Search Results

The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.

The InTray GC is a Modified Thayer-Martin medium within a sealed inner well. The inner seal covers the inner well containing agar and an additional sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and inoculates the surface of the medium with the patient sample followed by resealing the outer adhesive label. High humidity within the InTray causes the tablet to generate CO2 thus providing adequate bacterial growth condition for the target pathogen. After incubation of the inoculated InTray, the bacterial growth can be observed through the window without opening the InTray and therefore not disturbing the established CO2 concentration. Observation of culture growth can be by eye, hand lens or microscope.

The provided text is a 510(k) summary for the InTray® GC device, a culture medium for pathogenic Neisseria spp. The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core of the study is to demonstrate the InTray GC device's performance, particularly its newly claimed transport function, is acceptable and substantially equivalent to its predicate device (K993033). The primary metric for acceptance appears to be the recoverability of Neisseria gonorrhoeae after inoculation, transport simulation, and incubation.

Implied Acceptance Criteria and Reported Performance:

Study Details:

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

   • Transport Simulation Study:
     • Sample Size: "Four InTray replicates were inoculated with approximately 20 colony forming units (CFU) for each experimental group outlined in the table below and the process was repeated with the five different AR isolate bank strains (N. gonorrhoeae strains 0165, 0202, 0175, 0181 & 0197) and N. gonorrhoeae strain ATCC 43069." This means for each of the 6 strains, there were 4 replicates per experimental group (A, B, C1, C2, C3). If considering only Group A for the 72-hour transport claim, that would be 6 strains * 4 replicates = 24 samples.
     • Replicates for comparative assessment: "Multiple lots of variously aged InTray GC devices were used to test the six strains of N. gonorrhoeae, with 3 lots testing 5 strains (N=15 replicates) and two different lots testing one of the six strains (N=2 replicates)." This totals 17 replicates for the InTray GC in the comparative assessment. For the legally marketed transport device, "Three replicates of the legally marketed transport device were used to inoculate the same six N. gonorrhoeae strains". This totals 18 replicates for the comparator device.
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a medical device's performance validation, it is almost certainly prospective laboratory-based study data, generated specifically for this submission by Biomed Diagnostics Inc. ("Biomed Diagnostics Inc. performed data analysis on the recoverability...").

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

   • The study focuses on the biological performance of the culture medium regarding the growth and recovery of N. gonorrhoeae. The "ground truth" here is the actual growth/recovery of bacteria, measured in CFU/mL. This is an objective, quantitative biological outcome by the device itself, rather than a subjective interpretation by human experts.
   • Therefore, the study does not involve human experts establishing a "ground truth" in the same way an imaging AI study would use radiologists. The measurements are taken directly from laboratory cultures.
   • The "experts" involved would be the laboratory personnel performing the inoculations, incubations, and CFU counts, who would be qualified microbiologists or lab technicians. Their specific number or qualifications are not detailed in the summary, as is typical for this type of performance study where method reproducibility rather than expert consensus is key.

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

   • No adjudication method (like 2+1, 3+1 for expert review) is mentioned or applicable. This is a laboratory performance study measuring bacterial growth, not a clinical study involving human interpretation of results requiring adjudication of discrepancies. The "ground truth" is measured objectively via CFU counts.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. This device is a culture medium, not an AI-assisted diagnostic tool interpreted by human readers. The comparative study was between the InTray GC device and a "legally marketed transport device" in terms of bacterial recovery, not human reader performance.

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

   • This question is not applicable in the context of this device. The InTray GC is a biological culture medium, not an algorithm. Its performance is inherent in its ability to support bacterial growth.

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

   • The ground truth used is objective quantitative microbiology data: colony forming unit (CFU/mL) counts of Neisseria gonorrhoeae strains, which indicate the viability and recovery of the bacteria under different transport and incubation conditions. Visual observation of "increased colony size" also serves as a qualitative ground truth for growth.

7. The sample size for the training set:

   • This is a device performance study, not a machine learning model. Therefore, there is no training set in the sense of data used to train an algorithm. The data presented is for validation testing.

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

   • Not applicable as there is no training set for an algorithm. The "ground truth" for the performance studies was established through controlled laboratory inoculation of specific N. gonorrhoeae strains and subsequent quantitative (CFU counts) and qualitative (colony size/presence of growth) assessment.

Ask a specific question about this device

InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.

