(140 days)
The Mitra-Lift is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
Mitra-Lift Set is set of devices for mitral annuloplasty. This set consists of Mitra-Lift (implant device for mitral annuloplasty), and its accessories (Sizers and holders). The main device (Mitra-Lift series) is supplied sterile and intended for single use only. Mitra-Lift series is constructed of polyester textile materials and provided as the various sizes. It is intended to be used with its accessories, Mitral Sizer and Holder Handle.
The provided text is a 510(k) summary for the Mitra-Lift Set, an annuloplasty ring. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical outcomes or diagnostic performance. Therefore, many of the requested elements (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or contained within this type of regulatory submission.
However, I can extract the information that is present and indicate where information is not provided.
Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" here are implied by meeting the performance characteristics of the predicate device and relevant standards.
| Acceptance Criteria (Implied by equivalence and standards) | Reported Device Performance |
|---|---|
| Compliance with USP Monographs and EP Monographs for Absorbable surgical sutures | "Non-clinical laboratory testing was performed demonstration that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures." |
| Biocompatibility (non-toxic, non-hemolytic, non-pyrogenic) | "The results of biocompatibility testing support that the materials used in the manufacture of the Mitra-Lift are non-toxic, non-hemolytic, and non-pyrogenic. All testing was conducted under Good Laboratory Practices per 21 CFR Part 58." |
| Mechanical Integrity (specifically suture retention force) | "Mechanical Integrity testing for the COMVAR Set (including Mitra-Lift Set) includes suture retention testing which demonstrated that the design provided for a more than adequate retention force as compared to the predicate device." |
| Substantial Equivalence to predicate device (Simplici-T Annuloplasty System (K052970)) in design, materials, indications, intended use, packaging, and performance. | "Testing and other comparisons have established that the subject of Mitra-Lift Set is substantially equivalent in design, materials, indications and intended use, packaging, and performance to other predicate devices of the type currently marketed in the U.S. ... The Mitra-Lift has the same intended use and fundamental scientific technology as its predicate devices Simplici-T Annuloplasty System (K052970)..." |
Study Information (Based on Provided Text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of devices tested or experimental replicates for the mechanical integrity and biocompatibility tests.
- Data Provenance: The testing was non-clinical laboratory testing. No geographical origin of data or whether it was retrospective/prospective is applicable in the context of this non-clinical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission details non-clinical laboratory testing for substantial equivalence, not a clinical study involving expert interpretation or ground truth establishment for a diagnostic or imaging device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for studies involving human interpretation, which is not part of the described non-clinical testing.
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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. The Mitra-Lift Set is an annuloplasty ring (an implantable medical device), not a diagnostic or AI-powered system that would be subject to such a study design.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is an implantable device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Compliance with Good Laboratory Practices (GLP) per 21 CFR Part 58, ensuring materials are non-toxic, non-hemolytic, and non-pyrogenic. The "ground truth" is adherence to established biological safety standards.
- For Mechanical Integrity: Comparison against the performance of the predicate device and established engineering principles for "adequate retention force."
- For Monograph Compliance: Adherence to USP and EP Monograph specifications for surgical sutures.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device. "Training set" is not relevant.
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How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device. "Ground truth for training set" is not relevant.
§ 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.”