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510(k) Data Aggregation
(29 days)
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
PROseries™ Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
PROseries Bioimplants are not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
The provided text is a 510(k) summary for a medical device (PROseries Bioimplants) and it explicitly states that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than presenting a de novo study with acceptance criteria and a detailed study proving those criteria were met in the way a clinical trial for a novel drug or a new AI diagnostic would.
Therefore, many of the requested sections (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission and information is not available in the provided document.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance
For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons across various attributes. Specific quantitative acceptance criteria for performance as in a clinical trial are generally not provided in this type of summary.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Design: Identical to predicate device | PROseries Bioimplants are identical to the predicate device in terms of design. |
| Technology: Identical to predicate device | PROseries Bioimplants are identical to the predicate device in terms of technology. |
| Intended Use: Identical to predicate device | PROseries Bioimplants are identical to the predicate device in terms of intended use. (See "Statement of Intended Use" for details). |
| Materials: Identical to predicate device | PROseries Bioimplants are identical to the predicate device in terms of materials. (Comprised of collagen matrix from equine pericardial tissue reinforced by a woven polymer). |
| Performance: Identical to predicate device | Biocompatibility testing, biomechanical bench testing, and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics, demonstrating identity to predicate. |
| Processing Methods: Identical to predicate device | PROseries Bioimplants are identical to the predicate device in terms of processing methods. |
| Sterility: Meets USP sterility testing and FDA LAL endotoxin limits | The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. |
2. Sample size 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 information is typically relevant for studies designed to establish de novo safety and effectiveness, or for AI/diagnostic devices that require large datasets for validation. For a substantial equivalence claim based on physical device characteristics, this detailed information about "test sets" or "data provenance" in the context of clinical data is not expected in this summary. The "testing" referred to is laboratory and in vivo performance testing.
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. No ground truth established by experts in this manner is described as part of this submission, as it's not an AI or diagnostic device requiring such evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not provided. Not relevant for this type of device and submission.
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
- Not Applicable / Not provided. This is a physical surgical mesh, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not provided. This is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not provided. The "truth" for this device revolves around its physical, chemical, and biological properties (biocompatibility, biomechanical strength, sterility) matching the predicate device and meeting relevant standards. It's not about diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
- Not Applicable / Not provided. This device is not an AI model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not provided. As there is no training set, this question is not applicable.
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