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The Molecular Transport Media - MTM is intended for the stabilization, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.

The MTM consists of a pre-filled plastic tube containing either 2 or 3 mL of proprietary liquid medium intended for viral nucleic acid stabilization and transportation and inactivation of nasopharyngeal swab specimens suspected of containing SARS-CoV-2. MTM is intended for use with standard diagnostic/identification techniques that have been adequately validated and found to be compatible with the MTM. The formulation of the MTM includes guanidine-free inactivation buffer, salts, a buffer to maintain a neutral pH, and distilled water.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

The document is a 510(k) Summary for the Molecular Transport Media - MTM. It describes non-clinical performance and shelf-life studies. No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Molecular Transport Media - MTM:

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

• Shelf-Life Study (Physical & pH Stability):
  • Test Set Sample Size: Three lots, with three replicates per lot, tested at 7 time points (T=0, 3, 6, 9, 12, 15, 18 months).
  • Data Provenance: Not explicitly stated, but implies laboratory testing internal to the manufacturer or a contract lab. Prospective for the duration of the 18-month test.
• Limit of Detection (LoD) Study:
  • Preliminary LoD Test Set Sample Size: Not clearly defined as a fixed "test set." It involved serial dilutions, with triplicate testing for each concentration for three lots.
  • Confirmatory LoD Test Set Sample Size: 20 replicates for each of three SARS-CoV-2 concentrations (1.35E+04, 1.35E+03, and 1.35E+02 PFU) across different MTM lots and temperatures.
  • Data Provenance: Not explicitly stated, but implies laboratory testing. The "pooled negative clinical nasal samples" suggest human specimens were used as matrix, but the virus stock was laboratory-prepared. Retrospective for the negative clinical samples, prospective for the spiked virus testing.
• Viral Nucleic Acid Stability Study:
  • Test Set Sample Size: Not clearly defined as a fixed "test set." Triplicate rayon swabs per lot and per temperature condition (15°C and 35°C) at 4 time points (0, 7, 14, 21 days).
  • Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled negative clinical nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.
• Viral Inactivation Study:
  • Cytotoxicity Test Set Sample Size: Triplicate for each 10-fold serial dilution (1:10E+01 to 1:10E+08) for each of the three lots, at both 15°C and 35°C.
  • Viral Inactivation Test Set Sample Size: Triplicate for each MTM lot number at 15°C and 35°C at three time points (0, 5, and 15 minutes post inoculation). Serially diluted (10-fold) to 1:10E+01 to 1:10E+08 in triplicate for plaque assay.
  • Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled clinical negative nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.

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

The document describes non-clinical laboratory studies. No human experts were used to establish ground truth in the context of clinical interpretation. The ground truth in these studies is based on quantifiable laboratory measurements (e.g., PFU counts, Ct values, pH, visual appearance) against pre-defined scientific criteria. For example, confirmation of presence/absence of virus based on TaqPath COVID-19 Combo Kit interpretation (Table 3), or visual assessment of CPE for cytotoxicity.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, quantifiable laboratory study, not a study involving human interpretation or adjudication of results. The results are based on direct measurements and adherence to pre-defined thresholds.

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

No MRMC comparative effectiveness study was done. This is a device for molecular transport media, not an AI-assisted diagnostic tool.

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

Standalone performance was not done in the context of an AI algorithm. The device itself functions in a standalone manner as a transport medium; its performance attributes (nucleic acid stabilization, preservation, viral inactivation) are assessed directly.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Quantitative Laboratory Measurements:
  • Limit of Detection: Defined by the ability to repeatedly detect SARS-CoV-2 RNA above a 95% accuracy threshold using a legally marketed molecular diagnostic kit (TaqPath COVID-19 Combo Kit) and measured Ct values.
  • Viral Nucleic Acid Stability: Defined by positive detection of SARS-CoV-2 RNA and Ct variation (ΔCt) within ±3 Ct values, measured using the TaqPath COVID-19 Combo Kit.
  • Viral Inactivation: Defined by the absence of plaque-forming units (PFUs) on Vero cells after exposure to the MTM, and by the absence of Cytopathic Effect (CPE) for cytotoxicity.
  • Shelf-Life: Defined by objective physical characteristics (color, turbidity, precipitate) and measurable pH values within a specified range.

8. The Sample Size for the Training Set

No training set was used. This device is a molecular transport medium, not a machine learning or AI algorithm.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

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The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.

The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.

The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.

