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Light Diagnostics™ Human Metapneumovirus DFA Kit is intended for the detection and identification of human metapneumovirus (hMPV) in direct respiratory specimen cell preparations from nasopharyngeal swabs from patients with febrile respiratory illness. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.

Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by FDA cleared hMPV molecular assay.

For In Vitro Diagnostic Use.

Light Diagnostics Human Metapneumovirus DFA Kit utilizes a single reagent for the detection and identification of human metapneumovirus. The fluorescein labeled monoclonal antibodies, specific for human metapneumovirus will bind to viral antigen in human metapneumovirus infected cells. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS/Tween 20). Illumination allows visualization of the antigenantibody complex by fluorescence microscopy. When a FITC filter set is used, the human metapneumovirus antibody complex will exhibit an apple-green fluorescence. Uninfected cells stain a dull red due to the presence of Evans blue in the reagent.

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

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

• Sample Size for Test Set: 411 nasopharyngeal swab specimens.
• Data Provenance: Retrospective clinical specimens were collected from two sites:
  • Site One: A regional medical center in southeastern Canada (208 specimens).
  • Site Two: A hospital laboratory in the northeastern United States (199 specimens).
  • Site Three: Additional 200 specimens were submitted for testing, of which four were nasopharyngeal swabs.

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 test set.

4. Adjudication method for the test set

The ground truth for the test set was established using a composite algorithm based on cell culture results and a validated RT-PCR method followed by bidirectional sequencing for confirmation and identification of human metapneumovirus. This implies a hierarchical or multi-modal adjudication process rather than an expert-based one.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a direct immunofluorescence assay (DFA) device against a composite reference method, not human reader performance with or without AI assistance.

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

This study evaluates a diagnostic kit which is inherently intended for use by a human operator (reading fluorescence microscopy slides). Therefore, a purely standalone "algorithm only" performance (without human-in-the-loop) was not conducted in the context of an automated AI system. The performance presented for the Light Diagnostics™ hMPV DFA Kit represents its performance when used as intended by an operator.

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

The type of ground truth used was a composite algorithm based on cell culture results and a validated RT-PCR method followed by bidirectional sequencing for confirmation and identification of human metapneumovirus.

8. The sample size for the training set

The document does not explicitly mention a separate "training set" sample size for an AI algorithm. This submission describes the validation of a diagnostic kit (DFA) which relies on antibody-antigen binding observed via microscopy by a human, not a machine-learning based algorithm that would typically require a training set. If the "training set" refers to the data used to develop the assay's reagents, it is not specified.

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

As there is no explicit mention of a training set for an AI algorithm, the method for establishing its ground truth is not applicable/not provided in this document. The assay's development (e.g., selection of monoclonal antibodies) would have been guided by traditional laboratory methods for identifying hMPV, but this is not akin to a machine learning training set ground truth establishment.

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The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.

For In Vitro Diagnostic Use.

Light Diagnostics™ HSV 1/2 Typing DFA Kit is a qualitative test that uses specific typing reagents and FITC filter fluorescence microscope to detect and differentiate herpes simplex viruses 1 and 2 in direct specimens from symptomatic patients with lesions and in specimens amplified by cell culture. The kit consists of HSV-1 Typing Reagent vial, HSV-2 Typing Reagent vial, two HSV Control Slides, Phosphate-Buffered Saline packet; Tween 20/Sodium Azide Solution (100X) vial, and Mounting Fluid vial. The kit utilizes specific reagents for the detection and identification of HSV-1 and HSV-2, therefore two cell spots on slides of specimens are required to identify the type of HSV. The HSV-1 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies specific for HSV-1 glycoprotein C and ICP35 respectively. The HSV-2 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies that specifically bind HSV-2 polypeptides. In Western blots these appear as two major bands with molecular weights of between 110-120 kD and between 78-82 kD and are consistent with the monoclonal antibodies recognizing epitopes within glycoprotein G of HSV-2. The typing reagents will bind to HSV-1 or HSV-2 infected cells fixed on microscope slides specifically. Separate cell spots on slides should be prepared for use with each reagent. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. HSV-infected cells will exhibit apple-green fluorescence with the specific reagent while cells stain a dull red due to the presence of Evans blue in the typing reagents. The controls contained in this kit are acetone fixed slides with one well containing HSV-1 infected cells, one well containing HSV-2 infected cells, and one well containing uninfected cells to verify functioning of reagents, culture methodology and functioning of the microscope.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= X%"). Instead, it presents the performance characteristics found and concludes that they demonstrate substantial equivalence to the predicate device. The comparison studies were performed against "Culture Confirmation with HSV typing reagent," which served as the reference standard.

