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Remel Spectra™ ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra™ ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment.

Do not report Spectra™ ESBL positive screening results. Subculture of presumptive positive colonies to non-selective medium (e.g. Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing.

A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra™ ESBL does not preclude the presence of ESBL producing organisms.

Spectra™ ESBL contains a combination of antibacterial agents which aid in inhibiting non-ESBL Enterobacteriaceae and suppress the growth of some AmpC organisms and other non-ESBL flora. Peptones supply amino acids and essential nutrients which promote the growth of enteric gram-negative bacilli. Sodium chloride is a source of essential electrolytes and maintains osmotic equilibrium. Phosphate buffers are added to maintain the pH.

A mixture of chromogens forms a substrate for two enzymes: βgalactosidase and glucuronidase that are differentially expressed in different species of bacteria resulting in blue/turquoise-green or pink colonies. Other ESBL-producing organisms that do not utilize the chromogenic substrates may produce tan colonies through deamination of tryptophan. Non-target organisms generally appear cream colored or are naturally pigmented green or brown.

The provided text describes the performance evaluation of the Remel Spectra™ ESBL device. The following information details the acceptance criteria and study findings:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document implicitly defines "high agreement" as the acceptance criterion for sensitivity, specificity, PPA, and NPA, demonstrated by the reported percentages and confidence intervals. Reproducibility, reactivity, and cross-reactivity have explicit criteria.

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

• Sample Size: A total of 1176 prospective rectal swab (439) and fecal (737) surveillance specimens.
• Data Provenance: Clinical data collected prospectively from three different clinical hospitals in the United States.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that the ground truth was "obtained from growth on MacConkey agar with a 10μg cefpodoxime disk […], followed by biochemical identification and disk diffusion phenotypic confirmatory antimicrobial susceptibility testing for ESBLs as outlined in the Clinical and Laboratory Standards Institute document M100-S23." This implies adherence to a standardized protocol rather than individual expert consensus for each case.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method involving multiple human readers for the test set. The reference method (ground truth) appears to be based on a standardized laboratory protocol.

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 mentioned or performed. The study evaluates the performance of the Remel Spectra™ ESBL device against a laboratory-based reference method, not against human readers with or without AI assistance.

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

This study directly assesses the standalone performance of the Remel Spectra™ ESBL agar medium as a diagnostic tool. The interpretation of results ("Manual, visual") is performed by laboratory personnel, but the "device" itself (the culture medium) provides the observable outcome (colony color and growth) which is then interpreted. So, in essence, it's a standalone diagnostic performance assessment of the medium.

7. The Type of Ground Truth Used:

The ground truth was established by a laboratory-based reference method, which included:

• Growth on MacConkey agar with a 10µg cefpodoxime disk.
• Selection of colonies from within the zone of inhibition.
• Biochemical identification.
• Disk diffusion phenotypic confirmatory antimicrobial susceptibility testing for ESBLs as outlined in the Clinical and Laboratory Standards Institute document M100-S23.

8. The Sample Size for the Training Set:

The document does not mention a specific "training set" in the context of machine learning or AI models. This device is a culture medium, and its development (which would be analogous to a training phase) involves formulation and empirical testing, rather than a data-driven training set in the AI sense. The "Reactivity" and "Reproducibility" studies involve a limited number of isolates (48 confirmed ESBL-producing strains for reactivity; 9 blinded ESBL and Non-ESBL isolates for reproducibility) that could be considered part of the development/validation process.

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 directly applicable. For the isolates used in "Reactivity" and "Reproducibility" studies, their ESBL status was "confirmed" (for reactivity) and "expected" (for reproducibility), implying that a definitive laboratory method was used to classify them prior to testing with the Spectra™ ESBL. This would likely follow similar gold standard methods as the clinical study's ground truth.

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Remel Xpect® Flu A&B is a in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.

The Xpect® Flu A&B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample wells of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibody-antigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

Here's an analysis of the provided text regarding the Remel Xpect® Flu A&B device, structured according to your request:

Acceptance Criteria and Study Details for Remel Xpect® Flu A&B

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on analytical sensitivity as the performance metric for this submission. While a single, overarching acceptance criterion isn't explicitly stated as a pass/fail threshold, the study's purpose is to demonstrate the device's ability to detect various influenza strains, including the newly added A/Anhui/1/2013 (H7N9). The "Detection Limit" column in the table below represents the reported device performance for each strain.

Note: The document explicitly states: "Although this test has been shown to detect the influenza A/California/04/2009 (H1N1) and A/Anhui/1/3012 (H7N9) viruses cultured from positive human specimens, the performance characteristics of this device with human specimens infected with these influenza A viruses have not been established." This indicates that the analytical sensitivity data presented here is for cultured viral strains, not directly from human clinical samples for the A/H1N1 and A/H7N9 strains mentioned.

