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Memo 3D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or stenoinsufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

The use of the MEMO 3D ReChord device is indicated for use in patients suffering from congenital or acquired mittal insufficiencies or steno-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 implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

The use of the Memo 4D device is indicated for use in patients suffering from congenital or acquired mitral insufficiencies or steno-insufficient with dilatation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation' breakage of the chordae tendineae and payillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.

Like their predicate devices, the subject MEMO 3D, MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings are supplied as sterile, nonpyrogenic ring pre-mounted on disposable holders.

Both the predicate and subject devices are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.

The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread.

Both the predicate and subject devices MEMO 3D ReChord and MEMO 4D Semirigid Annuloplasty Rings feature a fully removable system (i.e., the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread.

The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.

The MEMO 3D and MEMO 3D ReChord Annuloplasty Rings are manufactured in 8 different sizes, from 24 to 38 mm, with 2 mm increments.

The MEMO 4D Annuloplasty Ring is manufactured in 10 different sizes, from 24 to 42 mm, with 2 mm increments.

A complete set of accessories is available separately to properly size the annulus and implant the MEMO 3D, MEMO 3D ReChord and MEMO 4D annuloplasty ring.

The provided document is a 510(k) summary for the Memo 3D Semirigid Annuloplasty Ring, Memo 3D ReChord Semirigid Annuloplasty Ring, and Memo 4D Semirigid Annuloplasty Ring. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the way a clinical study report would.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on showing that changes in raw materials and manufacturing (alternative suppliers for PET fabric and suture thread, and a different sewing path) do not alter the fundamental characteristics or performance compared to the predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable in the context of a 510(k) submission primarily relying on non-clinical testing for material and manufacturing changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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 device is an annuloplasty ring, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Data Provided (Section VII):

The submission relies on the following non-clinical performance data to demonstrate substantial equivalence:

• Biocompatibility testing
• Mechanical characterization of the PET fabric from the alternative supplier.
• Mechanical characterization of the PET suture thread from the alternative supplier and the alternative sewing path.
• Mechanical testing of the final device manufactured with the new suppliers' materials and sewing path.
• Quality control testing to evaluate the Carbofilm™ coating on the PET fabric and suture thread from the alternative suppliers.
• LAL test to evaluate endotoxin contamination on the new materials and final devices.

Clinical Performance Data (Section VIII):

The document explicitly states: "No clinical testing was conducted in support of the subject devices, as the indications for use are equivalent to those of their predicate devices (K071327, K142221, K180411). The non-clinical testing referred to in this submission supports the substantial equivalence of these devices."

Therefore, the approval is based on the substantial equivalence of the modified devices to already cleared predicate devices, supported by non-clinical testing to ensure that the changes in raw materials and manufacturing methods do not adversely affect the safety and effectiveness of the device.

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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

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.

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