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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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