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The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.

The Circumplast is a device composed of two components, a transparent plastic conic tube, and a linen ligature. The device is sold sterile for single use, packaged in a sterile pouch. The Circumplast is available in four (4) sizes, to accommodate size of the infant's penis. The Circumplast is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare Practitioner fixes the patient's foreskin over the inner ring and then the prepuce is tied all around, over the groove of the bell, with a tight ligature. Skin forward of the crush line is trimmed away. After the procedure, the Circumplast device remains on the patient for 7 days. The Circumplast falls off after 3 - 7 days.

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.

Based on the provided document, the device in question is the Circumplast Circumcision Device.

Here's the analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it describes various non-clinical tests conducted and their pass status, implying that the acceptance criterion for each test was to pass it.

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

• Non-Clinical Performance Data: The document does not specify the sample sizes (e.g., number of devices tested) for the Compression, Tensile Strength, Torsion, Sterilization, and Biocompatibility tests. The data provenance is also not explicitly stated in terms of country of origin for these non-clinical tests. They are presented as general lab tests performed to support substantial equivalence.
• Clinical Performance Data:
  • Sample Size: Not specified. The document only states "Two clinical studies conducted."
  • Data Provenance: England and Australia (retrospective or prospective is not specified, but typically clinical trials are prospective).

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

This information is not provided in the document. The document describes non-clinical engineering tests and clinical studies, but it doesn't detail the process of establishing "ground truth" for a test set in the way one might for an AI/diagnostic device. For clinical studies, the "ground truth" would be derived from the patient outcomes and expert medical assessment during the study, but the specifics of how many experts were involved in evaluating these outcomes and their qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the focus is on non-clinical performance and a general statement about clinical safety and effectiveness, an explicit adjudication method for a "test set" as typically seen in diagnostic device evaluations (e.g., 2+1, 3+1 consensus) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable/provided. The device in question, the Circumplast Circumcision Device, is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed for this product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. As explained above, this device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Non-Clinical: The "ground truth" for the non-clinical tests (Compression, Tensile Strength, Torsion, Sterilization) is based on engineering standards and design specifications. For Biocompatibility, the ground truth is established by ISO 10993-1 standards.
• Clinical: The "ground truth" for the clinical studies, where safety and effectiveness were demonstrated, would be based on patient outcomes as assessed by healthcare practitioners in a clinical setting.

8. The Sample Size for the Training Set

This information is not applicable/provided. The concept of a "training set" is usually relevant for machine learning or AI models. For a physical medical device, the "training set" would arguably be the accumulation of engineering design iterations and preliminary testing, but the document doesn't provide specific sample sizes for these development stages.

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

This information is not applicable/provided for the reasons stated in point 8.

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