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The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.

Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.

The Lyra RSV + hMPV Assay can be performed using ether the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.

The Lyra RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® or NucliSENS® EMAG® automated extraction platform. A multiplex RT-PCR reaction is then performed in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II, the Applied Biosystems 7500 Fast DX, or the Life Technologies QuantStudio" Dx. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.

The acceptance criteria and the study proving the device meets these criteria for the Lyra RSV + hMPV Assay are detailed below. It's important to note that the provided documents primarily describe a change to an existing device (the addition of a new extraction platform, BioMerieux NucliSENS EMAG) and compare its performance to the previously cleared predicate device. Therefore, the "acceptance criteria" and "reported device performance" are framed around this equivalency.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the information provided, the overall acceptance criterion is equivalent performance of the modified Lyra RSV + hMPV Assay (with the new extraction platform) to the predicate device (Quidel RSV+hMPV Assay using the original extraction platform). The performance is assessed through "non-clinical and clinical verification and validation activities."

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

The exact sample sizes for the "Limit of Detection Equivalency Study" and "Clinical Equivalence Study" are not explicitly stated in the provided 510(k) summary.

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The nature of "clinical equivalence study" typically implies prospective or retrospectively collected clinical samples, but details are lacking.

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

This information is not provided in the given text. For a PCR-based assay like this, ground truth is typically established using a highly sensitive and specific reference method (e.g., another validated PCR assay or sequencing), rather than expert clinical consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Given that this is a molecular diagnostic assay, adjudication methods like N+1 for expert review (common in imaging studies) are generally not applicable. Instead, the "ground truth" would be determined by the reference method itself.

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 primarily relevant for medical imaging interpretation where different human readers interpret cases, often with and without AI assistance. This device is a molecular diagnostic assay (RT-PCR) and does not involve human interpretation of complex images in the same way.

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

Yes, implicitly. The device itself is an in vitro diagnostic test, specifically a Real-Time PCR assay. Its performance (qualitative detection of RNA) is inherently "standalone" as it produces a result without direct human interpretive input during the assay itself. The studies ("Limit of Detection Equivalency Study" and "Clinical Equivalence Study") would evaluate the accuracy of the assay's output against a reference method, which is a standalone performance assessment.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated but can be inferred to be a highly reliable reference method, likely another validated molecular diagnostic test (e.g., gold standard PCR assay or culture/sequencing) for detecting RSV and hMPV. For Limit of Detection studies, ground truth would be established by precisely quantifying viral RNA in samples.

8. The Sample Size for the Training Set

This information is not applicable in the context of this device. The Lyra RSV + hMPV Assay is a Real-Time PCR assay, which is a biochemical reaction-based test, not an AI/Machine Learning algorithm that requires a "training set" in the traditional sense. The "training" for such an assay involves optimization of reagents, primers, probes, and reaction conditions.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device. The development of the assay involves establishing analytical ground truth through various laboratory experiments to ensure the primers and probes are specific and sensitive to the target viruses, and that the internal control functions correctly.

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The Lyra Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and endemiological risk factors. The assay does not detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The assay can be performed using either the Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx or the Cepheid SmartCycler II.

The Lyra Influenza A+B Assay detects viral RNA that have been extracted from a patient sample using the NucliSENS easyMAG or EMAG automated extraction platform. A multiplex RT-PCR is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid® SmartCycler® II. Identification of influenza A occurs by the use of target specific primers and a fluorescent-labeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.

The provided text describes a 510(k) premarket notification for the Lyra Influenza A+B Assay. The notification primarily focuses on a modification to the device, specifically the inclusion of a new nucleic acid extraction platform (BioMerieux NucliSENS EMAG) while maintaining the original intended use and other core functionalities.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met." However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) are not detailed in the provided text. Similarly, the specific quantitative reported device performance metrics (e.g., exact sensitivity and specificity values) from the studies are not presented in the provided summary.

The summary only states: "Non-clinical and clinical verification activities conducted with the Lyra Influenza A+B Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."

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

The text mentions a "Clinical Equivalency Study" but does not provide details on the sample size used for its test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set.

