(103 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Modified Product with Carnival Diet) |
|---|---|
| Fly Colony Health & Fitness Parameters: | |
| 1. Larval duration (comparable to predicate) | "appears to be slightly smaller in size" |
| 2. Pupae weight (comparable to predicate) | "appears to be slightly smaller in size" |
| 3. Pupae hatch success (comparable to predicate) | "as healthy...as those derived from flies reared on liver" |
| 4. Egg yield (comparable to predicate) | "as healthy...as those derived from flies reared on liver" |
| Larval Debridement Activity: | |
| 1. Larval Activity Assay (consumption of protein by a set number of larvae over a 2-day period in a defined apparatus - comparable to predicate) | "as effective in terms of debridement activity as those derived from flies reared on liver" |
| 2. Enzyme pattern of larval secretions (no difference compared to predicate) | "No difference in enzyme patterns was found between the control and the Carnival Diet groups." |
| Adaptation Period: Satisfactory performance across generations after diet change | "Testing across generations indicates that adaptation to the Carnival Diet over at least 3 generations is necessary to assure satisfactory performance." |
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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