(97 days)
The AMS Spectra™ Concealable Penile Prosthesis is a sterile, nonpyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.
The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials.
The cylinder consists of a malleable section of articulating polymer segments. A cable extends through the center of the articulating segments. The proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone.
The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse.
Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm.
The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length.
Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012.) These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.
The AMS Spectra™ Concealable Penile Prosthesis did not include a clinical study. The device's acceptance criteria and performance were established through non-clinical performance tests, comparing it to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cycle Life | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Springback Angle | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Column Strength (Rigidity) | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Bend Force | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Bond Strength | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Packaging | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Sterilization | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Biocompatibility | Not explicitly stated, but implied to meet predicate. | Met acceptance criteria. |
| Cadaveric Evaluation | Not explicitly stated, but implied to be satisfactory. | Undertaken with physicians, implying satisfactory performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. The tests were performed on the "Spectra™ product," which refers to the device itself.
Data Provenance: The data is from non-clinical performance tests conducted by American Medical Systems Inc. (AMS). These are laboratory tests and a cadaveric evaluation, not data from human subjects. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the cadaveric evaluation, "physicians" were involved. The specific number and qualifications (e.g., Urologist, years of experience) are not provided in the document. For the other non-clinical tests (cycle life, strength, etc.), ground truth was established by engineering specifications and industry standards relevant to the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This was not a human observer study requiring an adjudication method. The non-clinical tests involved objective measurements against a predetermined, internal acceptance criterion.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device is a physical implant, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the AMS Spectra™ Concealable Penile Prosthesis is a physical medical device, not an algorithm or AI. It does not perform a diagnostic or interpretive function that would require "standalone" performance evaluation in that context. The "standalone" performance here would refer to the device's functional integrity as an implant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical performance tests was based on pre-established acceptance criteria derived from engineering specifications and the performance characteristics of the predicate devices. For the cadaveric evaluation, the ground truth was likely based on physician feedback and assessment of the device's functionality and implantability.
8. The Sample Size for the Training Set
There is no training set in the context of this device. This device is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 876.3630 Penile rigidity implant.
(a)
Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”