(28 days)
Approximation of soft tissue
The LSI "R" Series Suturing Device and Accessories Product, like the predicate, is intended for the approximation or ligation of soft tissue by passing ligature through said soft tissue.
This looks like a 510(k) premarket notification for a surgical instrument, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth establishment (which are typical for AI/ML device evaluations) are not present in the provided document.
The document describes a traditional medical device submission for the LSI "R" Series Suture Placement Device and Accessories Product. Its purpose is to demonstrate substantial equivalence to a predicate device (LSI Suture Placement Device and Accessories (K981531)).
Here's how to interpret the provided information in the context of a traditional device submission:
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A table of acceptance criteria and the reported device performance: This type of table is not directly applicable to this traditional device submission. For such devices, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:
- Indications for Use: Both the new device and the predicate device have the same indication: "Approximation of soft tissue."
- Technological Characteristics: The new device, like the predicate, is described as a "Manual surgical instrument for general use" intended for "passing ligature through said soft tissue." The submission would contain detailed comparisons of materials, design, manufacturing processes, and performance characteristics (e.g., tensile strength, biocompatibility, sterilization validation) to support this claim, but these details are not provided in the summary.
- Safety and Effectiveness: Substantial equivalence implies that the new device is as safe and effective as the predicate. This is typically established through non-clinical bench testing, and sometimes animal studies, but generally not human clinical trials for simple instruments compared to highly similar predicates.
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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): Not applicable for this type of submission. There isn't a "test set" in the AI/ML sense. Substantial equivalence is often supported by engineering tests and comparisons.
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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): Not applicable. There is no ground truth in the sense of expert annotation for a medical image or diagnostic task.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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, as this is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a traditional surgical instrument would be its ability to perform its intended function safely and effectively, as demonstrated by engineering tests and conformance to standards, not by comparison to expert-labeled data.
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The sample size for the training set: Not applicable, as there is no AI/ML model to train.
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How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The LSI "R" Series Suture Placement Device and Accessories Product gained FDA clearance (K040232) based on its substantial equivalence to a previously legally marketed predicate device (LSI Suture Placement Device and Accessories, K981531). The key elements for this determination were:
- Identical Intended Use: Both devices are intended for "Approximation of soft tissue."
- Similar Device Description: Both are manual surgical instruments for general use for passing ligatures through soft tissue.
The "acceptance criteria" implicit in this type of submission are that the new device must share the same intended use and similar technological characteristics with a predicate device, and any differences in technological characteristics must not raise new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" would have been a comparative analysis (not a clinical study in the AI/ML sense) demonstrating this substantial equivalence, likely through bench testing and detailed engineering comparisons, the specifics of which are not detailed in this summary document.
§ 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.