Search Results

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.

Ask a specific question about this device

MEMO 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies.

The use of the Memo 4D device is indicated for correction of congenital 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 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.

Like its predicate device (the MEMO 3D ReChord Semirigid Annuloplasty Ring, K142221), the MEMO 4D Semirigid Annuloplasty Ring is supplied as a sterile, non-pyrogenic ring pre-mounted on a disposable holder.

Both the predicate and subject device 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 device 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 following changes were implemented:

The MEMO 4D is available in two new sizes: 40mm and 42mm.

The MEMO 4D features a larger silicone filler layer in the outer portion of the ring, intended to further facilitate ring suturing to the annulus.

A re-shaping of the MEMO 4D annuloplasty ring was implemented for sizes 34 to 42 mm. These sizes maintain the same core cross-sectional diameter and commissure-to-commissure dimension as the predicate MEMO 3D ReChord, but feature a gradual increase of the ring antero-posterior dimension and an out-of-plane "saddle" shape in the anterior ring portion. The ring re-shaping creates a differentiated design for the MEMO 4D with respect to the MEMO 3D ReChord. The design includes a rounder shaped implant to accommodate cases of excess leaflet tissue which may be indicative of degenerative mitral disease.

Minor design changes to the disposable holder to adapt to the modified ring shape and a new injection molding supplier for the holder were also introduced. The MEMO 4D packaging system was redesigned, introducing a double nested blister to replace the polysulfone containers used for the predicate MEMO 3D ReChord.

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

The provided text is a 510(k) Summary for the MEMO 4D Semirigid Annuloplasty Ring, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already on the market. In this context, "acceptance criteria" and "device performance" don't refer to typical clinical performance metrics for a diagnostic AI device, but rather to the engineering and design characteristics that demonstrate equivalence to the predicate device and ensure safety and efficacy.

Therefore, the requested information elements (1-9) need to be interpreted in the context of a medical device submission based on substantial equivalence, rather than a study validating an AI diagnostic algorithm.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "device performance" results in the manner one might expect for a diagnostic AI study. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the MEMO 4D device maintains the safety and effectiveness profile of its predicate device, the MEMO 3D ReChord Semirigid Annuloplasty Ring (K142221).

The "acceptance criteria" are implied to be that the MEMO 4D performs comparably to the predicate or meets established engineering standards for such devices. The "reported device performance" is the successful completion of the non-clinical tests, indicating that the design changes did not negatively impact safety or efficacy.

Previous testing on the predicate device for suture pull-out, corrosion resistance, and long-term biocompatibility remains valid for MEMO 4D due to similar materials, design, and manufacturing technologies.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set sample size" in terms of clinical cases or patient data, as this was a non-clinical submission. The "test set" refers to the physical devices and materials used in the various non-clinical engineering and biological tests (e.g., computational models for FEA, physical rings for tensile strength, fatigue, and extraction tests, materials for biocompatibility, etc.).

• Sample Size: Not explicitly stated for each test, but typically, these tests involve a sufficient number of samples as per recognized engineering standards (e.g., ISO, ASTM) to provide statistical confidence.
• Data Provenance: The testing was conducted by Sorin Group Italia S.r.l. and appears to be internal validation data. The country of origin for the testing would be Italy, where Sorin Group Italia S.r.l. is located. The nature of the data is retrospective in the sense that it's laboratory-generated data for product validation, not prospective clinical trial data.

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 there was no clinical "test set" requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical performance relies on established engineering principles, materials science, and regulatory standards. The experts involved would be engineers, material scientists, and regulatory specialists within Sorin Group Italia S.r.l., along with those at the FDA reviewing the submission. Their qualifications are inherent in their professional roles, but not detailed here.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic accuracy, where multiple readers interpret cases and a consensus is reached. The performance data presented here is from non-clinical engineering and material property tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was conducted in support of the MEMO 4D Semirigid Annuloplasty Ring, as the indications for use are equivalent to those of its predicate device MEMO 3D ReChord." Therefore, there is no effect size for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to a physical medical device like an annuloplasty ring. This question is relevant for AI algorithms. The MEMO 4D is an implantable device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Standards and Specifications: For mechanical properties, durability, material compatibility, and packaging integrity.
• Biocompatibility Standards: In vitro and potentially in vivo (from predicate) tests to ensure the materials are safe for implantation.
• Regulatory Precedent: The predicate device (MEMO 3D ReChord) having a proven safety and efficacy record on the market established the "ground truth" for the device type, allowing for substantial equivalence without new clinical data.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI algorithm or a machine learning model for this medical device submission. The device is a physical product designed and manufactured based on established engineering principles, not trained on data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for an AI algorithm. The device's design and manufacturing rely on established medical device development processes and regulatory compliance rather than machine learning "ground truth" establishment.

Ask a specific question about this device