(92 days)
The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
The subject device combines two cleared devices (i.e., EndoButton CL Ultra and GTS Tapered Screw) into disposable kits along with the necessary disposable instruments to perform cruciate ligament reconstruction procedures. Both the EndoButton CL Ultra and GTS Tapered Screw provided in the ACL SMART System are identical in design to the previously cleared predicate devices. However, the GTS Tapered Screw was originally cleared for use with the GTS Sleeve and the GTS Tapered Screw in the ACL SMART System is intended to be used independent of the sleeve.
The provided text describes a 510(k) premarket notification for the "ACL SMART System" by Smith & Nephew, Inc. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and performance characteristics, supported by non-clinical bench (mechanical) testing. It explicitly states: "non-clinical bench (mechanical) testing was conducted on the GTS Tapered Screw without the GTS sleeve. Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device."
Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text, as the information is not present. Here's what I can extract and what is missing:
Summary of Acceptance Criteria and Device Performance (Based on Provided Text)
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (From Preclinical Testing Summary) |
|---|---|
| Functionality and safety comparable to predicate devices. | Substantially equivalent to previously cleared BioRCI Screw. |
| Fixation strength comparable to predicate devices. | Met fixation strength requirements in bench testing. |
| Insertion characteristics comparable to predicate devices. | Met insertion requirements in bench testing. |
Detailed Information on the Study (Missing for most points)
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms within this document. The document relies on substantial equivalence to predicate devices rather than specific performance thresholds.
- Reported Device Performance: The document states that "Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device" for "Fixation strength" and "Insertion". No specific numerical performance values or comparative metrics are provided.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "non-clinical bench (mechanical) testing."
- Data Provenance: The tests were "non-clinical bench" conducted by the manufacturer, Smith & Nephew, Inc. The country of origin of the data is not specified, but the company is based in Andover, Massachusetts.
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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 was a non-clinical bench study, not involving human experts for ground truth establishment in a diagnostic context. The "ground truth" would be the mechanical properties being measured (e.g., actual fixation strength, insertion force).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As a mechanical bench test, there would be no adjudication method involving human interpretation.
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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 a surgical fixation system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical implant system, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this mechanical bench testing would be the actual physical/mechanical properties measured according to engineering standards (e.g., tensile strength, displacement under load, torque for insertion). It's based on objective physical measurements rather than clinical interpretations like pathology or expert consensus.
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The sample size for the training set:
- Not applicable. As a physical device undergoing mechanical testing, there is no "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 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.