(48 days)
The NeoForm™ Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.
The NeoForm™ Annuloplasty Ring, Model 4200 is a rigid implantable annuloplasty ring designed to reduce and stabilize the valve annulus in patients undergoing mitral repair. The inner core of the ring is made of a titanium alloy. Silicone covers the inner core and a sewing cuff made of polyester fabric encompasses the ring. Three points of the ring are marked with polyester suture to aid in suture placement for implantation. The ring is available in four sizes: 26 mm; 28 mm; 30 mm; and 32 mm.
This document describes the 510(k) summary for the NeoForm™ Annuloplasty Ring, Model 4200. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance metrics against specific acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested points, such as specific acceptance criteria related to AI performance, sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this type of medical device submission.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria for the performance of the annuloplasty ring in a numerical or statistical sense as one would expect for an AI algorithm. Instead, the "acceptance " is based on demonstrating substantial equivalence to a predicate device through functional and safety testing. The reported "performance" is that the device met these requirements and is equivalent to the predicate.
| Acceptance Criteria Category | Reported Device Performance and Equivalence |
|---|---|
| Functional and Performance Requirements | Device design meets functional and performance requirements. Data demonstrates equivalence to the predicate and/or reference device. |
| Technological Characteristics | Same technological characteristics as the predicate device (GeoForm™ Annuloplasty Ring, Model 4200 (K032250)). |
| Intended Use | Equivalent to the predicate device. |
| Indications for Use | Equivalent to the predicate device. |
| Principles of Operation | Equivalent to the predicate device. |
| Fundamental Technology | Equivalent to the predicate device. |
| Materials of Composition | Similar or identical to the predicate device. |
| Size Range | Similar or identical to the predicate device. |
| Sizing Accessories | Similar or identical to the predicate device. |
| Site of Application in the Body | Similar or identical to the predicate device. |
| Biocompatibility | Tested to support substantial equivalence. |
| Sterilization | Tested to support substantial equivalence. (Minor modification from predicate). |
| Computational Finite Element Analysis (FEA) | Performed to support substantial equivalence. |
| Tensile strength of ring materials | Tested to support substantial equivalence. |
| Suture pull-out testing | Tested to support substantial equivalence. |
| MRI Compatibility | Tested to support substantial equivalence. |
| Packaging | Tested to support substantial equivalence. (Minor modification from predicate). |
| Shelf-life | Tested to support substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document states "representative samples of the devices underwent testing" for functional and safety tests. Specific sample sizes for each test are not provided.
- Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is not an AI/algorithm-based device and does not involve establishing ground truth from expert readings in that context. The "truth" for the device's functional and safety performance is based on engineering and materials science standards and testing.
4. Adjudication method for the test set
This is not applicable as there is no expert reading or interpretation requiring adjudication in the context of an AI/algorithm.
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 is not applicable. This device is an annuloplasty ring, not an AI-assisted diagnostic or treatment tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this medical device is established by:
- Engineering specifications and design requirements: The device's physical properties, materials, and mechanical behavior.
- Performance against established standards: Biocompatibility standards, sterilization efficacy, material strength standards, etc.
- Comparison to a legally marketed predicate device: Demonstrating that the new device performs similarly or equivalently to a device already deemed safe and effective.
8. The sample size for the training set
This is not applicable as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/algorithm-based device.
§ 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.”