(103 days)
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are indicated for use in patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings and bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
The FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band are fully flexible annular rings and bands designed to reduce and stabilize the valve annulus in patients undergoing mitral or tricuspid repair.
The rings and bands are made of braided polyester fabric. The ring and band contain a circumferential flexible radiopaque marker. The internal radiopaque marker provides radiographic visualization along the entire circumference.
The rings and bands are available in nine sizes: 24 mm; 26 mm; 28 mm; 30 mm; 32 mm; 34 mm, 36 mm, 38 mm and 40 mm. The size refers to the inner circumference between the green suture markers nearest the anterior location of the ring and band. FlexForm™ Sizers, Model FRBS, are used to determine the correct size of the ring or band.
The differences between the ring and band are as follows: The FlexForm™ Ring is a complete annular ring. Five markers are provided on the ring; two markers indicate the approximate location of the trigones; three additional markers are provided as an aid to suture placement in the posterior section.
The FlexForm™ Band is a partial ring, without an anterior segment. The key dimensions are the same as the FlexForm Annuloplasty Ring, except for the absence of the anterior segment. Five markers are provided on the band; two markers indicate the approximate location of the trigones; three markers are provided as an aid to suture placement in the posterior section.
The choice of ring or band is based on surgeon preference.
The provided text is a 510(k) summary for a medical device (FlexForm™ Annuloplasty Ring and FlexForm™ Annuloplasty Band). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not typically found in a 510(k) summary like this one.
510(k) submissions primarily focus on:
- Comparison to a Predicate Device: Demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to an already cleared device.
- Non-Clinical Testing: Typically involves bench testing (e.g., tensile strength, fatigue, sterilization validation, biocompatibility) to show the device meets engineering specifications and standards, but not direct clinical outcomes or diagnostic performance.
Based on the provided text, here's what can be extracted, and what cannot be:
Information Available:
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1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The device passed various performance tests to ensure it meets functional and performance requirements. The specific numerical acceptance criteria are not provided.
- Reported Device Performance (as listed in "Non-Clinical Tests"):
- Tensile strength of ring body materials
- Tensile strength of construction sutures
- Suture pull-out testing
- (NOTE: The actual numerical results of these tests and how they compare to specific acceptance criteria are not included in this summary.)
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This device is a physical annuloplasty ring/band, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device underwent "Functional and Safety Testing" which are non-clinical hardware tests.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests (tensile strength, suture pull-out), the "ground truth" would be the engineering specifications and established test methodologies for material properties. This is implicitly linked to industry standards and regulatory guidance for medical devices, rather than expert consensus on clinical data or pathology. Specific details are not provided.
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8. The sample size for the training set:
- N/A: This is a physical medical device, not an AI algorithm that requires a training set. The "samples" referred to are representative physical samples of the manufactured device used for non-clinical testing.
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9. How the ground truth for the training set was established:
- N/A: Not applicable for a physical device.
Information NOT Available in this Document:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "representative samples" for testing, but does not specify the number of samples for each test, nor the "data provenance" as this refers to clinical data, which was not used for this type of submission.
- 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)
- N/A: No clinical study involving expert ground truth for a test set is described here. The "ground truth" for the non-clinical tests would be the predetermined engineering specifications, not expert clinical consensus.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No clinical study or expert review of a test set is described.
- 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
- N/A: This is a physical device, not an AI diagnostic tool, so MRMC studies and "human readers" improving with AI are not relevant.
In summary, as this is a 510(k) summary for a physical medical device, it relies on demonstrating substantial equivalence through non-clinical performance and material characterization, rather than clinical studies with human "readers" or algorithms that would involve the extensive details requested in your prompt.
§ 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.”