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

The text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on the performance of the assay itself, not human reader improvement with/without AI assistance.

6. Standalone Performance Study

The studies mentioned ("Limit of Detection Equivalency Study" and "Clinical Equivalency Study") describe the performance of the device (algorithm/assay only), implying a standalone performance evaluation. However, the text does not explicitly use the term "standalone" or specify that it was "algorithm only without human-in-the-loop performance." Given that it's an RT-PCR assay, its performance by definition is standalone.

7. Type of Ground Truth Used

The text does not explicitly state the type of ground truth used for the clinical equivalency study. For diagnostic assays like this, ground truth is typically established through a combination of:

• Confirmatory laboratory methods (e.g., viral culture, another highly sensitive and specific PCR method, or sequencing as a gold standard).
• Clinical diagnosis by a physician.

However, this information is not provided.

8. Sample Size for the Training Set

The text does not provide information on a training set sample size. This is a modification to an existing assay, and the studies mentioned are verification/validation studies for the modification, not development studies for a new algorithm that would typically involve a separate training set.

9. How Ground Truth for the Training Set was Established

Since no training set information is provided, there is no information on how its ground truth was established.

Summary of Missing Information:

A significant amount of detail regarding the studies, particularly the quantitative acceptance criteria, reported performance, sample sizes, and ground truth methodologies, is not present in the provided FDA 510(k) summary letter. The letter serves as an approval notification and summary of the device's substantial equivalence, focusing on the change (new extraction platform) rather than a comprehensive, detailed clinical study report.

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The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE includes all ages.

The Lyra with TEOAE is intended for use in the audiologic evaluation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages.

The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

The device is audiometric equipment used for assisting of inner ear abnormalities. Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. The PC software provides a user interface designed to integrate in the standard Microsoft Windows environment. Lyra can be purchased with various licenses allowing you to perform different hearing screening tests.

Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.

Transient otoacoustic emissions (TEOAE) technology uses a short duration stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.

The provided text describes a 510(k) premarket notification for an audiometric device named Lyra. The submission asserts the substantial equivalence of the Lyra device to legally marketed predicate devices (Titan™ TEOAE and Titan™ DPOAE).

However, the documentation does not contain information related to acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established beyond general statements about design verification and validation against standards.

The document primarily focuses on establishing substantial equivalence based on:

• Identical Indications for Use: Both Lyra and the predicate devices are intended for audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions (DPOAE) and Transient Evoked Otoacoustic Emissions (TEOAE) for all ages, to be used by trained personnel.
• Similar Technological Characteristics: The document provides detailed comparison tables highlighting that Lyra shares virtually all key technological characteristics (e.g., type, regulation number, product code, target population, intended user, anatomical sites, safety and performance standards, device type, system configuration, stimulus types, frequency ranges, levels, level steps, transducer, probe detection, recording, A/D resolution, artifact reject system, automatic test with display of PASS-REFER) with the predicate devices.
• Non-Clinical Testing Summary: It states that design verification and validation were performed according to current standards (IEC 60601-1 series, IEC 60645 series) to assure the device meets performance specifications, and software verification and validation were conducted.
• Clinical Testing Summary: Crucially, it states "Not applicable. Not required to establish substantial equivalence."

Therefore, based on the provided text, I cannot complete the requested tables and information. The submission for the Lyra device explicitly states that clinical testing was "Not applicable" and "Not required to establish substantial equivalence," meaning the detailed study design elements you requested (like acceptance criteria for performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies) were not part of this 510(k) submission.

The acceptance criteria for this submission appear to be demonstrating equivalence to established predicate devices through non-clinical performance and technological characteristics, rather than demonstrating a specific level of clinical performance against a clinical ground truth.

In summary, the provided document does not support the specific type of performance study you are asking about, as it relies on substantial equivalence to predicates rather than novel clinical performance demonstration.

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The Lyra™ Parainfluenza Virus Assay is a Real-Time PCR assay for the qualitative detection and identification of human parainfluenza virus types 1, 2 and 3 viral RNA from nasal and nasopharyngeal swab specimens from symptomatic patients. It is intended for use as an aid in the differential diagnosis of parainfluenza virus types 1, 2 and 3. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b viruses.

