(145 days)
An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
Medicinal Leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations.
This 510(k) premarket notification for Medicinal Leeches (Hirudo Medicinalis) primarily establishes substantial equivalence based on the device's historical use and documented value as a "preamendment device" rather than presenting a traditional study with acceptance criteria and performance metrics against a newer, classified predicate.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in the given document.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. This submission is for a preamendment device, relying on historical use and documented value rather than specific performance metrics against a classified predicate. | "An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding." |
The document highlights their use since ancient Egypt and their re-adoption in modern surgery to restore venous blood circulation, producing anticoagulant and vasodilator substances that allow continued bleeding and improve venous circulation. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not provided. The submission does not describe a "test set" in the conventional sense of evaluating a new device against a specific set of data.
- Data Provenance: The document refers to the historical use of medicinal leeches as far back as ancient Egypt and their revival in modern surgical practice. This suggests a reliance on retrospective, long-standing clinical experience and historical documentation rather than a specific prospective study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The submission focuses on the historical use and established value of leeches, which does not involve establishing ground truth for a discrete test set by a panel of experts in the context of a new device evaluation.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set requiring expert adjudication is described.
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 is not an AI/software device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a biological device (medicinal leeches), not an algorithm or software. Its performance is inherently "standalone" in the sense that the leeches act directly, but not in the context of a computational algorithm.
7. The type of ground truth used
- The "ground truth" for the efficacy and safety of medicinal leeches in this context is based on historical clinical use, documented medical practice over centuries, and established physiological effects (anticoagulant and vasodilator properties, prolonged localized bleeding). This is essentially outcomes data and expert consensus accumulated over extended historical periods, rather than a singular, prospectively established ground truth for a specific study.
8. The sample size for the training set
- Not applicable/Not provided. There is no machine learning component to this device, and thus no "training set" in the computational sense. The "training" here refers to centuries of human experience and medical observation.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, there is no computational training set. The effectiveness is derived from historical and ongoing clinical observation and medical understanding of their biological mechanisms.
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