(27 days)
The SJM® Tailor™ annuloplasty ring 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 ring is a flexible ring fabricated with a medical grade silicone rubber core, surrounded by polyester fabric. The full ring may be cut to form a partial or "C" ring.
The provided text is a 510(k) summary for the SJM® Tailor™ annuloplasty ring, model TARP. This document primarily focuses on establishing substantial equivalence to a predicate device (Tailor ring, model TARN) rather than presenting a standalone study with specific acceptance criteria and detailed device performance metrics in the way one might expect for a new AI/software device.
Therefore, the requested information, particularly regarding acceptance criteria and a study that proves the device meets those criteria (in terms of performance metrics like sensitivity, specificity, etc.), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, and training set sample sizes, is not present in the provided document.
The document is about a physical medical device (annuloplasty ring) and its substantial equivalence based on physical, non-clinical, and safety characteristics. It is not about a software or AI device that would typically have the kind of performance study details requested.
However, I can extract the information that is present regarding the comparison and testing:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide "acceptance criteria" in terms of performance metrics (like accuracy, sensitivity, etc.) or specific numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device based on characteristics and non-clinical testing.
| Characteristic | Equivalency Claim | Testing/Rationale |
|---|---|---|
| Product Labeling | Substantially Equivalent | Implied by submission for marketing based on predicate. |
| Intended Use | Identical | "repair of diseased or damaged mitral or tricuspid heart valves". |
| Physical Characteristics | Different (Holder and Handle only) | Non-Clinical Tests Performed: Holder to Handle connection, Holder assembly, Ring assembly to holder. (No specific numerical results reported in this summary). |
| Anatomical Sites | Identical | Mitral or tricuspid heart valves. |
| Target Population | Identical | Patients with diseased or damaged mitral or tricuspid heart valves determined to be repairable. |
| Performance Testing | Substantially Equivalent | Refers to predicate device (K000119) and testing for new holder/handle. (No specific numerical results reported in this summary). |
| Safety Characteristics | Substantially Equivalent | Non-Clinical Tests Performed: Microbiological Testing (Biocompatibility, Sterility Assurance), Manufacturing Process Validation. (No specific numerical results reported in this summary). |
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. The document describes non-clinical engineering and biological testing, not a clinical study on patient data with a "test set."
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. This is not a study requiring expert-established ground truth on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted (e.g., physical testing, microbiological testing), the "ground truth" would be established by standard engineering specifications, material properties, and biological testing protocols relevant to medical devices, not by expert consensus on clinical cases or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires 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.”