Negative results do not preclude parainfluenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

The Lyra™ Parainfluenza Virus Assay is a Real-Time PCR assay for the qualitative detection and identification of human parainfluenza virus types 1, 2 and 3 viral RNA from nasal and nasopharyngeal swab specimens from symptomatic patients. The assay detects viral nucleic acids that have been extracted from a patient sample. A multiplex Real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for PIV-1, PIV-2, PIV-3 and the Process Control (PRC). Identification of PIV-1, PIV-2, PIV-3 and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of PIV-1. PIV-2. PIV-3 and the PRC.

Here's a summary of the acceptance criteria and study details for the Lyra™ Parainfluenza Virus Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity or specificity. However, based on the conclusions regarding "good sensitivity and specificity" and "good positive and negative percent agreement," we can infer the expected performance. The reported performance is presented below:

2. Sample Size for Test Set and Data Provenance

• Prospective Study:
  • Sample Size: 1241 fresh upper respiratory tract specimens.
  • Data Provenance: Not explicitly stated, but the "Prospective multi-center study" suggests samples were collected from various clinical sites. The specimens were sent to a "central location" for comparative testing, implying multi-site collection.
  • Retrospective Study:
  • Sample Size: 105 frozen upper respiratory tract specimens.
  • Data Provenance: Specimens "obtained from a pediatric hospital in the Southwest United States."

3. Number of Experts and Qualifications for Ground Truth

• Prospective Study: The ground truth was established using "direct specimen fluorescent antibody (DSFA) and cell culture with DFA (CCFA)." The document does not specify the number or qualifications of experts involved in performing or interpreting these reference methods.
• Retrospective Study: The ground truth was established using a legally marketed predicate device, the "Prodesse ProParaFlu+ assay (K091053)." The document does not mention experts establishing this ground truth, as it's a comparison against another device.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test sets. For discrepant results in the prospective study, an "additional RT-PCR assay" was used for a subset of samples (e.g., 2 of 3 PIV-1 false positives, all 5 PIV-3 false positives). Similarly, for the retrospective study, an "additional RT-PCR assay" was used for 1 PIV-1 false positive and all 5 PIV-2 false positives. This implies a reference method approach, potentially with further molecular confirmation for outliers.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document describes a standalone performance study of the device against reference methods and another legally marketed device; it does not involve human readers or assess improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The Lyra™ Parainfluenza Virus Assay, a Real-Time PCR assay (an algorithm-based diagnostic test, not requiring human interpretation of output beyond reading the results), was evaluated on its own against established reference methods (DSFA and CCFA in the prospective study, and the Prodesse ProParaFlu+ assay in the retrospective study).

7. Type of Ground Truth Used

• Prospective Study: Expert consensus, specifically a composite reference method of direct specimen fluorescent antibody (DSFA) and cell culture with DFA (CCFA).
• Retrospective Study: A legally marketed predicate device (Prodesse ProParaFlu+ assay).

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is a diagnostic assay, and the studies described are performance evaluations, not specifically machine learning model training. The assay's design would have involved internal development and analytical verification, but the term "training set" as commonly used for machine learning is not applicable or detailed here.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" is described in the context of machine learning, this information is not provided. The development of the assay would have been based on established molecular biology principles and analytical validation using known positive and negative controls/samples.

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The Lyra™ Adenovirus Assay is a real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal and nasopharyngeal swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infections. The intended use of this test is to aid in the diagnosis of HAdV in conjunction with other clinical and laboratory findings.

The test detects, but does not differentiate. HAdV species (A, B, C, D, E, and F) or serotypes (HAdV 1-52).

Negative results do not preclude HAdV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

The Lyra™ Adenovirus Assay is a real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal and nasopharyngeal swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infections. The assay detects viral nucleic acids that have been extracted from a patient sample. A real-time PCR reaction is carried out using the ABI 7500 Fast Dx Real-Time PCR Instrument ("ABI Fast Dx Instrument") under optimized conditions in a single tube generating amplicons for adenovirus and the Process Control (PRC). Identification of human adenovirus (HAdV) and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of adenovirus and the PRC.

