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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 postsurgical wounds.

The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 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 Larval Debridement Therapy Products - Larvae 100/200/300 and BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided either loose or within a sterile bag, respectively. The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into sterilized transport tubes or sterilized bags which are then placed into sterile transport tubes. These tubes are additionally pouched and 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 modification to these products consists of replacing the feed used for stock flies from liver to a special mixture of nutrients called the "Carnival Diet". The Carnival Diet is also used to rear new fly generations and as a medium to induce egg laying. The reason for changing to this feeding material is to reduce the risk of transmission of viruses by removing the use of unprocessed animal organs and change to using pharmaceutical-grade animal-derived material.

The provided text describes a 510(k) premarket notification for a medical device: BIOMONDE LARVAL DEBRIDEMENT THERAPY PRODUCTS. This notification is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested points, particularly those related to AI/ML specific studies, ground truth establishment, expert adjudication, and comparative effectiveness studies, are not applicable or cannot be extracted from this document, as the device is not an AI/ML device.

However, I can extract information regarding the device itself, the modification, and the non-clinical testing performed to establish substantial equivalence.

Here's the breakdown of the information that can be extracted, and where the requested points are not applicable:

Device Description and Modification:

• Device Name: BIOMONDE LARVAL DEBRIDEMENT THERAPY PRODUCTS, LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400
• Device Type: Live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided either loose or within a sterile bag.
• Modification: Replacement of the feed used for stock flies from liver to a special mixture of nutrients called the "Carnival Diet". The reason for this change is to reduce the risk of transmission of viruses by removing the use of unprocessed animal organs and changing to pharmaceutical-grade animal-derived material.

Acceptance Criteria and Device Performance (Non-Clinical for Substantial Equivalence)

The acceptance criteria here are derived from the need to demonstrate that the modified product (using the "Carnival Diet") performs equivalently to the predicate devices (using liver feed) in terms of established performance metrics for fly colony health and larval debridement activity.

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

• Sample Size: Not explicitly stated as a number of larvae or flies in quantifiable terms. The testing involved "five (5) generations" of flies and larvae for the Carnival Diet group, compared to a "control" group fed liver.
• Data Provenance: The study was conducted by BioMonde, a trading name of ZooBiotic Limited, based in the United Kingdom. This would be considered internal, prospective testing for the purpose of this 510(k) submission.

2. 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. This is a non-clinical, laboratory-based study for a physical device (live larvae), not an AI/ML device requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for these tests are direct measurements of biological and performance characteristics.

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

• Not Applicable. No human adjudication of a test set is relevant for this type of non-clinical, laboratory-based study.

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

• Not Applicable. This is not an AI/ML device, and no MRMC study was performed.

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

• Not Applicable. This is not an AI/ML device.

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

• Ground Truth: For the non-clinical performance testing, the "ground truth" was established through direct observation and measurement of biological parameters (larval duration, pupae weight, pupae hatch success, egg yield) and direct measurement of debridement activity (protein consumption assay) and biochemical analysis (enzyme patterns). These are objective laboratory measurements, not subjective expert consensus.

7. The sample size for the training set

• Not Applicable. This is not an AI/ML device, and therefore does not have a training set in the AI/ML context. The "training" for the flies was the adaptation to the Carnival Diet over sequential generations.

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

• Not Applicable. As above, no AI/ML training set is involved. The "ground truth" for establishing satisfactory performance over generations would be the consistent achievement of the biological and debridement performance metrics outlined in the table above after the adaptation period.

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The BioMonde Larval Debridement Therapy Products - BioBag 50/100/200/300/400 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post-surgical wounds.

The BioMonde BioBag 50/100/200/300/400 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata, provided within a sterile bag. They are manufactured in five (5) configurations:

• BioBag 50: at least 50 larvae per container
• BioBag 100: at least 100 larvae per container
• BioBag 200: at least 200 larvae per container
• BioBag 300: at least 300 larvae per container
• BioBag 400: at least 400 larvae per container
  The larvae are derived from disinfected fly eggs. The BioBags are open mesh polyester bags that come in a variety of sizes based on the dose (number) of larvae to be used. The bags are used to constrain the larvae, preventing them from migrating from the wound. The bags also contain sterile PVA foam cubes that serve as spacers' in the BioBags to allow free movement of the larvae within the mesh bag.
  Larvae are transferred under controlled manufacturing conditions into sterilized bags after which they are placed into sterile transport tubes which are additionally pouched and boxed for transport. Upon arrival at the treatment location, the BioBags are applied to the wound and covered with permeable and absorbent dressings (not provided).

The provided document is a 510(k) summary for a medical device (BioMonde Larval Debridement Therapy Products - BioBag). This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study that involves human readers or AI in a clinical setting. Therefore, many of the requested elements are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that samples of free-range Larvae300 (parent device), the BioBag100 (modified device), and empty bags (control) were tested "in triplicate." This means there were 3 samples for each of the three groups (loose larvae, bagged larvae, control), for a total of 9 test samples in the activity assay.
• Data Provenance: The study was a non-clinical, in-vitro laboratory test performed by BioMonde. The location of the testing is not explicitly stated in this summary, but BioMonde's contact address is in the United Kingdom.

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

Not applicable. This was a non-clinical performance test measuring tissue consumption by larvae, not a study involving human experts establishing ground truth for medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. There was no human expert adjudication of results in this non-clinical performance test. Performance was measured objectively (mass consumed).

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 document describes a non-clinical performance study of larval debridement therapy, not an MRMC study comparing human reader performance with and without AI assistance.

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

Not applicable. This is not an algorithm or AI device. The "performance" being evaluated is the biological activity of live maggots.

7. The type of ground truth used

The ground truth for the non-clinical performance study was based on:

• Objective measurement: The actual wet and dry mass of dead tissue consumed by the larvae.
• Scientific literature: The 30g/5.53g consumption target for the second acceptance criterion was derived from Blake et al., 2007, which established a benchmark for maggot debridement activity.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As there is no training set for an AI/ML model, no ground truth needed to be established for it.

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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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