(59 days)
The SJM® Tailor™ annuloplasty band is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital processes.
The Tailor band is a flexible band fabricated with a medical grade silicone rubber core, surrounded by polyester fabric.
The provided document is a 510(k) summary for a medical device, the SJM® Tailor™ annuloplasty band. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to establish acceptance criteria and performance. Therefore, most of the requested information regarding acceptance criteria, study details, and human-AI comparative effectiveness is not applicable to this document.
Here's a breakdown of the parts that can be addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device through various non-clinical tests.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Product Labeling | Substantially Equivalent to predicate | Substantially Equivalent |
| Intended Use | Identical to predicate | Identical |
| Physical Characteristics | Substantially Equivalent to predicate | Substantially Equivalent |
| Anatomical Sites | Identical to predicate | Identical |
| Target Population | Identical to predicate | Identical |
| Performance Testing | Identical to predicate | Identical |
| Safety Characteristics | Identical to predicate | Identical |
| Band end evaluation | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Gapping | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Band release | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Suture Retention | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Suture pull | Demonstrated satisfactory performance in comparison to predicate | Performed |
| Biocompatibility evaluation | Demonstrated satisfactory performance | Performed |
| Sterility Assurance evaluation | Demonstrated satisfactory performance | Performed |
| Manufacturing Process Validation | Demonstrated satisfactory performance | Performed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a patient-based test set in the context of AI or diagnostic performance. The tests mentioned are for material and mechanical properties, not clinical assessment on patients.
- Data provenance: Not applicable. The tests performed are laboratory-based and do not involve patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment by experts in the context of image interpretation or diagnosis for this device's non-clinical testing. The tests are physical and microbiological validations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "adjudication method" in the context of clinical interpretation or expert review for this type of non-clinical testing.
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. This is a medical device for heart valve repair (an annuloplasty band), not an AI diagnostic or assistance tool that would undergo MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material integrity, mechanical strength, and biocompatibility, as well as validated testing methods. It's not a clinical "ground truth" derived from patient-specific data.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”