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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.

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The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to:

Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes

mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.

Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant.

The device core consists of a malleable stainless-steel core, with titanium caps on both ends, and a PTFE (Polytetrafluoroethylene) tube cover. The entire outside surface of the cylinder is made out of silicone. The malleable stainlesssteel core enables the prosthesis to be moved into an erect position when desired and also enables the concealment of the prosthesis under clothing. All components consist of implantable, biocompatible materials.

The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity.

The prosthesis comes in two lengths. This includes 23 cm and 25 cm. The length is determined by the diameter of the prosthesis. Rigi10 Malleable Penile Prosthesis is available in five different diameter sizes; 9 mm, 10 mm, 11 mm, 12 mm, and 13 mm. Cylinders with 9 mm and 10 mm diameters are available in 23 cm length while cylinders with 11mm, 12 mm and 13 mm diameters are available in 25 cm length. There are four extenders (two pieces of 0.5 cm and two pieces of 1.0 cm) included in each product package. The extenders are accessories of the device and are available for adjusting the length of the prosthesis to match the total corporal measurement of the patient.

The document describes the acceptance criteria and the study conducted for the Rigi10 Malleable Penile Prosthesis.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the biocompatibility or bench performance tests. However, it indicates that the tests were conducted in accordance with recognized standards (ISO 10993-1 for biocompatibility and FDA guidance for penile rigidity implants for bench tests). The data provenance is laboratory testing conducted by Rigicon, Inc. or their designated testing facilities. It does not mention any human patient data for the purpose of primary device evaluation, as a clinical study was not conducted.

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

This information is not applicable as the studies described are bench (laboratory) and biocompatibility tests, not clinical studies involving human experts to establish ground truth on patient outcomes or diagnoses. The "ground truth" for these tests are the established specifications within the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set:

Not applicable. As described above, these were laboratory tests against established physical/chemical/biological specifications, not human expert adjudication of clinical findings.

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

Not applicable. The document describes a medical device (penile prosthesis), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth for the biocompatibility tests was established by the specifications and methodologies outlined in ISO 10993-1 "Biological evaluation of medical devices" guideline.

The ground truth for the bench performance tests was established by the specifications and methodologies outlined in the "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000, and the need to demonstrate "statistically significant substantial equivalence to the predicate device."

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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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

Study Information

1. 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.

2. 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.

3. Adjudication Method for the Test Set:

   • Not Applicable. As the evaluation was based on objective mechanical testing, there was no need for expert adjudication.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

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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

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.

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The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis.

All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a penile prosthesis and not an AI/ML device. Therefore, many standard AI/ML study components will not be present.

Device: Mentor Genesis™ Penile Prosthesis

Device Type: Penile Rigidity Implant (not an AI/ML device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the sample sizes (number of units/samples) used for each physical, mechanical, or biocompatibility test. It only states that "Physical and Mechanical testing" and "Biocompatibility testing" were conducted.
• Data Provenance: Not applicable in the context of this device. The testing describes lab-based performance verification, not data from human subjects or clinical populations.

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

• Not applicable. The "ground truth" here refers to the pre-defined engineering specifications and biocompatibility standards that the device had to meet. The determination of whether a test result "met all specifications" would typically be done by qualified testing personnel and reviewed by engineering/quality control teams, not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. Performance was assessed against pre-defined specifications for each test, not by adjudication of different evaluations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This is a physical medical device (penile prosthesis), not a diagnostic algorithm or AI system. Such studies are not relevant for this type of product.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Engineering Specifications and Biocompatibility Standards: The "ground truth" for this device's performance was established by internal engineering design specifications for physical and mechanical properties (e.g., specific thresholds for column strength, desired lubrication properties) and recognized international standards for biocompatibility (ISO 10993-5).

8. Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set was used.

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The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

Virilis Penile Prostheses

I am sorry, but the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study that proves the device meets acceptance criteria.

The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This process confirms that the new device is as safe and effective as a legally marketed device; it does not involve a study to demonstrate performance against specific acceptance criteria in the way a clinical trial or performance study would.

Therefore, I cannot provide the requested information based on the input text.

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