(60 days)
The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve Insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.
The Carpentier-Edwards Physio if Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole.
The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acqured or congental mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue.
For Type I mitral insufficiencies with no subvalvular lesions and normal vaivular movements, this ring technique used alone is sufficient However, the ring technique must be associated with mitral valvuloplasty repar in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III imitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy.
The Carpentier-Edwards Physio II annuloplasty ring, model 5200, is constructed of cobalt-chromium alloy/polyester film bands with a silicone sewing ring margin covered with a polyester cloth
The provided text is a 510(k) Summary for the Carpentier-Edwards Physio II™ Annuloplasty Ring, Model 5200. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results as one might find for a novel AI/medical imaging device.
Therefore, the specific information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data details, etc.) is not available in the provided text.
Based on the document, here's what can be inferred about the "acceptance criteria" and "study" in the context of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" in this context are implicitly that the Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, is comparable to its predicate device in design, intended use, materials, and principal of operation, and that it has successfully completed design verification testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Comparability in design, intended use, materials, and principal of operation to the predicate device (Carpentier-Edwards Physio™ Annuloplasty Ring, K926138) | "It has been demonstrated that the Carpentier-Edwards Physio II annuloplasty ring, model 5200, is comparable to its predicate device in design, intended use, materials, and principal of operation." |
| Successful completion of design verification testing | "The Carpentier-Edwards Physio II annuloplasty ring, model 5200, has successfully completed design verification testing." |
| Substantial equivalence to the predicate device | "The Carpentier-Edwards Physio II annuloplasty ring, model 5200, is substantially equivalent to its predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. "Design verification testing" typically involves various engineering tests, but the document does not specify the sample sizes of devices tested or the provenance of any data beyond a general statement of successful completion.
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)
This information is not applicable and not provided. This device is an annuloplasty ring, not an AI/diagnostic device that would involve expert interpretation for ground truth establishment in a clinical study. The "testing" referred to is likely engineering and bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a medical device like an annuloplasty ring, "ground truth" would be related to its physical properties, biocompatibility, mechanical performance, and clinical function. The document generally states "design verification testing" was successful, implying that physical and performance specifications were met. No specific "ground truth" establishment method like expert consensus or pathology for a test set is discussed, as this is not a diagnostic device.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/machine learning device.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a medical implant (annuloplasty ring). It relies on comparability to a predicate device and successful completion of design verification testing, rather than the types of clinical performance studies with acceptance criteria, expert involvement, and data sets typically associated with AI or diagnostic devices.
§ 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.”