(224 days)
Erco-Vac™ is used to create an erection in men with erectile dysfunction. Erco-Vac™ can be used for patients with following conditions: Diabetes, Venous leakage, Prostatectomy, Hypertension, Psychogenic impotence, Impotence due to radiation therapy, Spinal cord injury.
Erco-Vac™ is based on the same scientific concept as known marketable vacuum constriction devices. Vacuum applied to penis causes blood inflow, engorgement and state of erection. Constriction device preliminary installed on the edge of vacuum chamber is forced to slip off on the root of the penis. By hindering blood outflow, constriction device sustains erection and makes intercourse possible. After releasing of vacuum and vacuum chamber removal, the user is ready to intercourse.
The provided text for the Erco-Vac™ primarily focuses on describing the device, its intended use, and claiming substantial equivalence to predicate devices for regulatory approval (510(k) submission). It does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on quantifiable performance metrics.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, and ground truth establishment cannot be extracted from the provided text. The document is a regulatory submission, not a clinical trial report.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., "device must achieve X level of rigidity in Y% of patients") nor does it report specific device performance against such criteria. It generally states "superior performance" compared to predicate devices due to technological differences, but this is not data-driven.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific test set, clinical trial, or patient data used to evaluate the device's performance.
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)
- Cannot be provided. Since there's no described test set or performance study, there's no mention of experts establishing a ground truth for such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set is 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
- Cannot be provided. This question is highly relevant to AI/imaging devices. The Erco-Vac™ is an external penile rigidity system, a mechanical medical device, not an AI or imaging device. Therefore, an MRMC study is not applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. As above, the device is a mechanical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No performance study with ground truth establishment is described.
8. The sample size for the training set
- Cannot be provided. The 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
- Cannot be provided. Not applicable due to the nature of the device.
Summary of what the document does provide:
- Intended Use: To create an erection in men with erectile dysfunction, applicable to various conditions like diabetes, venous leakage, prostatectomy, hypertension, psychogenic impotence, impotence due to radiation therapy, and spinal cord injury. (From Section 510(k) Summary and Indications for Use).
- Device Description: An external penile rigidity system (vacuum constriction device) that uses vacuum to draw blood into the penis, and a constriction device to retain the erection. (From Device Description section).
- Technological Improvements claimed:
- Transferable air-tight penile seal (adjusts to girth without inserts).
- Constriction device with controllable inward radial pressure (Erco-Ribbon™ allows user to prearrange pressure).
- Automatic vacuum release upon transfer of seal/constriction device.
- Transferring device for easy slip-off.
- Vacuum chamber with a domed closed end. (From Device Description section).
- Comparison to Predicate Devices: Claims "superior performance" due to the novel elements, addressing "deficiencies and drawbacks" of known marketable devices, such as the need for adapter inserts, lack of smooth control over inward pressure, and discomfort/bruises with predicate constriction rings. (From Device Description section).
- Regulatory Classification: Unclassified (78 LKY). (From 510(k) Summary).
- Substantial Equivalence: Claimed to Erercaid (K841257), VED (K901223), and Pos-T-Vac (K960828, K960342). (From 510(k) Summary and FDA letter).
The document is a regulatory submission for premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed clinical trial data with specific acceptance criteria and performance metrics.
§ 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.