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

• Sample Size: The test set for analytical sensitivity consisted of 17 influenza strains (11 influenza A and 6 influenza B).
• Data Provenance: The data comes from laboratory testing of cultured viral strains. The country of origin for the data is not specified, but it is implied to be internal laboratory work conducted by Remel Inc. The study is a prospective experimental study in a controlled laboratory setting, not a retrospective analysis of clinical data.

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

Experts are not mentioned in the context of establishing ground truth for the analytical sensitivity test set. The ground truth for this type of test is typically based on the quantitated viral stock concentrations and the known presence/absence of the specific influenza strains.

4. Adjudication Method for the Test Set

Adjudication methods are not applicable and not mentioned for this analytical sensitivity study. The determination of a "positive endpoint" for each viral strain would be based on consistent visual readability of the test line by laboratory personnel following a defined protocol, not by expert consensus or adjudication of ambiguous 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 based on the provided text. The submission focuses on analytical sensitivity, not reader performance or human-AI interaction.

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

Yes, a standalone study was done. The analytical sensitivity study evaluates the device's ability to detect different influenza strains at specified concentrations without human interpretation variability being a primary variable. The Remel Xpect® Flu A&B is a visual read immunochromatographic test, meaning the "algorithm" is the biochemical reaction itself, and the "standalone" performance refers to its ability to react correctly to various concentrations of target analytes. While human visual interpretation is involved, the study assesses the inherent detection capability of the test.

7. The Type of Ground Truth Used

The ground truth used for the analytical sensitivity study is the known concentration (quantitation and titration) of well-characterized influenza viral strains. This is measured as TCID50/ml (50% tissue culture infectious dose) or CEID50/ml (50% chicken embryo infectious dose).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device or study description. The Remel Xpect® Flu A&B is a chemical-biological immunoassay, not a machine learning or AI-driven diagnostic device that requires a training set.

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

As stated above, a training set is not applicable to this device. Therefore, no ground truth for a training set was established.

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Remel RPMI 1640 Agar w/ MOPS and 2% Glucose is a solid medium recommended for use with antibiotic gradient-based systems for quantitative determination of susceptibility to antifungal agents when testing Candida spp. directly from colonies grown on nonselective media.

RPMI-1640 was developed by Moore et al. at Roswell Park Memorial Institute. The formulation is based on the RPMI- 1630 series of media utilizing a bicarbonate buffering system and alterations in the amounts of amino acids and vitamins. RPMI-1640 medium has demonstrated wide applicability in cell culture and also as the reference method for antifungal broth microdilution recommended by Clinical Laboratory Standards Institute (CLSI). When properly supplemented with MOPS, glucose, and agar RPMI-1640 has demonstrated accuracy for use with gradient-based systems with results comparable to that obtained with the CLSI reference method for testing Candida spp. against antifungal agents. The gradient method is based on a combination of the concepts of both dilution and diffusion tests, but differs from conventional disk methods by the use of a preformed, stable antibiotic gradient strip. When the strip is applied to the inoculated agar plate, there is an immediate release of the antibiotic into the agar matrix. A continuous and exponential gradient of antibiotic concentration is created beneath the carrier. After incubation a symmetrical inhibition ellipse centered along the carrier is seen. The zone edge intersects the strip at the minimum inhibitory concentration (MIC) value given in ug/ml. For antifungal testing, due to trailing effect, MICs should be read at approximately 90% inhibition of growth, ignoring faint hazes and minute colonies for flucytosine and 80% inhibition for fluconazole and itraconazole.

The provided document describes a 510(k) premarket notification for a culture medium (Remel RPMI 1640 Agar w/ MOPS and 2% Glucose) used for antifungal susceptibility testing. It is a submission for a new in-vitro diagnostic device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or cannot be extracted from this type of document, as it pertains to AI/ML device evaluation.

However, I can extract information related to the device's intended use and comparison to a predicate device, which implicitly defines its acceptance criteria in the context of a 510(k) submission (i.e., substantial equivalence to the predicate).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (culture medium), "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device performs similarly in its intended application. The document focuses on comparing the characteristics of the new device to its predicate.

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

The document does not specify a "test set" sample size in the context of AI/ML evaluation. It mentions "results comparable to that obtained with the CLSI reference method," implying that studies were conducted to compare the device's performance against a recognized standard using relevant microbial strains and antifungal agents. However, specific numbers of isolates, data origin (country), or whether the data was retrospective or prospective are not detailed in this summary.

