The Osmetech Microbial Analyser™ - Bacterial Vaginosis (OMA™-BV) is an automated in vitro diagnostic device intended for use as an adjunct for the diagnosis of Bacterial Vaginosis (BV).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% agreement"). Instead, it reports the observed performance in comparison to established clinical methods. The implicit acceptance is based on demonstrating comparable or better agreement than existing comparisons between those clinical methods themselves.

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

• Sample Size: Not explicitly stated as a single number for the entire test set. The percentages reported are based on a "multi-center clinical trial of subjects with suspected BV."
• Data Provenance: Prospective, multi-center clinical trial conducted in the U.S. and the U.K.

3. 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 specific qualifications (e.g., radiologist with X years of experience). However, it references established clinical procedures for BV diagnosis:

• Amsel criteria
• Nugent scoring system (Gram stain procedures)
• Clinical diagnosis (presumably by clinicians/physicians)

This implies that the "ground truth" was established by multiple clinical professionals utilizing these standard diagnostic methods. Their specific qualifications are not detailed beyond "clinicians" for "clinical diagnosis" and presumably laboratory personnel and clinicians for Nugent scoring and Amsel criteria.

4. Adjudication Method for the Test Set

The document does not specify a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in the ground truth. It states that the OMA™-BV was compared to "the combination of three clinical procedures commonly used to diagnose BV (the Nugent scoring system, Amsel criteria, and clinical diagnosis)." This suggests that each of these methods independently contributed to the comparative dataset, but the process for combining or adjudicating their results to form a single "ground truth" for each patient is not detailed. It relies on the existing clinical consensus of these combined methods lacking a single "gold standard."

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study compared the OMA™-BV device performance to established clinical procedures rather than directly comparing human readers with and without AI assistance.

• Effect Size: Not applicable, as an MRMC study was not described.

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

Yes, the described clinical trial evaluated the standalone performance of the OMA™-BV device. The device generated its results independently, which were then compared against the results from the established clinical diagnostic methods. The device is intended as an adjunct, meaning it works with human clinicians, but the performance data presented is the device's direct agreement with the clinical standards.

7. The Type of Ground Truth Used

The type of ground truth used was a composite clinical diagnosis/expert consensus, based on established clinical procedures for BV diagnosis. Specifically, it was determined by the "combination of three clinical procedures commonly used to diagnose BV (the Nugent scoring system, Amsel criteria, and clinical diagnosis)." The document explicitly states, "Since there is no "gold standard" for diagnosis of BV, agreement between current clinical procedures and the OMA™-BV device results was used to compare BV diagnostic methods."

8. The Sample Size for the Training Set

The document does not specify a separate sample size for a training set. The clinical trial data reported appears to be the primary performance evaluation. While "the detection threshold of the BV device has been set to detect levels of volatile metabolites found in specimens associated with BV, as demonstrated in a multi-center clinical trial," this might imply some forms of internal calibration or development against a dataset, but a distinct "training set" in the context of machine learning model development (as might be expected for an AI device today) is not provided.

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

As a separate training set is not explicitly mentioned, the method for establishing its ground truth is also not detailed. Any internal development or calibration would have presumably relied on similar clinical diagnostic methods (Nugent, Amsel, clinical diagnosis) to determine the "levels of volatile metabolites found in specimens associated with BV."

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