(120 days)
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
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| First Criterion: Clearly observable differences between the wet and dry mass consumed (in grams) for the loose and bagged larvae test samples when compared to a control group of BioBags with no larvae. | Analysis of the mean values of both dry and wet mass consumed showed that the average mass consumed per 100 larvae for both loose and BioBag larvae product configurations was "much greater" than that of the control group (empty bags). The results for the bagged larvae were "much closer" to that of the loose larvae than the control. The document implies this "clearly observable difference" was demonstrated as mass consumed by larvae (bagged and loose) was significantly higher than the control where no larvae were present. |
| Second Criterion: Both the BioBag (modified device) and loose larvae (predicate device) product consume at least 30g of wet tissue over a 48-hour experiment per Blake et al., 2007 (equivalent to at least 5.53g of dry tissue). | Wet Weight: |
- BioBag (modified device): 36.01g
- Loose larvae (predicate device): 46.11g
Both values are greater than the 30g wet tissue target.
Dry Weight:
- BioBag (modified device): 7.89g
- Loose larvae (predicate device): 12.38g
Both values are greater than the 5.53g dry tissue target. |
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.
N/A