The InTray GC contains a Modified Thayer-Martin (MTM) medium within a sealed inner well. It has a two inch diameter well and 5-6ml of media. The inner seal that covers this well also covers another sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and reseals this outer label. In practice, when the user opens the outer seal, he may then remove and discard the inner seal exposing the surface of the medium and the sealed cavity. The next step is to inoculate the surface of the medium with the patient sample. Next, puncture the seal over the cavity with any convenient sharp point. Finally, reseal the outer label over the InTray. High humidity within the InTray causes the tablet to generate CO2. Incubate the InTray and observe the growth of organisms through the window without opening the InTray and therefore without disturbing the atmosphere. Observation can be by eye, hand lens or microscope. This packaging has been used since 1994 for other BioMed media products.

The provided text describes a 510(k) premarket approval for the BioMed Diagnostics Incorporated's InTray GC for the isolation of pathogenic Neisseria. The submission details both laboratory and clinical studies to demonstrate its performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or colony counts. However, the study aims to demonstrate that InTray GC performs comparably to or better than existing commercial media. The implicit acceptance criteria appear to be:

• For the other two N. gonorrhoeae strains, colony counts were about half compared to fresh commercial media.
  - In no case was there failure to recover the organism. |
  | Suppression of competing organisms (e.g., N. sicca, E. coli, S. epidermidis, P. mirabilis, C. albicans) | - After one year at room temperature, the InTray GC was superior to fresh commercial media in suppressing growth of these organisms. |
  | Shelf life | - Demonstrated performance after "one year at room temperature." (Superior in suppressing contaminants after one year at room temperature. Implied adequate for N. gonorrhoeae recovery after one year as well, as tested.) |
  | Clinical Study: | |
  | Agreement with commercially prepared media for N. gonorrhoeae detection | - Results positive for N. gonorrhoeae were identical to those for commercially prepared media: 18 positive, 210 negative. |
  | Reduction of contaminants (clinical samples) | - The principal contaminant was C. albicans.
• 17 positive for the InTray GC (for C. albicans)
• 30 positive with the comparison MTM medium (for C. albicans).
• This indicates superiority of InTray GC in suppressing C. albicans in a clinical setting. |
  | Safety (no adverse indications) | - There were no adverse indications in these tests. |

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

• Laboratory Study:

  • Test Set Organisms: Pure cultures of four strains of N. gonorrhoeae (including NCCLS standard strain and an AHU auxotype) and several competing organisms (N. sicca, E. coli, S. epidermidis, P. mirabilis, C. albicans).
  • Sample Size: Not explicitly stated as a number of distinct samples for each culture, but described as tests performed using "pure cultures at 10^2 cfu for each of four strains of N. gonorrhoeae and at 10^5 cfu for competing organisms." It also mentions "two one-year studies." This implies multiple tests over time for each organism.
  • Data Provenance: The N. gonorrhoeae strains were drawn from a "world-wide data base." The study was performed "in the laboratory."
  • Retrospective/Prospective: The laboratory studies sound prospective in design, carefully controlled experiments designed to test the media's performance over one year.

• Clinical Study:

  • Test Set Sample Size: 228 female patients.
  • Data Provenance: Clinical study using cervical swabs. The country of origin is not specified, but typically for 510(k) submissions, clinical data is often from the US or a region with comparable medical standards.
  • Retrospective/Prospective: This was a prospective clinical study, comparing the InTray GC to commercially prepared media.

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

The document does not provide details about experts for establishing ground truth in the traditional sense of consensus or adjudication for image-based or diagnostic interpretation.

• For the laboratory study, the "ground truth" for organism identification and colony counts would have been established by standard microbiological methods, likely performed by trained microbiologists.
• For the clinical study, the "ground truth" for N. gonorrhoeae positivity and the presence of C. albicans would have been established by the comparison to "commercially prepared media," which serves as the reference standard in this context. It's implied that clinical laboratory personnel would have read these results, but their qualifications are not specified.

4. Adjudication Method for the Test Set

Not applicable. This device is a culture medium, and the "ground truth" is determined by the growth or non-growth of specific organisms, not by interpretive reads that would require adjudication among experts. The comparison is directly to a reference method (commercial media).

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 not an AI-assisted diagnostic device, nor is it an imaging device requiring human reader interpretation in the context of an MRMC study. It's a culture medium.

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

Not applicable. This device is a culture medium, not an algorithm. Its performance is inherent to the medium itself.

7. The Type of Ground Truth Used

• Laboratory Study: Microbiological culture standards (known pure cultures at specific CFUs), and comparison to fresh commercial MTM and chocolate media.
• Clinical Study: Comparison to "commercially prepared media" (presumably reference MTM or other standard culture methods for N. gonorrhoeae). The results were compared for agreement on positive and negative cases.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a distinct training set. The "training" for such a product would be its development and formulation, not data feeding to an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Ask a specific question about this device

Ask a specific question about this device