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

This information is not applicable and not provided. The "ground truth" for this type of device would typically be established by established microbiological methods (e.g., CLSI reference method) and not by expert human graders of images or features.

4. Adjudication method for the test set

This information is not applicable and 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

This is not an AI/ML powered device, so an MRMC study related to AI assistance is not applicable.

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

This is not an AI/ML powered device, so standalone algorithm performance is not applicable.

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

The "ground truth" for evaluating the performance of this culture medium would be the Minimum Inhibitory Concentration (MIC) values determined by a Clinical and Laboratory Standards Institute (CLSI) reference method. The submission explicitly states the device's results are "comparable to that obtained with the CLSI reference method."

8. The sample size for the training set

This is not an AI/ML powered device, so a "training set" in that context is not applicable.

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

This is not an AI/ML powered device, so "ground truth for the training set" is not applicable.

Summary of the Study Proving Acceptance Criteria:

The document indicates that the device's performance was evaluated by comparing its results to those obtained with the CLSI reference method for antifungal susceptibility testing of Candida spp. against antifungal agents. This comparison demonstrated "accuracy for use with gradient-based systems with results comparable" to the CLSI reference method. While specific study details (like sample size numbers, statistical methods, or full data tables) are not provided in this 510(k) summary, the statement about comparability to the CLSI reference method is the core evidence presented to establish substantial equivalence and thus, acceptance. The "acceptance criteria" were met by demonstrating that the new culture medium provides reliable and comparable MIC results when used with antibiotic gradient-based systems for Candida spp. as per established microbiological standards.

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REMEL's Par-One™ is a medium recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system.

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This document is a marketing clearance letter from the FDA for the Remel Inc. Par-One™ device, which is a medium for the transportation, preservation, and examination of stool specimens for intestinal parasites. As a 510(k) clearance letter, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with acceptance criteria and comprehensive performance data in the format requested.

Therefore, many of the specific details regarding acceptance criteria, study design, expert qualifications, sample sizes, and ground truth establishment are not present in this type of regulatory document. The FDA clearance is based on the submission demonstrating the device is as safe and effective as a legally marketed predicate device.

However, I can extract what information is available or infer from the context:

Here's an attempt to answer your questions based on the provided document, with an acknowledgment of what information is missing:

1. Table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or specific reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device. This implies that the device's performance was deemed to be at least as good as the predicate's for its intended use, but the specific numerical performance data and acceptance criteria from the company's internal studies are not detailed here.

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

• Sample Size for Test Set: Not specified in this document.
• Data Provenance: Not specified in this document. Typically, for a device like this, studies would involve human stool samples. Whether they were retrospective or prospective, or the country of origin, is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For parasite identification in stool, ground truth would typically be established by experienced clinical microbiologists or parasitologists.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable. This device is a transport medium for specimens, not an AI or imaging diagnostic tool that would typically involve human readers interpreting images. Therefore, improvement of human readers with AI assistance is not relevant to this device.

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

• Standalone Performance: Not applicable. This is a specimen collection and transport medium, not an algorithm.

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

• Type of Ground Truth: While not explicitly stated, for a device used to detect intestinal parasites from stool specimens, the ground truth would most likely be established by a combination of:
  • Expert microscopic examination: Highly trained laboratory personnel identifying parasites directly.
  • Molecular methods: PCR or other genetic tests for specific parasites (if available and used as a gold standard).
  • Culture: For specific parasites that can be cultured.
    This document does not specify which methods were used.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. For a physical medical device like a transport medium, the concept of a "training set" as understood in machine learning is not directly applicable. If studies were performed to optimize the medium's composition or shelf-life, those would involve separate experimental designs, not a "training set" in the AI sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the AI sense. For the development and validation of the transport medium itself, "ground truth" would relate to its ability to preserve parasite morphology, viability, or antigenicity over time, which would be established through controlled laboratory experiments. These experiments would involve known positive and negative specimens and subsequent evaluation by appropriate diagnostic methods. However, the specific methodologies are not detailed in this clearance letter.

Summary of what can be gleaned from the document:

• Device Name: Par-One™
• Manufacturer: Remel Inc.
• Intended Use: "Recommended for use in qualitative procedures for the transportation, preservation, and examination of stool specimens for intestinal parasites. Concentration, permanent stained smear, and immunoassay procedures can be performed from this single vial transport system."
• Regulatory Status: 510(k) clearance, indicating "substantial equivalence" to a predicate device.
• Regulatory Class: Class I
• Product Code: LIO
• Prescription Use: Yes

The document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed study design and performance metrics typically found in a peer-reviewed publication or a comprehensive technical report for a device.

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