(111 days)
The Tactra™ device is designed to provide penile rigidity and the device can be placed in either an erect or a concealed position.
The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation.
All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized.
This document appears to be a 510(k) Pre-market Notification for a medical device (Tactra™ Penile Prosthesis), not a study report detailing acceptance criteria and performance of a device based on clinical data or AI algorithm performance.
Therefore, many of the requested items related to "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. Specifically, there is no information regarding:
- A table of acceptance criteria and reported device performance (in the context of clinical benchmarks or AI algorithm metrics).
- Sample sizes for test sets, data provenance, or details about training sets.
- Number/qualifications of experts, adjudication methods, or ground truth establishment for a study related to acceptance criteria.
- MRMC comparative effectiveness studies or standalone algorithm performance.
This document describes the device, its intended use, and its substantial equivalence to predicate devices based on bench testing and biocompatibility testing. It explicitly states: "The Tactra Penile Prosthesis incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices... To demonstrate substantial equivalence... technological characteristics and performance criteria were evaluated using bench testing, and biocompatibility testing. The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices."
As such, I cannot provide the requested information that typically comes from a performance study or clinical trial report.
However, I can extract the following relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied by Substantial Equivalence): The device's technological characteristics and performance (as evaluated by bench and biocompatibility testing) must not raise new questions of safety and effectiveness compared to the predicate devices (AMS Spectra™ Concealable Penile Prosthesis and Mentor (Coloplast) Genesis™).
- Reported Device Performance: "The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided: This document describes bench and biocompatibility testing, not human clinical trials or AI algorithm testing with specific test sets in the traditional sense. Therefore, there are no details on sample size, data provenance, or study design types (e.g., retrospective/prospective).
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)
- Not applicable/Not provided: Ground truth establishment by experts is relevant for studies involving subjective human interpretation (e.g., medical imaging AI). This document details device engineering and material science testing, not interpretative tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided: Not relevant for the type of testing described.
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
- No: This device is a penile prosthesis, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the context of an AI study: The "truth" or reference standard for bench and biocompatibility testing would be established industry standards, specifications, and regulatory requirements for material properties, mechanical performance (e.g., rigidity, malleability, durability), and biological response. No details on specific "ground truth" establishment methods are provided beyond "bench testing, and biocompatibility testing."
8. The sample size for the training set
- Not applicable/Not provided: No training set mentioned as this is not an AI/machine learning submission.
9. How the ground truth for the training set was established
- Not applicable/Not provided: No training set or associated ground truth discussed.
§ 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.”