(28 days)
The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, 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 and metal 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AMS Spectra™ Concealable Penile Prosthesis:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cycle Life | Met Acceptance Criteria |
| Springback Angle | Met Acceptance Criteria |
| Column Strength (Rigidity) | Met Acceptance Criteria |
| Bend Force | Met Acceptance Criteria |
| Packaging | Met Acceptance Criteria |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: Not explicitly stated as a number of devices. The document refers to "mechanical performance tests" on "the Spectra™ product" and "the Spectra™ device." It implies an adequate number of devices were tested to establish meeting the criteria for each test type.
- Data Provenance: The studies were nonclinical performance tests conducted by the manufacturer, American Medical Systems Inc. (AMS). The country of origin for the data is not specified but is implicitly the United States, given the submission to the FDA. The tests are prospective in nature as they were conducted to evaluate the new device.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This device is a medical device (penile prosthesis) and the evaluation relied on mechanical performance tests, not human interpretation of data for diagnostic purposes. Therefore, there was no "ground truth" derived from expert consensus for the test set. The ground truth was the objective measurement against pre-established acceptance criteria for mechanical properties.
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Adjudication Method for the Test Set:
- Not Applicable. As the evaluation was based on objective mechanical testing, there was no need for expert adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. The document explicitly states: "Because the intended use and technological characteristics of the predicate Spectra™ and DURA II® devices were maintained in the subject AMS Spectra™, a clinical study was not conducted for the subject Spectra™ device." MRMC studies are typically used to assess the impact of a new diagnostic aid on human reader performance, which is not relevant for this type of medical device submission.
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Standalone (Algorithm Only) Performance Study:
- Yes, in the sense of the device's mechanical performance. The nonclinical performance tests assessed the device's performance in isolation, without human interaction beyond operating the testing equipment. This represents the "standalone" performance of the physical device.
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Type of Ground Truth Used:
- Objective Mechanical Measurements and Specifications. The "ground truth" for the performance tests was defined by the pre-established "acceptance criteria" for each mechanical test (cycle life, springback angle, column strength, bend force, and packaging).
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Sample Size for the Training Set:
- Not Applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes for the device would be informed by engineering principles and prior device experience, but not through a formal "training set" of data.
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How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this submission. The "ground truth" for the device's design and engineering would be based on established engineering standards, material science, and performance requirements for penile prostheses, likely derived from extensive industry experience with similar devices.
§ 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.”