SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW by SMITH & NEPHEW, INC.

The Smith & Nephew GTS Sleeve and GTS Tapered Screw consist of two (2) components, the sleeve and screw. The sleeve manages, protects, and separates the graft tendon bundle and creates a central path for concentric placement of the tapered screw, which forces a larger surface area of the tendons against the tibial tunnel wall within a surgically created tunnel.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and a study to prove device performance:

Based on the provided text, the device in question is "The Smith & Nephew GTS Sleeve and GTS Tapered Screw". This document is a 510(k) Summary of Safety and Effectiveness, which is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical or stand-alone performance study in the way a newer, non-equivalent device might.

Therefore, many of the requested points regarding sample sizes, ground truth, expert opinions, and MRMC studies are not explicitly detailed in this type of submission. The performance here is assessed by comparing technological characteristics and "in vitro performance testing" to establish equivalence.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined in terms of specific performance metrics (e.g., tensile strength, fixation force) with corresponding pass/fail thresholds in this summary. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance data supports this equivalence.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
1. Same Intended Use: The device must be indicated for the same use as the predicate devices.	Met: "The Smith & Nephew GTS Sleeve and GTS Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction." This matches the implied intended use of the predicate devices.
2. Similar Technological Characteristics: The device should share similar design features, materials, and operational principles with the predicate device. This includes:	Met:

Multi-channeled, single construct: Both the GTS Sleeve/Screw and the Intrafix™ Tibial Sheath and Tapered Screw employ this design.
Central screw placement: Both designs allow for this.
Tapered screw for fixation: Both use a tapered screw to create final fixation.
Bioresorbable components: The GTS Tapered Screw is bioresorbable, similar to predicate devices (K032224 and K992396 BioRCT® Screws).
Similar Geometries and Range of Sizes: Implied to be similar to the predicate.
Single patient use & EO sterilized: Both share these characteristics. |
| 3. Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is supported by:
In vitro performance testing: To demonstrate functional equivalence and appropriate mechanical properties.
Material biocompatibility: To ensure the materials used are safe for implantation.
Sterilization validation: To confirm the device can be effectively sterilized without compromising safety or performance.
Clinical performance (implied): While not a separate clinical study, the substantial equivalence implies that if the predicate is safe and effective, and the new device is sufficiently similar, it also meets these criteria. | Met: "The in vitro performance testing, material biocompatibility and sterilization validation demonstrate the device is safe, effective for its intended use, and supports a decision of substantial equivalence." (Specific results of these tests are not detailed in this summary.) |

Study Details from the Provided Text:

The provided text describes a 510(k) Premarket Notification process, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish novel acceptance criteria and meet them.

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are implied by the requirements for substantial equivalence. "Reported device performance" is a summary statement of having met these criteria through various tests.
Sample size used for the test set and the data provenance:
- Not specified in the provided text. The text mentions "in vitro performance testing," "material biocompatibility," and "sterilization validation." These typically involve testing a specific number of device samples or material specimens according to relevant standards, but no specific sample sizes are given.
- Data Provenance: The document is dated March 1, 2004, from Smith & Nephew, Inc., Endoscopy Division, located in Andover, MA, USA. The testing would have been conducted to support this submission, likely within the manufacturer's R&D or quality assurance facilities, possibly in the USA. It would be considered prospective for the purpose of this submission, meaning the tests were performed to gather data for this specific regulatory filing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Clinical expert consensus for ground truth is typically relevant for diagnostic devices or observational studies. This submission focuses on a mechanical fixation device and its equivalence to predicates through in vitro (bench) testing, material analysis, and sterilization.
Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation). This submission details in vitro testing.
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 mechanical bone fixation device, not an AI-assisted diagnostic or decision support tool, and the submission does not describe a clinical comparative effectiveness study involving "human readers" or "AI."
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro performance testing, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM or ISO standards for mechanical properties like pull-out strength, torque resistance, fatigue life, or material biocompatibility standards). The results of these tests are compared against pre-defined engineering requirements or directly against the predicate device's known performance characteristics (if publicly available or previously established).
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device. Training sets are relevant for machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implied acceptance criteria (substantial equivalence) consists of bench testing (in vitro performance testing), material biocompatibility testing, and sterilization validation. The specific details of these tests (e.g., exact protocols, number of samples for each test, detailed results) are not provided in this 510(k) summary but would be present in the full 510(k) submission document. The summary broadly states that these tests demonstrate safety and effectiveness for its intended use, supporting the decision of substantial equivalence to the identified predicate devices (Intrafix™ Tibial Sheath and Tapered Screw, and Smith & Nephew BioRCT® Screws K032224 & K992396).

Summary

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.