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The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.

The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.

The provided submission does not contain specific acceptance criteria or a detailed study proving the device meets these criteria. Instead, it is a 510(k) summary focused on establishing substantial equivalence to predicate devices. The document outlines the intended use, device description, and a comparison table with predicate devices, but lacks quantitative performance metrics or a formal study design for evaluating the LEM Hemorrhoidal Ligators' performance against predefined acceptance criteria.

The core of this submission is a comparison of the new device (LEM Hemorrhoidal Ligators) to existing, legally marketed devices (O'Regan Ligator and Erchinger Hemorrhoidal Ligator) to demonstrate that it is "substantially equivalent." This means that the device is as safe and effective as the predicate devices.

Here's an analysis of the provided text in relation to your request, with explicit mention of what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or qualitative performance targets that the device had to meet (e.g., success rate of banding, complication rates, force required, band retention force, etc.).
• Actual performance data from a study against such criteria. The document only describes the device's features and its similarity to predicate devices.

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

• Sample Size for Test Set: Not applicable / Not reported.
• Data Provenance: Not applicable / Not reported.

Explanation: This 510(k) summary does not describe a clinical performance study with a "test set" in the sense of patient data. The evaluation is based on a comparison to predicate devices, focusing on design, materials, and intended use. There is no mention of country of origin for any (non-existent) test data or whether it was retrospective or prospective.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is mentioned.

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

• No. The document does not describe an MRMC study or any study comparing human readers' performance with or without AI assistance. This device is a mechanical ligator, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This device is a mechanical medical instrument, not an algorithm. Therefore, a standalone (algorithm only) performance study is irrelevant.

7. Type of Ground Truth Used

• Not applicable. As there is no test set or clinical study described in detail, the concept of "ground truth" (e.g., pathology, outcomes data) for evaluation is not presented. The "ground truth" equivalent in a 510(k) is often the established safety and effectiveness of the predicate devices against which the new device is compared.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" with established ground truth.

Overall Conclusion:

The provided document is a 510(k) premarket notification summary. For such submissions, the primary "study" is often a comparison to predicate devices, demonstrating substantial equivalence rather than conducting a de novo clinical trial with specific performance acceptance criteria. The document focuses on demonstrating that the LEM Hemorrhoidal Ligators have the "same intended use" and "similar technological characteristics" to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. Therefore, many of the detailed study-related questions you posed are not applicable to the content of this specific regulatory submission.

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