(43 days)
The Scandius TriTis Absorbable Tibial Reconstruction System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstructions of the knee.
The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization trav.
Here's an analysis of the provided text regarding the Scandius TriTis Absorbable Tibial Reconstruction System, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance (Based Solely on Provided Text):
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Ultimate failure strength | "demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness." (Implies meeting or exceeding predicate's performance) |
| Biocompatibility/Material | Absorbable material properties | Device described as "Absorbable," implying the material meets requirements for an absorbable implant. |
| Intended Use | Fixation of ligament/tendon grafts for ACL reconstruction | Device has the "same intended and indication for use" as the predicate. |
| Technical Characteristics | Similar to predicate device | "have similar technical characteristics and principles of operation." |
Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions "Bench testing," which implies laboratory conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. "Bench testing" suggests a non-human-reader-based evaluation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the described study is "Bench testing" and does not involve human interpretation or a "test set" in the context of diagnostic performance.
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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, an MRMC comparative effectiveness study was not done. This document describes a medical device for surgical reconstruction, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a "standalone" performance evaluation was done in the form of "Mechanical ultimate failure strength" bench testing. This is an assessment of the device's physical properties without human intervention.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the bench testing would be engineering specifications and established biomechanical standards for ultimate failure strength for such devices, likely derived from predicate devices or industry benchmarks.
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The sample size for the training set:
- Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device is a physical implant, not an AI algorithm.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.