(93 days)
The Remeex System is intended to be used as a pubourethral sling for treatment of female stress urinary incontinence (SUI) resulting from urethral hypomobility or hypermobility and / or intrinsic sphincter deficiency.
The REMEEX SYSTEM (EXternal MEchanical REgulation) 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 K033310 ("Specialities Remeex International, s.l. Remeex System") is a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a full clinical trial.
Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.
Here's why and what information can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document explicitly states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, it does not provide quantifiable acceptance criteria or a table comparing performance against such criteria. The basis for clearance is substantial equivalence to the predicate device (Ethicon/Gynecare Pubourethral Sling, K974098), implying that if the device performs comparably to the predicate, it is considered safe and effective for its intended use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document mentions "clinical evaluations" and "clinical testing" but does not specify the sample size, design of the study (retrospective or prospective), or the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. In a 510(k) submission based on substantial equivalence, the concept of "ground truth" established by experts for a test set, in the way it's used for AI/diagnostic device validation, is generally not present. The assessment is usually through clinical outcomes in a comparative study or by demonstrating similar performance to the predicate device.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. Since there's no mention of a diagnostic performance study requiring ground truth establishment, adjudication methods are not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- Not explicitly defined in the context of typical AI/diagnostic device validation. For a surgical device like this, "ground truth" would generally refer to observed clinical outcomes (e.g., resolution of stress urinary incontinence, complication rates) in a clinical evaluation, compared to the predicate device or a recognized standard of care. The document states "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended," implying clinical outcomes were assessed, but the specifics are not detailed.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. As there is no AI algorithm or training set, this information is not relevant.
Summary based on the document:
The 510(k) submission for the Remeex System relies on demonstrating substantial equivalence to a predicate device (Ethicon/Gynecare Pubourethral Sling, K974098). The claim of substantial equivalence is supported by:
- Technological Characteristics: Both the new device and the predicate device are described as "meshes that provide pubourethral support" and utilize accessories for surgical procedures, with no differences raising new questions of safety and effectiveness.
- Performance Data: The document states that "Results of in vitro and clinical evaluations were used to show that the Remeex System functioned as clinically intended" and "Sufficient data has been gathered from clinical testing to assess that the Remeex System performs as clinically intended." However, specific quantitative data, sample sizes, or detailed methodology for these evaluations are not included in the provided excerpts.
The document does not provide the detailed information requested in your prompt regarding acceptance criteria tables, specific sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are typically required for different types of device submissions (e.g., new technology requiring de novo classification or devices with AI components).
§ 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.