(84 days)
The Male Remeex System is intended to be used as a pubourethral sling for the treatment of male stress urinary incontinence
The MALE REMEEX SYSTEM (EXternal MEchanical REqulation) is included in the sling techniques for the treatment of urinary incontinence. This system is comprised of a pubourethral sling that permits the patient continence level regulation. This system use a sling, placed under the urethra that can be regulated at any time to get the most adequate bladder neck angle for a particular patient. The sling is connected by traction threads to the prosthesis. The prosthesis is situated over the fascia of the abdominal rectus muscle and is a mechanism that permits the regulation of the sling level.
The provided text does not contain information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical measures. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
However, based on the provided text, here’s an attempt to extract relevant information and note what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance for Intended Use | Not explicitly stated in terms of specific thresholds (e.g., success rate, continence improvement). | "Results of in vitro and clinical evaluations were used to show that the Male Remeex System functioned as clinically intended." |
| "Sufficient data has been gathered from testing to assess that the Remeex System performs as intended." | ||
| Safety | Not explicitly stated in terms of specific adverse event rates or complication rates. | Implied by "Any differences between the two devices do not raise new questions of safety and effectiveness." |
| Technological Equivalence | To be "the same" as the predicate device. | "Technologically, both the new device and the predicate device are the same (i.e. both are meshes that provide pubourethral support) and are indicated for the treatment of urinary incontinence." |
Missing Information Regarding Acceptance Criteria and Performance:
- No quantitative acceptance criteria are defined for clinical outcomes (e.g., success rate, reduction in leakage, quality of life improvement).
- No specific performance metrics are reported from the clinical evaluations. The statements are general affirmations of function.
Study Details:
The provided document highlights that "Results of in vitro and clinical evaluations were used to show that the Male Remeex System functioned as clinically intended." However, it does not provide granular details about these studies. Therefore, much of the requested information is not available in the given text.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only mentions "clinical evaluations."
3. Number of Experts and Qualifications for Ground Truth:
- Not specified. The document does not detail how the results of the "clinical evaluations" were formally assessed or how ground truth for clinical intended function was established by experts.
4. Adjudication Method:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (comparing human readers with and without AI assistance) is not applicable to this medical device, which is a physical surgical implant (a pubourethral sling), not an AI diagnostic or image analysis tool.
6. Standalone (Algorithm Only) Performance Study:
- No. This is not an AI algorithm but a physical medical device.
7. Type of Ground Truth Used:
- Implicitly, the "clinical evaluations" would have relied on clinical outcomes data related to urinary continence, subjective patient reports, and potentially objective measures associated with the sling's function. However, the specific methodology for establishing "ground truth" (e.g., through physical examination by urologists, patient diaries, objective stress tests) is not detailed.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.