(25 days)
The Smith & Nephew Continuous Loop Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
The Smith & Nephew Continuous Loop Fixation Device is a suture loop manufactured from polyester suture. The Continuous loop is used in the same way as surgical suture with the benefit of pre-measured lengths and no need for knot tying. The device is available in 20, 40 & 60 mm.
The provided text contains minimal information about acceptance criteria or specific performance data for the Smith & Nephew Continuous Loop Fixation Device, other than general statements of substantial equivalence. Therefore, some sections of your request will be left blank or noted as "Not specified in the provided text."
Acceptance Criteria and Reported Device Performance
The submission relies on claims of substantial equivalence to a predicate device (Smith & Nephew Endobutton CL, K980155) rather than detailing specific non-inferiority or superiority criteria against established thresholds.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance metrics. The core acceptance criterion is likely demonstrating substantial equivalence to the predicate device in terms of design, materials, function, and intended use, and ensuring no new safety or efficacy issues are raised by the differences in the new device. | The performance testing conducted "demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155." It also "demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy." |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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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 or not specified. This type of device (suture loop) typically undergoes mechanical testing rather than requiring expert-established ground truth on clinical images or diagnoses.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified.
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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. This device is a medical implant, 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: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, ground truth would typically be established through mechanical performance testing (e.g., tensile strength, fatigue testing, knot security) to ensure it meets performance standards comparable to or exceeding those of the predicate device, or relevant ASTM/ISO standards for surgical sutures. The document refers to "performance testing" but does not detail the nature of this testing or the "ground truth" (i.e., expected performance outcomes) against which it was measured.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI model.
Summary of Information Gaps:
The provided 510(k) summary is typical for a predicate-based clearance of a physical device. It focuses on demonstrating substantial equivalence through comparison of characteristics and general statements about performance testing. It does not provide the detailed study protocols, specific quantitative acceptance criteria, or raw performance data that would be found in a more comprehensive clinical or engineering report. Therefore, detailed information about sample sizes for testing, ground truth methodology (beyond general mechanical testing implied), or expert involvement (as would be relevant for diagnostic AI) is not present.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.