The Lyra™ Adenovirus Assay is a real-time Polymerase Chain Reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus (HAdV) viral DNA from nasal and nasopharyngeal swab specimens. Its intended use is to aid in the diagnosis of HAdV in individuals showing symptoms of acute respiratory infections. The device detects HAdV species (A, B, C, D, E, and F) or serotypes (HAdV 1-52) but does not differentiate them.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical thresholds. However, it presents performance data that would implicitly serve as the criteria for substantial equivalence. Based on the provided clinical study results, the implied acceptance criteria would likely be high sensitivity and specificity against the reference methods.

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

Prospective Study (Test Set 1):

• Sample Size: 1241 fresh upper respiratory tract specimens initially, reduced to 1239 after excluding two invalid specimens.
• Data Provenance: Multi-center, prospective study. The document does not specify the exact countries of origin, but generally, FDA submissions imply US-based clinical studies unless otherwise stated. Specimens were collected and transported to labs daily and tested within 72 hours.

Retrospective Study (Test Set 2):

• Sample Size: 105 frozen upper respiratory tract specimens.
• Data Provenance: Retrospective study conducted at Site 1 (a pediatric hospital in the Southwest United States).

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Prospective Study:

• The ground truth (reference method) for the prospective study was a "composite method of direct fluorescent antibody staining (CDFA) followed by direct fluorescent antibody staining of the specimen (SDFA)."
• A specimen was considered positive if either CDFA or SDFA was positive.
• A specimen was considered negative if both CDFA and SDFA were negative.
• This method effectively acts as an adjudication by combining two established diagnostic methods. There isn't a stated number of human readers for each method, but CDFA and SDFA are laboratory techniques with their own interpretation protocols, likely performed by trained laboratory personnel.

Retrospective Study:

• The reference method for the retrospective study was an "additional FDA-cleared molecular device" (a comparator PCR assay). There is no mention of adjudication for this comparative analysis.

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:

This device is an in vitro diagnostic (PCR-based assay) and not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not performed and is not relevant to this submission.

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

The performance reported for the Lyra™ Adenovirus Assay (sensitivity, specificity, positive percent agreement, negative percent agreement) in both the prospective and retrospective studies represents the standalone performance of the device (algorithm/assay only) compared to the respective reference methods. This indicates the device's ability to detect HAdV without human interpretation affecting the outcome of the assay itself, although humans are involved in performing the test and interpreting the final qualitative result generated by the instrument.

7. The type of ground truth used:

• Prospective Study: A "composite method" of direct fluorescent antibody staining (CDFA) of viral culture and direct fluorescent antibody staining of the specimen (SDFA). This is a laboratory-based reference method, essentially a combination of viral culture and expert interpretation of fluorescent antibody staining.
• Retrospective Study: An "additional FDA-cleared molecular device" (a comparator FDA-cleared PCR assay).

8. The sample size for the training set:

The document does not explicitly describe a separate "training set" in the context of machine learning. For in vitro diagnostic assays like this, method development and optimization phases typically involve extensive internal testing and reagent optimization, which would be analogous to "training" certain parameters. However, the document provided focuses on the analytical and clinical validation studies.

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

As noted in point 8, a distinct "training set" with ground truth in the machine learning sense is not detailed. The development process of the Lyra™ Adenovirus Assay would have involved establishing its limits of detection (LoD) using quantified viral stocks (e.g., TCID50/mL), assessing inclusivity against known serotypes, and testing for cross-reactivity and interference against quantified organisms. These are established through recognized laboratory standards and methodologies rather than "ground truth" derived from expert consensus on patient cases in a training set.

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The Lyra Direct Strep Assay is a Real-Time PCR in vitro diagnostic test for the qualitative detection and differentiation of Group A ß-hemolytic Streptococcus (Streptococcus pvogenes) and pyogenic Group C and G B-hemolytic Streptococcus nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharvngitis, such as sore throat. The assay does not differentiate between pyogenic Groups C and G ß-hemolytic Streptococcus.

