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The BioMonde Larval Debridement Therapy Products – Larvae 100/200/300 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds.

The BioMonde Larvae 100/200/300 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata. They are manufactured in three (3) configurations:

• Larvae100: at least 100 larvae per container
• Larvae200: at least 200 larvae per container .
• Larvae300: at least 300 larvae per container .
  The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into transport tubes which are additionally boxed for transport. Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided).

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/imaging-based devices. This submission for the BioMonde Larval Debridement Therapy Products (Larvae 100/200/300) is a 510(k) Premarket Notification based on substantial equivalence to a predicate device, not on meeting predefined performance metrics from a device-specific study.

Here's a breakdown of why this information is missing and what the document does say:

1. Type of Device: This is for a biological product (live larvae for debridement), not an AI algorithm or an imaging device. The regulatory pathway is different.
2. Regulatory Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing technical characteristics and performance to the predicate, rather than establishing de novo performance criteria.
3. No Clinical Study: The document explicitly states: "No clinical data were included in this 510(k) Premarket Notification."
4. No Standalone Algorithm Performance: As this is not an algorithm, this concept is not applicable.
5. No MRMC Comparative Effectiveness Study: Also not applicable for this type of product.

Therefore, many of the requested fields cannot be filled based on the provided text.

However, I can extract the relevant information regarding the basis for substantial equivalence:

Basis for Substantial Equivalence:

Here's the breakdown of the other requested information, noting where it's not applicable or available:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document, as this is a substantial equivalence submission. The implicit acceptance criterion is "substantially equivalent" to the predicate device in terms of intended use, indications, technological characteristics, and performance.
   • Reported Device Performance: The primary performance reported is that "side by side testing of the performance of the BioMonde product and the predicate demonstrates substantial equivalence in performance." No specific metrics (e.g., debridement rate, time to healing) are provided, only that it is equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size for Test Set: Not specified. The document only mentions "side by side testing" without detailing the study methodology, sample size, or study design (e.g., animal models, in vitro, specific wound types).
   • Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. This device is a therapeutic product, not a diagnostic or AI device requiring expert ground truth for imaging or similar interpretations. The "ground truth" for its performance would typically relate to biological activity (e.g., debridement effectiveness), which would be measured directly.

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

   • Not applicable/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:

   • No, an MRMC study was not done. This is not an AI-assisted diagnostic device for human readers.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable/Not provided in the sense of establishing 'ground truth' for an AI model. For the performance testing, the "ground truth" would be direct measurements of the debridement activity or other biological effects compared to the predicate device. The document only states "side by side testing of the performance."

8. The sample size for the training set:

   • Not applicable. This is not an AI product requiring a training set.

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

   • Not applicable.

In summary, this 510(k) relies on demonstrating equivalence to a predicate device through non-clinical testing of technical and performance characteristics, rather than establishing novel performance metrics or engaging in clinical trials to meet specific, predetermined acceptance criteria.

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