(26 days)
The Classic and Esteem vacuum systems are intended to artificially produce an erection in males suffering from erectile dysfunction (impotence) in order to facilitate sexual intercourse. A vacuum is applied to the penis, causing it to become erect and rigid as blood is drawn into the corpora cavernosa. A constriction ring is then placed on the base of the penis to restrict venous blood flow out of the penis. The device is intended to be used at home or in a doctor's office or clinic.
The silicone Freedom Ring™ was developed as an alternative constriction ring for the ErecAid Classic and Esteem vacuum erection devices. It is similar to the existing polyisoprene Pressure-Point™ Ring (PPR) in that it contains both a urethral notch and dorsal pressure points. It is designed to deliver the same sealing pressure to the penis, thus preventing escape of blood after an erection is achieved. The Freedom Ring makes the vacuum seal against the base of the penis rather than against the groin, thereby reducing the probability of scrotal tissue or pubic hair entrapment.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ErecAid® Classic and Esteem vacuum erection systems with the new Freedom Ring:
The provided document (K020082) describes a modification to an existing device, a vacuum erection system, specifically the introduction of a new constriction ring called the "Freedom Ring." The core of the submission revolves around demonstrating that this new ring does not introduce new safety or efficacy issues compared to the previously accepted "Pressure-Point Ring" (PPR).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| Physical Properties and Dimensions: The physical properties and dimensions of the new Freedom Ring™ must be comparable to those of the corresponding sizes of the existing Pressure-Point™ Ring (PPR). | Met: "Physical properties and dimensions of the new Freedom Ring were compared to those of the corresponding sizes of Pressure-Point Ring." (Implies comparability, as it's not stated that they fail to be comparable.) |
| Pressure Exerted on the Penis: The pressure exerted on the penis by each Freedom Ring must be comparable to that of the corresponding size PPR. | Met: "The pressure exerted on the penis by each Freedom Ring was verified to be comparable to that of the corresponding size PPR." |
| Initial Vacuum Seal: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding initial vacuum seal. | Met: "bench testing was conducted to demonstrate that the Classic and Esteem systems continued to meet documented product specifications regarding initial vacuum seal..." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for vacuum seal performance). |
| Maximum Vacuum Pressure: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding maximum vacuum pressure. | Met: "...continued to meet documented product specifications regarding... maximum vacuum pressure..." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for maximum vacuum pressure). |
| Leak Rate: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding leak rate. | Met: "...continued to meet documented product specifications regarding... and leak rate." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for leak rate). |
| Clinical Equivalence (Implicit): The new Freedom Ring™ must introduce no new issues of safety or efficacy compared to the predicate device. | Met (Claimed by Manufacturer): "Timm Medical Technologies, Inc. believes that the new Freedom constriction ring introduces no new issues of safety or efficacy with respect to the ErecAid Classic and Esteem vacuum erection systems." (This is a summary conclusion based on the bench testing and the design's intent to improve comfort without affecting the core function.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" of the Freedom Ring and the vacuum systems. Given the nature of physical property and pressure measurements, it likely involved a sample of manufactured rings and representative vacuum devices.
- Data Provenance: The data originates from bench testing conducted by Timm Medical Technologies, Inc. This is a prospective evaluation of the newly designed Freedom Ring. The country of origin is not explicitly stated but can be inferred as the USA, where the manufacturer is located (Eden Prairie, MN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For bench testing of physical properties and mechanical performance, "ground truth" is established by measurement against predefined engineering specifications and comparisons to known performance characteristics of the predicate device (PPR). This typically involves engineers, quality control personnel, and technicians rather than medical experts for establishing ground truth for device performance in this context. While the design was for patient comfort, the testing was against objective benchmarks.
- Qualifications of Experts: Not explicitly stated, as no "experts" in the medical sense were used to establish ground truth for this type of testing. The work would have been performed by qualified technical staff.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based evaluations where there is subjective interpretation or diagnostic uncertainty requiring consensus among human readers. For the bench testing described, the measurements are objective, and the results are compared directly to engineering specifications or the predicate device's measured performance. Discrepancies would be resolved through re-testing or analysis of measurement methodologies rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was required to demonstrate safety or effectiveness of the new Freedom constriction ring when used with either the ErecAid Classic or Esteem vacuum erection system."
- Effect Size: Not applicable. Since no MRMC study was conducted, there is no reported effect size regarding human readers' improvement with or without AI assistance. (It's important to note this device is not an AI-based diagnostic tool, so such a study would not be relevant in this context anyway.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a mechanical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance testing is not relevant or performed.
7. The Type of Ground Truth Used
- The ground truth for the bench testing was based on objective engineering and manufacturing specifications for the vacuum devices themselves (initial vacuum seal, maximum vacuum pressure, leak rate) and comparative physical/mechanical properties against the predicate "Pressure-Point Ring" (PPR) for the new Freedom Ring (dimensions, physical properties, and pressure exerted on the penis).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm. There is no "training set."
9. 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.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.