All negative test results should be confirmed by bacterial culture, because negative results do not preclude Group A, C or G Strep infection and should not be used as the sole basis for treatment.

The assay is intended for use in hospital, reference, or state laboratory settings. The device is not intended for point-of-care use.

The Lyra Direct Strep Assay detects nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. A multiplex Real-time PCR reaction is carried out under optimized conditions in a single tube generating amplicons for Group A B-hemolytic Streptococcus (Streptococcus pyogenes) and pyogenic Group C and G B-hemolytic Streptococcus, and the Process Control (PRC). Identification of Group A, pyogenic Group C/G, and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of Group A, pyogenic Group C/G, and the PRC. The assay does not differentiate between Group C and Group G streptococci.

A specimen from a patient's throat swab is transferred to the Process Buffer then heated to lyse the bacteria and expose the DNA. The lysed specimen is then added to a rehydrated Master Mix of targeted oligonucleotide primers, fluorophore and quencher-labeled probes is added to each plate. The plate is placed into the Applied Biosystems® 7500 Fast Dx instrument and the Quidel Molecular Direct Streptococci Assay protocol is initiated.

This assay is based on Taqman® chemistry, and uses an enzyme with DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the conserved complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in an increase in the fluorescent signal. If sufficient fluorescence is achieved, the sample is reported as positive for the detected nucleic acid.

{
  "acceptance_criteria_and_study": {
    "acceptance_criteria_table": {
      "headers": [
        "Performance Metric",
        "Acceptance Criteria (Implicit)",
        "Reported Device Performance"
      ],
      "data": [
        [
          "Precision/Repeatability (Group A Strep, High Negative)",
          "Acceptable detection rates",
          "45.8% Detection"
        ],
        [
          "Precision/Repeatability (Group A Strep, Low Positive)",
          "Acceptable detection rates",
          "100% Detection"
        ],
        [
          "Precision/Repeatability (Group A Strep, Moderate Positive)",
          "Acceptable detection rates",
          "100% Detection"
        ],
        [
          "Precision/Repeatability (Group A Strep, Negative)",
          "Acceptable detection rates",
          "0% Detection"
        ],
        [
          "Precision/Repeatability (Pyogenic Group C Strep, High Negative)",
          "Acceptable detection rates",
          "75% Detection"
        ],
        [
          "Precision/Repeatability (Pyogenic Group C Strep, Low Positive)",
          "Acceptable detection rates",
          "100% Detection"
        ],
        [
          "Precision/Repeatability (Pyogenic Group C Strep, Moderate Positive)",
          "Acceptable detection rates",
          "100% Detection"
        ],
        [
          "Precision/Repeatability (Pyogenic Group C Strep, Negative)",
          "Acceptable detection rates",
          "0% Detection"
        ],
        [
          "Reproducibility (Group A Strep, Low Pos, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "99% (89/89)"
        ],
        [
          "Reproducibility (Group A Strep, Mod Pos, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "100% (90/90)"
        ],
        [
          "Reproducibility (Group A Strep, Neg, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "0% (0/90)"
        ],
        [
          "Reproducibility (Pyo Group C Strep, Low Pos, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "100% (89/90)"
        ],
        [
          "Reproducibility (Pyo Group C Strep, Mod Pos, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "100% (90/90)"
        ],
        [
          "Reproducibility (Pyo Group C Strep, Neg, Combined)",
          "Acceptable detection rates (e.g., close to 100% for positive and 0% for negative)",
          "0% (0/90)"
        ],
        [
          "Analytical Specificity (Cross-reactivity)",
          "No cross-reactivity with common throat microorganisms",
          "None of the forty-four (44) microorganisms tested cross-react with the assay."
        ],
        [
          "Clinical Sensitivity (Group A Strep, All Sites)",
          "High sensitivity (no explicit numerical criteria, but implied to be high for regulatory acceptance)",
          "96.5% (95% CI: 91.3%-98.6%)"
        ],
        [
          "Clinical Specificity (Group A Strep, All Sites)",
          "High specificity (no explicit numerical criteria, but implied to be high for regulatory acceptance)",
          "98.0% (95% CI: 97.0%-98.6%)"
        ],
        [
          "Clinical Sensitivity (Pyogenic Group C and G Strep, All Sites)",
          "High sensitivity (no explicit numerical criteria, but implied to be high for regulatory acceptance)",
          "95.7% (95% CI: 88.1%-98.5%)"
        ],
        [
          "Clinical Specificity (Pyogenic Group C and G Strep, All Sites)",
          "High specificity (no explicit numerical criteria, but implied to be high for regulatory acceptance)",
          "98.3% (95% CI: 97.4%-98.9%)"
        ]
      ]
    },
    "test_set_sample_size": "1293 prospectively collected fresh throat specimens.",
    "test_set_data_provenance": "United States, prospective.",
    "number_of_experts_ground_truth": "The document does not explicitly state the number of experts used to establish ground truth for the clinical study. However, the ground truth was established by microbiological culture, which typically involves trained laboratory personnel but not necessarily an 'expert consensus' in the sense of multiple independent clinical expert opinions on each case.",
    "qualifications_of_experts": "Not explicitly stated for the clinical ground truth. For culture methods, typically microbiologists or trained laboratory technologists perform and interpret the results.",
    "adjudication_method": "Not applicable in the context of expert consensus. The ground truth was based on a composite culture method: a specimen was considered positive if culture from either the directly plated swab or the transport fluid material was positive for the target streptococci. This is a laboratory-based reference standard, not an adjudication of expert opinions.",
    "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compares the device performance to a reference standard (culture), not to human readers with and without AI assistance.",
    "standalone_performance_study": "Yes, the clinical sensitivity and specificity results 'vs. Composite Cultures' (Tables X and XI) represent the standalone performance of the algorithm/device without human-in-the-loop assistance for interpretation of primary results.",
    "type_of_ground_truth": "Expert reference standard based on **composite bacterial culture** (directly plated throat swabs and culture of transport fluid material). Cultured isolates were typed by latex agglutination, and beta-hemolytic isolates were speciated using MALDI TOF.",
    "training_set_sample_size": "The document does not explicitly state the sample size for a 'training set'. The data presented are for analytical and clinical validation. While the device developers would have utilized data during development, specific training set sizes are not provided in this regulatory submission for a diagnostic device.",
    "ground_truth_for_training_set": "Not explicitly stated. For PCR-based assays, 'training' typically involves optimizing assay parameters (primers, probes, cut-offs) using characterized bacterial strains and spiked samples (e.g., as described in the Analytical Sensitivity and LoD sections), rather than a large clinical training set with expert ground truth in the same way an AI model might be trained."
  }
}

