(34 days)
The ATS SIMULUS FC Annuloplasty Bands are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.
The ATS SIMULUS FC Annuloplasty Bands are implantable, fully flexible, annular bands (Figure 1). The bands reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the band is made of braided Polyester. The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque.
The annuloplasty bands and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle.
The bands are available in the following sizes: 23 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the band. Green trigone markers are spaced at 120° from the midpoint of the posterior segment, which is also indicated by a green marker.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ATS SIMULUS FC Annuloplasty Band:
The document (K052899) is a 510(k) premarket notification for a medical device. In this type of submission, the primary goal is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving stand-alone effectiveness or a specific clinical benefit beyond what the predicate offers. Therefore, the information provided focuses on comparative aspects and safety/performance characteristics relevant to the predicate.
Based on the provided text, there is no clinical study presented that demonstrates the device meets specific performance acceptance criteria in the way you've outlined for an AI/device performance study.
Instead, the submission relies on:
- Equivalence to a predicate device: The ATS SIMULUS FC Annuloplasty Band is deemed equivalent to the K905175, PTI Annuloplasty Ring (now Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring) based on design, material composition, surgical technique, and intended use. This is the core "proof" of acceptability for a 510(k) submission.
- Non-clinical testing: Safety and fundamental performance are addressed through laboratory and bench tests.
Here's a breakdown of the requested information, indicating where the document provides (or lacks) the specific details:
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A table of acceptance criteria and the reported device performance
This specific type of table, with quantitative performance metrics against predefined acceptance criteria, is not provided in the document. The general acceptance criteria are implied by the successful completion of the listed tests and the demonstration of substantial equivalence.
Acceptance Criteria Reported Device Performance Functionality: Support mitral/tricuspid annulus, restrict expansion of the annulus Implied: Device description states it "reduce[s] and stabilize[s] the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair." Indications for Use state it "provide[s] support for the mitral or tricuspid annulus and restrict[s] expansion of the annulus." Equivalence to predicate (K905175) based on design, material, surgical technique, and intended use implies similar functionality. Biocompatibility: Safe for implantation, no adverse biological reactions Reported: "Class IV Biocompatibility tests on the predicate device." "All test results were satisfactory." (The document states these tests were done on the predicate device, implying the new device, being substantially equivalent in materials, would also be biocompatible.) Sterility: Supplied sterile, nonpyrogenic Reported: "LAL, Sterility Validation" were performed. "All test results were satisfactory." "The ATS SIMULUS FC Annuloplasty Bands are supplied STERILE (sterilized by gamma radiation) and nonpyrogenic..." Mechanical Integrity/Durability: Withstand surgical implantation and in-vivo forces without failure Reported: "Mechanical testing was carried out on complete modified bands and band components." "All test results were satisfactory." (Specific criteria like tensile strength, fatigue life, etc., are not detailed, but implied to be acceptable based on the "satisfactory" statement and equivalence to predicate.) Radiopacity: Entire circumference visible for post-implant assessment (for the FC model) Reported: "The band contains a circumferential flexible radiopaque marker. The entire circumference of the band is radiopaque." (This is a design feature, and successful visualization would be implicitly confirmed by mechanical/design verification, though no specific imaging study is mentioned as a "performance test" in the summary.) Packaging Integrity: Maintain sterility until expiration date Reported: "The bands will remain sterile until at least the expiration date provided the package is unopened and undamaged." (Successful sterility validation would cover this, but specific packaging test data is not detailed as a separate item beyond sterility validation.) Substantial Equivalence: To predicate device (K905175) Reported: "Equivalence can be seen in the design, material composition, surgical technique and intended use." FDA confirmed: "...the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the overarching "performance" criterion for a 510(k) and was met. -
Sample sized used for the test set and the data provenance
- Sample Size: Not specified for any of the tests (LAL, Sterility, Biocompatibility, Mechanical). These are typically laboratory or bench tests with samples taken from manufacturing lots, not patient-based test sets.
- Data Provenance: Not specified, but generally, for a 510(k), these would be internal laboratory tests conducted by the manufacturer or contracted third-party labs. They are not clinical studies in the sense of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as there is no "test set" in the context of human data or expert review mentioned. The tests are lab-based.
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Adjudication method for the test set
- Not applicable. No expert adjudication of a test set is mentioned.
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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
- No. This device is an annuloplasty band (implantable medical device for valve repair), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This question is not applicable as the device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests:
- Biocompatibility: Established scientific standards for biological reactivity (e.g., ISO 10993 series).
- Sterility: Established microbiology standards (e.g., USP, ISO 11137 for gamma sterilization).
- Mechanical Testing: Engineering specifications and performance comparisons to the predicate device, likely based on established ASTM or ISO standards for medical device materials and components.
- Functionality: Implied by design, material, and equivalence to the predicate device.
- For the non-clinical tests:
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The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- Not applicable. There is no "training set."
In summary:
The K052899 submission for the ATS SIMULUS FC Annuloplasty Band relies on demonstrating substantial equivalence to an existing predicate device (K905175, PTI Annuloplasty Ring / Sculptor® Annuloplasty Ring) and fulfilling standard non-clinical safety and performance testing requirements. The device is a physical implant, not an AI or diagnostic software, so many of the questions regarding clinical studies, expert review, training sets, and AI performance are not relevant to this type of device submission.
§ 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.”