The provided text describes the 510(k) premarket notification for the ALB Luz Viral Transport Media (VTM). This document details the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the kind of information typically associated with acceptance criteria and clinical study results for an AI-powered medical device, such as:

• Accuracy metrics: Sensitivity, specificity, AUC, F1 score.
• Study design details: Retrospective/prospective, number of patients/cases in the test set.
• Expert ground truth: Number of experts, their qualifications, adjudication methods.
• Comparative effectiveness: MRMC study details, human reader improvement with AI.
• Standalone algorithm performance.
• Training set details: Size, ground truth establishment.

Instead, the document focuses on performance testing relevant to a viral transport medium, specifically:

• Shelf-life studies: Physical stability (appearance, volume) and pH stability over 18 months.
• Sterilization checks: Absence of microbial growth.
• Viral recovery studies: Using plaque forming assays to show the device maintains viral viability for specific viruses (Influenza A, RSV, Rhinovirus) at different temperatures and time points (0, 24, 48 hours).

Therefore, I will interpret the request in the context of the provided document, defining "acceptance criteria" and "device performance" based on the characteristics and tests described for the Viral Transport Media, rather than an AI-powered device.

Acceptance Criteria and Study Proving Device Meets Criteria

The ALB Luz Viral Transport Media (VTM) is a Class I, reserved medical device (Product Code JSM) intended for the collection and transport of upper respiratory clinical specimens containing specific viruses. The study presented in the 510(k) summary (K232454) demonstrates the device's ability to maintain the viability of these viruses over time and under specified storage conditions, thereby proving its suitability for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Viral Transport Media are based on its ability to maintain physical and chemical stability, minimize contamination, and crucially, maintain the viability of specific viruses over a defined transport/storage period. The performance is assessed against these criteria.

• 2-8°C: Percent changes for 24 hours range from 0% to -9%; for 48 hours, -35% to -38%.
• 20-25°C: Percent changes for 24 hours range from -7% to -20%; for 48 hours, -33% to -39%.
  Respiratory Syncytial Virus (RSV):
• 2-8°C: Percent changes for 24 hours range from -11% to 7%; for 48 hours, -38% to -50%.
• 20-25°C: Percent changes for 24 hours range from -15% to 0%; for 48 hours, -36% to -43%.
  Rhinovirus:
• 2-8°C: Percent changes for 24 hours range from 0% to 5%; for 48 hours, -33% to -52%.
• 20-25°C: Percent changes for 24 hours range from -21% to -18%; for 48 hours, -29% to -46%.
  All reported percent changes are well within the ±90% acceptance criterion. |

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

• Sample Size (Test Set): For the viral recovery studies, "Three lots of VTM with newly manufactured, mid-range lot and close to expiry lots were used." For each lot, virus stock was serially diluted, transferred into VTM, and stored at two temperatures (2-8°C and 20-25°C) for three time points (0, 24, 48 hours). For each condition, viral samples were serially diluted and "added to the monolayer in triplicate."
  • This implies a sample size of 3 lots x 2 temperatures x 3 time points x 3 replicates = 54 measurements per virus strain. Since three virus strains were tested, the total number of primary viral recovery measurements would be 162 (excluding the initial virus stock titrations and cell culture maintenance).
• Data Provenance: The study appears to be an in-vitro laboratory validation study rather than a clinical trial with patient data. The specific origin of the "pooled negative clinical nasal matrix" is not explicitly stated in terms of country, but the sponsor is based in Brazil.
• Retrospective or Prospective: The study design described (testing newly manufactured, mid-range, and close-to-expiry lots, and specific time points) indicates a prospective laboratory validation study for performance characteristics, particularly viral recovery and shelf-life.

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

This section is not applicable in the context of this device and study. The "ground truth" for Viral Transport Media performance is established through direct laboratory measurements of viral viability (Plaque-Forming Units/mL) and physical/chemical properties (pH, appearance). No human expert interpretation of images or clinical data for diagnosis is involved.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. There is no human interpretation or diagnostic decision-making that would require adjudication.

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

No. An MRMC study is relevant for AI (or other diagnostic) devices where human readers interpret medical images or data. This is a laboratory performance validation for a transport medium.

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

No. This section pertains to AI algorithms. The device under review is a physical transport medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation of the Viral Transport Media is based on direct laboratory measurements of viral viability (Plaque-Forming Units/mL) through plaque assays and physical/chemical measurements (pH, visual inspection for appearance/volume). This is an objective, quantitative, and directly observable ground truth.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning device that requires a "training set." The performance evaluation is based on laboratory testing of the manufactured product.

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

This section is not applicable for the same reason as above.

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