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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Lyra Acupuncture Needles." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, good manufacturing practice).
• Stating the intended "Indications For Use" for the device, which is "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The Lyra™ Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

The Lyra™Nasal Mask is intended for the delivery of air from either a CPAP or bi-level instrument (delivery device). The breathing circuit consists of the Lyra, which directly interfaces with the patient, and a pair of tubes, which connect the Lyra to the delivery device. The delivery device provides positive pressure air to the patient via the tubes and the Lyra™. Exhalation ports on the Lyra™ allows patient-exhaled gases to exhaust to the atmosphere.

The Lyra™ consists of the following:

• two nasal prongs, which are easily removed or installed into a mask body for the interchange of different sizes, and for easy cleaning of the device;
• adjustable head gear, which keeps the nasal mask in place during use;
• a pair of tubings, with one end of the tubings attached to the mask body;
• a standard 22-mm swivel which attached to the other end of the tubings.

The delivery device interfaces with the swivel via corrugated tubing, with a standard 22mm fitting.

The Lyra™ nasal prongs, made from a soft, flexible silicone, form a seal with the patient's nares. The nasal prongs come in different sizes for better and more comfortable fit for patients with varying nares sizes.

The Lyra™ is packaged, along with instructions for use and recommended cleaning instructions, in a poly bag. The Lyra™ can be completely disassembled for cleaning. Mild soap and water may be used to clean the device.

The provided text describes a medical device, the Lyra™ Nasal Mask, and its 510(k) submission for market clearance. While it discusses the device's description, intended use, and a comparison to a predicate device, it does not contain detailed information about a clinical study with specific acceptance criteria and performance metrics in the way that would typically be presented for an AI/ML device.

