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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

• 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.

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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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Medical Maggots are indicated for debriding 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 accessory maggot confinement dressings, Creature Comforts™, and LeFlap™ and LeSoc™, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (see Figure 1)
Common names: Maggot dressings; green blow fly maggots; disinfected maggots; sterile maggots; therapeutic maggots; debriding maggots; maggot debridement therapy. Accessories: MDT dressings; maggot confinement dressings; maggot cage dressings.
"Proprietary" name: Medical Maggots; to be used with Creature Comforts or LeSoc (the latter being the new accessory featured in this Special PMN)

Maggot therapy is essentially a controlled wound myiasis (maggot infessation). The maggots macerate their food with their mouth hooks, release their digestive enzymes into the local environment, and ingest the liquefying and semi-solid tissue. As they grow, they molt twice. When satiated, the maggots leave their food source, burry themselves in a suitably protected area, and pupate. Adult flies emerge (eclose) approximately 1-3 weeks later. Maggot therapy dressings contain the medical grade larvae on the wound during the period of debridement, and facilitate easy and controlled removal when the patient and therapist determine they have completed their work.

The proposed modified accessory ("LeSoc") has the same basic structure and use as the previously approved "Sterile Nylon Stocking," with the exception that we will make the stocking out of a different polyester fabric: the same polyester monofilament fabric that we currently use in the production of our approved Creature Comforts dressing (our flat, non-stocking dressing). This means that the stocking weave will be fixed, not free to move or stretch.

The structure, function, technology and indications are the same as in the currently marketed products. The only difference will be the offering of a hybrid dressing accessory to create a stocking-like dressing out of our currently used fixed-weave polyester net instead of the stretch-weave polyester of our Sterile Nylon Stockings.

The provided text is a 510(k) summary for a medical device (Medical Maggots and maggot confinement dressings), specifically addressing a modification to an accessory (the "LeSoc" dressing). The document largely focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study report with specific acceptance criteria and performance metrics in the typical format for AI/ML device evaluations.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not present or applicable in this submission. This is common for predicate device submissions, where the focus is on showing the new device is as safe and effective as devices already on the market, often through addressing minor modifications and validating that the change does not negatively impact performance or create new risks.

Here's an attempt to extract and interpret the information provided, while noting where details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide quantitative acceptance criteria (e.g., "X% of maggots should not escape") or specific numerical performance metrics. The statements are qualitative affirmations of successful validation.

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

• Sample Size for Test Set: Not explicitly stated. The "Penetration & Durability Feasibility Study" is mentioned, but no sample size (e.g., number of dressing prototypes tested, number of maggots used) is given.
• Data Provenance: The studies appear to be internal validations performed by the manufacturer, Monarch Labs, LLC. There's no mention of external data or specific geographical origin beyond the company's location in Irvine, CA. The "Penetration & Durability Feasibility Study" and sterilization validation were performed by the manufacturer. Biocompatibility data was "supplied by manufacturer."
• Retrospective or Prospective: These appear to be prospective validation studies performed specifically for this 510(k) submission, confirming the performance of the modified accessory.

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

• Not applicable/Not mentioned. This type of information (expert consensus for ground truth) is typically relevant for diagnostic imaging AI/ML devices. For a physical medical device like this maggot dressing, the "ground truth" for the penetration and durability study would likely be directly observed maggot escape, not expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. Adjudication methods (like 2+1) are for resolving discrepancies in expert interpretations, which is not relevant for the types of studies described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This type of study is primarily for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant for this physical device.

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

• No, a standalone AI algorithm performance study was not done. This device does not incorporate an AI algorithm. The "device" itself is the physical maggot dressing and the biological maggots.

7. The Type of Ground Truth Used

• For Penitration & Durability: Direct observation of maggot escape (or lack thereof) from the dressing.
• For Sterilization Validation: Laboratory testing to confirm sterility parameters were met.
• For Biocompatibility: Results from standard biological evaluation tests (e.g., in vivo or in vitro tests using mice/cells) based on regulatory standards.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. This device does not involve a "training set" in the context of machine learning. The "training" for the maggots is their natural biological behavior, and the dressings are physical containment systems.

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

• Not applicable. See point 8.

