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The AMS Ambicor Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in men who, after appropriate patient history, diagnostic evaluation and discussions with the urologist of other alternative treatment methods, are determined to be suitable candidates for implantation surgery.

The Ambicor Penile Prosthesis is a device intended for implantation in the body to correct erectile impotence. The device consists of two cylinders and a single pump. The cylinders are implanted in the corpora cavernosa of the penis and a pump which is implanted in the scrotum. Each time the pump bulb is squeezed, saline is pumped from the reservoir into the cylinders. This step produces the inflation that makes the penis rigid. The Ambicor Penile Prosthesis is deflated by bending the penis (and specifically, the cylinders) to a 55 - 65° angle and maintaining that position for 6-12 seconds before releasing. The device comes with 12 rear tip extenders (RTE). Each RTE provides 0.5 cm of additional length to the device. A total of 12 RTEs are packaged with each device, potentially providing an additional 3.0 cm of length expansion per cylinder (6 RTEs/cylinder). The device consists primarily of silicone elastomers, incorporates polyester fabric, an expanded polytetrafluoroethylene (PTFE) sleeve, a polyacetal, and stainless steel components.

This document describes the AMS Ambicor™ Penile Prosthesis and its comparison to a predicate device, focusing on a material change from Delrin to Texapol components. The submission aims to demonstrate substantial equivalence, rather than establishing acceptance criteria for a new device's performance against a disease or condition. Therefore, the information requested about acceptance criteria and a study proving the device meets those criteria (in the context of clinical outcomes or diagnostic accuracy) is not directly applicable to this type of regulatory submission.

However, based on the provided text, we can interpret "acceptance criteria" through the lens of substantial equivalence for this material change, and describe the "study" as the bench testing and material comparison performed.

Here's an analysis structured per your request, adapting the terms to fit the available information:

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

Since this is a submission for a material change demonstrating substantial equivalence, the "acceptance criteria" are implicitly defined by the properties of the predicate device (AMS Ambicor with Delrin components). The "reported device performance" refers to the AMS Ambicor with Texapol components meeting these established properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a "sample size" in the context of clinical patients or a large number of devices for statistical analysis. The "test set" here refers to the Texapol components themselves and devices fabricated with them for bench testing. The number of components or devices tested is not provided.
• Data Provenance: The data appears to be generated internally by American Medical Systems as part of their regulatory submission a prospective evaluation of the new Texapol material and devices manufactured with it. No country of origin for specific testing data is mentioned beyond the company's US address.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not applicable in this context. The "ground truth" for this submission is the established performance and material properties of the predicate device (Delrin components). The evaluation is a technical comparison by the manufacturer's engineers and scientists, rather than an expert medical consensus on a clinical outcome.

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

• Adjudication Method: Not applicable. This regulatory submission is a direct comparison of material properties and components, not a clinical trial requiring adjudications for diagnostic or treatment outcomes.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a penile implant, not a diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

• Standalone Performance: Not applicable. This device is a mechanical implant; there is no "algorithm only" or "human-in-the-loop" performance associated with its function or evaluation in this document.

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

• Type of Ground Truth: The "ground truth" for this submission is the established performance and material specifications of the previously cleared predicate device (AMS Ambicor with Delrin components), as well as general scientific and engineering principles for material suitability in medical devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a new material for an existing device, not an AI/ML algorithm that requires a "training set."

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

• Ground truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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