This submission is for a physical medical device (a nasal mask), and the "performance testing" described is much simpler and focuses on physical characteristics compared to a software-based diagnostic or prognostic device.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Based on "LACK OF" detailed clinical study)

Missing Information (Not provided in the document for the Lyra™ Nasal Mask):

Many of your requested points relate heavily to the evaluation of AI/ML-based medical devices or more extensive clinical trials, which are not detailed in this 510(k) summary for a physical medical accessory.

1. Sample size used for the test set and the data provenance: Not applicable in the context of this device's "bench testing." The "test set" here refers to the actual physical devices tested, not patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device parameters (like leak rates) in bench testing does not involve medical experts in the same way an AI diagnostic would.
3. Adjudication method: Not applicable for bench testing of a physical device.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned. Such studies are typically for diagnostic AI systems.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
6. The type of ground truth used: For physical parameters like leak rates and dead space, the "ground truth" would be objective measurements obtained through standardized bench testing methods, not expert consensus, pathology, or outcomes data.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable for the same reason.

In summary: The provided text details a 510(k) submission for a physical nasal mask. The "study" proving it meets "acceptance criteria" is a comparative bench testing against a predicate device, focusing on physical parameters like leak rates, dead space, environmental performance, and cleaning. The primary "acceptance criterion" for 510(k) clearance in this context is demonstrating substantial equivalence to a legally marketed predicate device. The document explicitly states: "There are no known mandatory or voluntary performance standards applicable to this device classification."

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The Laserscope Lyra TM Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.

The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.

The provided text describes the Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria from an AI/algorithm perspective.

This document is a traditional medical device 510(k) summary for a physical laser system, not for a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "ground truth," "MRMC study for AI improvement," and "standalone algorithm performance" are not applicable in the context of this specific regulatory submission.

Here's what can be extracted and what cannot:

Information from the provided text:

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

• Acceptance Criteria: The document only broadly states that "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles." Specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific patient satisfaction score) are not provided.
• Reported Device Performance: Similarly, specific performance metrics are not provided. The document only offers a general statement about safety and effectiveness.

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

• Test Set Sample Size: Not provided.
• Data Provenance: The document mentions "Clinical studies," implying prospective data collection on human subjects, but does not specify country of origin or whether it was retrospective.

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

• This concept of "experts establishing ground truth" is typically associated with AI model validation where human experts label data. For a physical laser device for wrinkle treatment, the "ground truth" would likely be direct clinical observation by physicians, patient self-assessment, or possibly photographic analysis by a panel of evaluators. However, none of this detail is provided.

4. Adjudication method for the test set:

• Not provided.

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 a physical laser device, not an AI system being evaluated to assist human readers.

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

• Not applicable. This is a physical laser device.

7. The type of ground truth used:

• The document implies the ground truth was based on clinical outcomes relevant to "safety and effectiveness for the treatment of facial wrinkles." This would likely involve physician assessment, possibly patient questionnaires, and potentially photographic evidence, but specifics are not given. It is not pathology or genetic data.

8. The sample size for the training set:

• Not applicable / not provided. The concept of a "training set" applies to machine learning models, not typically to the direct development and testing of a physical medical device. While there were clinical studies, they are not referred to as a "training set" in this context.

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

• Not applicable / not provided.

In summary of what is available from the document:

• Device Type: Laserscope Lyra™ Surgical Laser System & Accessories (Nd:YAG laser)
• Intended Use: Dermatological applications for the treatment of facial wrinkles.
• Performance Claim: "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles."
• Nonclinical Data: None mentioned for this specific submission, likely relying on prior predicate device data for engineering performance.
• Clinical Data: Yes, clinical studies were performed to support safety and effectiveness. However, no details about the study design, sample size, specific endpoints, or results are included in this 510(k) summary.

This 510(k) summary serves to establish substantial equivalence to predicate devices, and as such, often omits the granular detail of clinical study results that would typically be found in a full clinical study report or a PMA submission requiring more extensive evidence.

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