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Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.

The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.

This document is a 510(k) summary for a medical device called "Medicinal Leech" (K140907). It outlines the substantial equivalence determination for marketing the device.

Based on the provided text, the device is a Medicinal Leech, classified as Unclassified with product code NRN.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

This document describes a medical device, a Medicinal Leech, which is a biological entity. The FDA's substantial equivalence review for such a device does not typically involve traditional "acceptance criteria" based on quantitative performance metrics like sensitivity, specificity, or accuracy, as would be seen for an AI/software device. Instead, the review focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.

The "performance" of the medicinal leech is described in terms of its function and therapeutic benefits, rather than specific numerical acceptance criteria.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical trials or performance studies with a specific sample size. The FDA review for this device is based on demonstrating substantial equivalence to existing legally marketed predicate devices. This typically involves comparing characteristics, indications for use, and safety/effectiveness profiles rather than presenting de novo clinical study data for acceptance criteria.

Therefore, there is no explicit test set sample size or data provenance described for this 510(k) submission. The "data" provenance would implicitly be from the history of use and the regulatory approvals of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there is no "test set" or ground truth established in the sense of a clinical or image-based diagnostic performance study for this type of device. The ground truth, if one could apply the term, would be the established medical consensus on the therapeutic utility and safety profile of medicinal leeches, which has been accumulated over centuries of use and recognized in prior regulatory approvals.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no specific test set requiring adjudication in this regulatory submission.

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 device is a medicinal leech, a biological product, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This refers to AI/software performance, which is not relevant to a medicinal leech.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" is implicitly the established safety and effectiveness profile of legally marketed predicate medicinal leech devices, supported by historical medical use and scientific understanding of their physiological effects. This is a form of historical medical consensus and clinical experience, rather than a specific, newly generated type of ground truth data (like pathology or outcomes from a new clinical trial).

The study that proves the device meets the acceptance criteria (Substantial Equivalence):

The "study" here is not an experimental clinical trial, but rather a comparative analysis demonstrating substantial equivalence to predicate devices.

The document states:

• "Carolina Biological Supply Company (Carolina) will normally obtain and offer medicinal leeches that are identical to those approved under K132958, with scientific name Hirudo verbana."
• "If necessary, Carolina may obtain (from a registered source with an approved and registered device) and offer medicinal leeches with scientific name Hirudo medicinalis, as are approved under K040187."
• "Carolina's product is identical to predicate devices."

The listed predicate devices are:

• K040187: Ricarimpex SAS, Medicinal Leeches (Hirudo Medicinalis), Approved 06-21-04
• K132958: Biopharm (UK) Ltd, European Medicinal Leeches (Hirudo Verbena), Approved 02-19-14

Proof of Meeting Acceptance Criteria:
The core of the submission (and the "study" by regulatory standards here) is the assertion and demonstration that the characteristics, indications for use, and operational aspects (facilities, handling, packaging, storage, disposal) of the Carolina Biological Supply Company's Medicinal Leeches are substantially equivalent to those of these two legally marketed predicate devices. By proving they are "identical" in all relevant aspects to already-approved devices, the manufacturer demonstrates they meet the implicit safety and effectiveness "acceptance criteria" established by the predicates.

8. The sample size for the training set

Not applicable. This is not an AI/software device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

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Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.

The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.

This document is a 510(k) summary for Biopharm (UK) Ltd.'s Medicinal Leeches (Hirudo verbana). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device (K040187, also for Medicinal Leeches, but classified as Hirudo medicinalis).

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would expect for a diagnostic or therapeutic medical device with measurable outcomes. This is because Medicinal Leeches are a "Preamendment Device - Unclassified." This means they were marketed prior to May 28, 1976 (the enactment date of the Medical Device Amendments) and as such, they are not subject to the same regulatory requirements for performance testing, clinical trials, or established acceptance criteria as newly developed devices.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

Instead of performance criteria and a study to meet them, the submission focuses on:

• Intended Use: Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches can be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
• Mechanism of Action: The saliva of the leech contains an anticoagulant (Hirudin) which is responsible for the prolonged bleeding that occurs after the leech has detached. This prolonged bleeding is used in instances where blood has become congested.
• Substantial Equivalence: The key "study" here is the comparison to a predicate device. The document states: "Our device and its predicate share the same characteristics, they are both European Medicinal Leeches... The only difference is that our device is scientifically categorized as the species Hirudo verbana (Southern European Medicinal Leeches) and the predicate is classified as Hirudo medicinalis (Northern European Medicinal Leeches). ... There are no known differences in the activity spectrums of the two European variants. The two medicinal leech species are used as exact equivalents for use in overcoming problems with venous congestion."

Therefore, I cannot provide the requested table and study details as they do not exist in the context of this 510(k) submission for a preamendment, unclassified device. The "acceptance criteria" were effectively met by demonstrating substantial equivalence to an existing legally marketed device and its accepted indications for use, without the need for a rigorous performance study with numerical targets.

If new performance data were required for this type of device, it would indicate a reclassification or a new regulatory pathway, which is not the case here.

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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

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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