(91 days)
MEMO 3D™ device is intended for correction of mitral insufficiencies or stenoinsufficiencies.
The use of the MEMO 3D™ device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized leaflets due to the fusion/hypertrophy of the chordae tendineae. the device implantation must be accompanied by corrective valvuloplasty.
The MEMO 3D™ Semirigid Annuloplasty Ring is supplied as a sterile, non- pyrogenic, non-ferromagnetic ring pre-mounted on a disposable holder. The annuloplasty ring is manufactured by embedding a metallic inner core with medical grade silicone. The resulting silicone sheath, around the metallic core, is then encased within a tubular knitted fabric coated with Carbofilm™, which is a thin layer of turbostratic carbon. The fabric is then sewn along its length with Carbofilm™ coated polyester thread.
The annuloplasty ring is attached to the disposable holder to maintain the shape of the ring during implantation and allow for measured plications of the mitral annulus. Suture guides are present on the holder to aid the surgeon during ring placement.
The MEMO 3D™ annuloplasty ring is available in sizes 24mm through 38mm in two millimeter increments. A complete set of accessory instrumentation is to be available separately to properly size the annulus and implant the annuloplasty ring.
The provided text is a 510(k) Summary for a medical device called the MEMO 3D™ Semirigid Annuloplasty Ring. It describes the device, its intended use, and indicates that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific details about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one would describe a clinical trial or performance study with quantified metrics for a device's diagnostic or predictive capabilities.
This document is a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices rather than proving de novo effectiveness through extensive clinical trials with acceptance criteria on specific outcomes, especially for mechanical devices like annuloplasty rings. The "performance testing" mentioned refers to non-clinical tests to ensure the device performs as expected and is comparable to existing devices, not a study to meet pre-defined acceptance criteria for, say, accuracy or sensitivity of a diagnostic algorithm.
Therefore, for the information requested, I will have to state that some points are "Not Applicable" or "Not Provided in the document" as the context of the document is a 510(k) summary for a mechanical annuloplasty ring, not an AI/algorithm-based diagnostic device.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as quantitative performance criteria in this 510(k) summary. The acceptance criteria for 510(k) equivalence are generally related to demonstrating similar safety and effectiveness through technological characteristics and non-clinical testing to predicate devices. | The MEMO 3D™ Semirigid Annuloplasty Ring demonstrated substantial equivalence to predicate devices for repair of the mitral valve through non-clinical testing. |
| Technological Characteristics: Substantial equivalence to predicate devices in: | Substantially equivalent to predicate devices in: |
| - Intended use | - Intended use |
| - Anatomical site for implantation | - Anatomical site for implantation |
| - Product labeling | - Product labeling |
| - Physical characteristics | - Physical characteristics |
| - Target population | - Target population |
| - Performance testing | - Performance testing (Non-clinical) |
| - Safety characteristics | - Safety characteristics |
| Non-Clinical Testing: Demonstrate equivalence through various tests. | Included: ultimate tensile strength, suture pull-out, rigidity determination, computational stress analysis, fatigue and durability testing, corrosion resistance, biocompatibility, sterilization validation, pyrogenicity, and shelf-life. |
2. Sample size 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 document. The document refers to "non-clinical testing" which implies bench testing rather than patient-based data. If there were a test set of patient data, its size and provenance are not mentioned.
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 or Not Provided in the document. For a mechanical device like an annuloplasty ring, "ground truth" in the context of expert review of test data (e.g., images for an AI device) is not typically established. The performance is assessed through engineering and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is Not Applicable or Not Provided in the document. Adjudication methods are typically relevant for human review of data, which is not described for the non-clinical testing of this device.
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. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data assisted by AI. This document pertains to a mechanical surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is Not Applicable. This device is a mechanical surgical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for AI/diagnostic devices (e.g., pathology as ground truth for cancer detection) is Not Applicable in this context. The "truth" for this device's performance relies on engineering standards, material science, and mechanical testing results demonstrating safety and equivalence to predicate devices. For biocompatibility, animal studies or in vitro tests might be used, often with histological examination or cell viability as endpoints, but these are not referred to as "ground truth" in the AI sense.
8. The sample size for the training set
This information is Not Applicable. The device is a mechanical implant; there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
This information is Not Applicable. Similar to point 8, there is no "training set" or corresponding "ground truth" establishment for this type of 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.”