(29 days)
The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.
The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band:
- The end of the stiffener section at the posteroseptal commissure.
- The anteroposterior commissure. ●
- The end of the stiffener section in the anterior segment of the band. ●
A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.
The provided document is a 510(k) summary for a medical device called the "Tri-Ad™ 2.0 Adams Tricuspid Band." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way one might see for novel technologies or AI algorithms.
Therefore, the document does not contain the acceptance criteria or a study proving it meets those criteria in the traditional sense of a clinical trial or performance validation for an AI device. Instead, the submission describes the device, compares it to a predicate device, and lists the types of verification testing performed to demonstrate fundamental safety and performance.
Here's an analysis based on the information provided, explaining why certain sections cannot be filled:
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A table of acceptance criteria and the reported device performance
This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence through design characteristics and verification testing, rather than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) that an AI device would typically have, or reporting specific clinical outcomes against quantitative targets.
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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 applicable/not present in the document. The "tests" mentioned (Visual Inspection, Biocompatibility, Sterilization, Design Validation / Human Factors Engineering) are engineering and technical verification tests, not clinical performance studies that would involve test sets 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 (e.g., radiologist with 10 years of experience)
This information is not applicable/not present. Ground truth, in the context of clinical performance, is not discussed as there were no clinical performance studies involving interpretation of data by experts. The "ground truth" for the device's characteristics would be established through engineering specifications and material testing standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not present. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for a diagnostic or AI-assisted task. This document details a medical device, not an AI diagnostic tool.
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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
This information is not applicable/not present. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance. The Tri-Ad™ 2.0 Adams Tricuspid Band is an annuloplasty ring, a physical implantable device, and not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not present. This refers to the performance of an AI algorithm in isolation. The described device is a physical medical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not present in the context of clinical performance. For the engineering tests mentioned (Biocompatibility, Sterilization, etc.), the "ground truth" would be established by validated test methods and established standards confirming material properties, sterility, etc.
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The sample size for the training set
This information is not applicable/not present. "Training set" refers to data used to train an AI model.
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How the ground truth for the training set was established
This information is not applicable/not present. This refers to the process for annotating data for AI model training.
Summary of Device Acceptance/Equivalency:
The document focuses on demonstrating substantial equivalence to a predicate device (Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring, K093903). The "acceptance criteria" are implied by the regulatory framework for 510(k) submissions: the device must be as safe and effective as a legally marketed predicate device.
The study that "proves" the device meets these (implied) criteria consists of:
- Comparison to Predicate Device: The document highlights that the Tri-Ad 2.0 Adams tricuspid band is "identical" to the predicate in Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging, and Size Range. Minor modifications are noted in product labeling but are deemed substantially equivalent.
- Verification Testing: A list of performed studies is provided:
- Visual Inspection
- Biocompatibility
- Sterilization
- Design Validation / Human Factors Engineering
The conclusion states that "Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device."
In essence, the "acceptance criteria" here are regulatory (substantial equivalence), and the "study" is a combination of direct comparison to a predicate and basic engineering verification tests demonstrating that the device itself, and the minor modifications, do not introduce new questions of safety or effectiveness.
§ 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.”