Summary of Device and its Purpose based on the Text:

The device consists of "Medical Maggots" (Phaenicia sericata larvae) and associated confinement dressings. This submission focuses on a new dressing accessory called "LeSoc," which is a hybrid of existing approved dressings. The primary purpose of the maggots is debriding non-healing necrotic skin and soft tissue wounds. The dressings are to confine the maggots to the treatment area. The modification to the LeSoc dressing involves using a fixed-weave polyester fabric (similar to another approved dressing, "Creature Comforts") instead of a stretch-weave fabric (used in "Sterile Nylon Stockings") to prevent maggots from escaping. The studies described are validations of this material change, focusing on preventing maggot escape, ensuring proper sterilization, and confirming biocompatibility, to demonstrate substantial equivalence to previously cleared devices.

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Medical Maggots are indicated for debriding 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 accessory maggot confinement dressings, Creature Comforts and Creature Comforts II, are indicated for confining the medicinal maggots on the area of treatment during debridement therapy for the conditions mentioned above.

Phaenicia sericata larvae (Medical Maggots) and maggot confinement dressings (Creature Comforts and Creature Comforts II). The maggots are used for debridement of non-healing necrotic skin and soft tissue wounds. The dressings are used to confine the maggots on the wound. The modified accessory is a pre-assembled version of the hydrocolloid-netting cage.

This 510(k) submission describes a modification to an existing device, "Medical Maggots," which involves a pre-assembled version of their confinement dressing, "Creature Comforts II." As such, the submission does not contain extensive new clinical study data or detailed acceptance criteria for a novel device. Instead, it focuses on demonstrating substantial equivalence to the previously cleared device and ensuring the modification does not negatively impact safety or efficacy.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria in a table format, nor does it present detailed performance metrics for the modified device in comparison to such criteria. This is typical for a 510(k) modification where the fundamental product (the maggots) and its intended use remain unchanged. The core argument is substantial equivalence, not a new performance claim against defined thresholds.

Instead, the submission refers to:

• Safety and Efficacy Data (for the predicate device): "All complaints and adverse events are collected and reviewed (phase 4 post-marketing study), along with solicited and unsolicited client comments. Analysis of this data recently revealed that there were 43 complaints and adverse events (AE) reported over the prior 2 years in association with 4,506 vials of maggots... making an AE rate of about 0.95% of vials distributed."
• Improvement with "Creature Comforts II": The new dressing aims to "reduce the unferences rounding from this docessory from the parties and the opportunity for escaping maggots." This implies an acceptance criterion related to maggot containment and ease of use, though no specific metrics are given.

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

• Test Set (for the modified accessory): The document does not describe a formal head-to-head clinical "test set" for the "Creature Comforts II" dressing with specific sample sizes. The modification is primarily a design change to address existing issues.
• Data Provenance (for the predicate device's post-market surveillance): The data on adverse events (43 complaints over 2 years for 4,506 vials) is from a retrospective, post-marketing study ("phase 4 post-marketing study") based on "all complaints and adverse events...along with solicited and unsolicited client comments." The country of origin is not explicitly stated, but given Monarch Labs is US-based and this is an FDA submission, the data is likely predominantly from the United States.

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

Not applicable to this submission. The submission does not describe a clinical study for the modified device that required expert consensus for ground truth. The adverse event data relies on client reports, not expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable to this submission. There is no described test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported for this device. This device is a medical product (larvae for debridement) and its associated dressing, not an imaging or diagnostic device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study (algorithm only) was not done. The device (Medical Maggots) is a biological product, and its effectiveness is inherently tied to its biological action on a wound, in conjunction with human application and monitoring. The "Creature Comforts II" is a physical dressing.

7. Type of Ground Truth Used

• For the predicate device's efficacy/safety: The original "Medical Maggots" were tested for safety and efficacy in "laboratory and clinical trials 1990-1995" (Section 7). The specific type of ground truth used in those original trials is not detailed in this 510(k) summary, but for wound debridement efficacy studies, it would typically involve clinical assessments (e.g., wound area reduction, necrotic tissue removal) potentially supported by photographic evidence or pathological examination if biopsies were taken.
• For the current modification: The "ground truth" for identifying issues with the original dressing leading to the modification was client complaints and adverse event reports related to transportation, viability, and challenges in local assembly leading to potential maggot escape (Section 5).

8. Sample Size for the Training Set

Not applicable. The submission does not describe a machine learning algorithm or an AI component that would require 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 algorithm.

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For debriding 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.

Not Found

This document is a 510(k) clearance letter for "Medical Maggots" and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device for specific indications for use, but it does not detail any performance metrics or clinical study results.

Therefore, I cannot provide the requested information based on the provided text.

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