(206 days)
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.
The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is constructed of a titanium core with a silicone sewing ring margin covered with a polyester cloth.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Carpentier-Edwards® Physio Tricuspid™ annuloplasty ring, model 6200:
Summary of Acceptance Criteria and Device Performance for K103520
This 510(k) submission describes a medical device, an annuloplasty ring, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects (training set, test set, ground truth experts, MRMC studies, standalone performance) are not applicable in this context. The acceptance criteria here refer to the successful completion of design verification and validation testing for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional/Safety Testing | Computational stress analysis, Finite element analysis, Tensile strength, Suture retention, Flexibility, Ring / Ring holder removal force, Corrosion resistance, Magnetic resonance compatibility (RF heating, image artifact, displacement force, induced torque), Biocompatibility (percent inhibition of cell growth, medium eluate method - cytotoxicity, blood compatibility, complement activation, gene mutation assay, chromosomal aberration effect assay, agar overlay - cytotoxicity, DNA damage / effects assay, Mouse systemic injection - systemic toxicity, rabbit pyrogen - systemic toxicity, rabbit intracutaneous reactivity, guinea pig maximization, rabbit intramuscular implantation sub-chronic and chronic evaluations), Relative resistance evaluation and comparison for sterilization, Bioburden, Limulus amebocyte lysate pyrogen testing, Packaging qualification (visual inspection, sterile barrier integrity, dye leak, burst), Shelf-life assessments of packaging and product components, Design validation by surgeons in simulated use environment. | "The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, has successfully completed design verification and validation testing." (A general statement of success across all listed tests, without specific numerical results in this summary document.) The conclusion is that the device is "substantially equivalent to its predicate devices." |
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: This is a physical medical device, not an AI/ML system. There is no "test set" in the context of data for an algorithm. The testing involves physical prototypes or materials of the device. The provenance of the "data" would refer to where the biomechanical, material, and biocompatibility testing was performed. This information is not detailed in the summary, but such testing is typically done in controlled laboratory environments.
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 a physical medical device. There is no "ground truth for a test set" in the sense of expert annotation for an algorithm. However, the summary mentions "Design validation by surgeons in simulated use environment." While the number of surgeons and their specific qualifications are not provided in this summary, these would be the "experts" involved in validating the device's usability and surgical handling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As this is not an AI/ML system evaluating data, there is no "adjudication method" for a test set of data. The design validation by surgeons would likely involve observation, feedback, and potentially consensus or individual assessments of the device's performance in a simulated environment.
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 physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are irrelevant here.
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. Standalone performance refers to an AI system operating independently; this concept does not apply to a heart valve ring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI/ML sense): For a physical medical device, "ground truth" relates to established engineering standards, material science properties, biological compatibility guidelines, and successful clinical outcomes (which are implicitly aimed for). The successful completion of the listed functional/safety tests against established benchmarks and standards (e.g., ISO 10993 for biocompatibility, ASTM standards for MR compatibility) serves as the "ground truth" that the device meets its design requirements. Surgical design validation by experts also contributes to establishing usability "ground truth."
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not an AI/ML system. There is no concept of a "training set" for an annuloplasty ring. Device development involves iterative design, prototyping, and testing.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set or ground truth in the AI/ML sense. For a physical device, the "ground truth" for its development involves engineering principles, material specifications, regulatory standards, and clinical needs that guide its design and subsequent testing.
§ 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.”