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

• Sample Size for Direct Specimen Testing:
  • Total collected: 454 specimens
  • Excluded for HSV-1 direct analysis due to insufficient cells: 16 specimens
  • Excluded for HSV-2 direct analysis due to insufficient cells: 18 specimens
  • Culture results not recorded for: 3 specimens
  • Effective Sample Size (HSV-1 Direct): 438 specimens (454 - 16)
  • Effective Sample Size (HSV-2 Direct): 436 specimens (454 - 18)
• Sample Size for Culture Testing (Amplified Specimens):
  • Total: 176 specimens (from the initial 454 specimens that grew on culture)
• Data Provenance: Clinical specimens were collected from three sites in the United States: 258 samples from the Eastern region and 196 from the Southeastern region. The study explicitly states it was a "Clinical Evaluation" using "specimens collected from three sites from symptomatic patients with lesions," indicating a prospective collection of real-world patient samples.

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

The document does not specify the number or qualifications of experts involved in establishing the ground truth. It states that "Culture Confirmation with HSV typing reagent" was used as the reference standard. For direct specimen analysis, fluorescence microscopy was used to examine slides stained with the Light Diagnostics™ kit and a reference HSV typing reagent. For cell culture, observers would typically assess cytopathic effect (CPE) for the presence of HSV. The interpretation of these methods would usually be performed by trained laboratory personnel or clinical microbiologists, but no specific details on their number or qualifications are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The reference standard for comparison was "Culture Confirmation with HSV typing reagent." It implies a direct comparison of the investigational device's results against this established reference, rather than a multi-reader adjudication process for the ground truth itself.

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 explicitly described. The study focuses on evaluating the performance of the device against a predicate or reference method (cell culture with HSV typing reagent) rather than assessing human reader improvement with or without AI assistance. The device itself is an immunofluorescence assay kit, not an AI-based system.

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

Yes, in a sense, a standalone performance was done. The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test kit. Its "performance" is measured by its ability to detect and differentiate HSV-1 and HSV-2 antigens in patient samples via immunofluorescence without human "interpretation assistance" beyond standard laboratory procedures (e.g., slide reading under a microscope). The results presented (sensitivity and specificity) represent the performance of the kit itself when compared to the reference standard. There is no AI algorithm involved.

7. The Type of Ground Truth Used

The primary ground truth used was molecular/biological confirmation via cell culture (with HSV typing reagent). For direct specimen testing, the device's results were compared to "culture isolation." For culture testing (amplified specimens), the device's performance was compared against a "Predicate HSV typing reagent" used on culture-amplified specimens. This implies that the presence or absence and typing of HSV were determined by cell culture methods and confirmed with a reference HSV typing reagent.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This is a traditional in vitro diagnostic device, and thus, the concept of a training set for an algorithm is not applicable. The non-clinical evaluations involving reference strains and clinical isolates (e.g., 8 HSV-1 isolates, 7 HSV-2 isolates, other viruses, bacteria, and cell lines) served as an internal validation and specificity check (see "Non-clinical evaluation" section), rather than a training set for an algorithm.

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

As there is no "training set" in the AI sense, this question is not applicable. For the non-clinical evaluation, the ground truth was established by using known reference strains (e.g., ATCC VR733/735 for HSV-1, ATCC VR734 for HSV-2) and "previously typed clinical isolates," indicating these were characterized and verified prior to being used in the specificity assessment.

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Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Millex®- HV, VV, GV Syringe Filter Unit." It is an approval for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is a premarket notification process that demonstrates a new device is as safe and effective as a legally marketed device (predicate device). It primarily focuses on comparing the new device to an existing one. It does not typically include detailed performance study results, acceptance criteria, or ground truth establishment in the way that would be seen for a new, novel device requiring a PMA (Premarket Approval) or for AI/ML-driven devices.

Therefore, I cannot provide the requested information from this document. The document confirms that the device is intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications, and that it has been deemed substantially equivalent to a predicate device.

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Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Millex- GP Sterilizing Filter Unit

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria for device performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text.

The document primarily focuses on:

• Device Name: Millex- GP Sterilizing Filter Unit
• Regulation Number/Name: 868.5130, Anesthesia Conduction Filter
• Regulatory Class: II
• Product Code: BSN
• Indications for Use: Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
• FDA's finding: Substantially equivalent to legally marketed predicate devices.

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For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Millex - MP Sterilizing Filter Unit

I am sorry, but based on the provided document excerpts, there is no information available regarding acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the "Millex® - MP Filter Unit," which primarily addresses the substantial equivalence of the device to a predicate device for its intended use.

The letter and the enclosed "Indications for Use Statement" do not contain details about:

• Specific performance metrics or acceptance criteria for the filter.
• Any performance study results (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
• Details about training sets or their ground truth establishment.

The document states the device's indications for use: "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." The FDA's clearance is based on its determination of substantial equivalence, which implies that the device performs as intended and is as safe and effective as a legally marketed predicate device, but the specific data proving this from a primary study are not included in these excerpts.

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