(42 days)
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.
The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane.
This 510(k) submission for the OrthoGuard AB Antimicrobial Sleeve does not contain specific acceptance criteria or a detailed study description that proves the device meets such criteria. Instead, it relies on the concept of substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
No explicit acceptance criteria or a table of performance metrics are provided in the document. The submission states: "The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices." This implies that the performance was considered "equivalent enough" to the predicate, but specific quantitative acceptance criteria or performance numbers are not given.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" or specific study data is provided. The document relies on comparison to a predicate device rather than a new standalone clinical or performance study with a distinct test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No new test set requiring expert ground truth establishment is described. The submission focuses on substantial equivalence to a previously approved device.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring an adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for devices involving human interpretation of medical images or data, which is not the case for an antimicrobial sleeve.
6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product (an antimicrobial sleeve), not an algorithm or AI system. Therefore, an "algorithm only" performance study is irrelevant.
7. The Type of Ground Truth Used:
The "ground truth" here is effectively established by the predicate device's prior approval and its demonstrated safety and effectiveness in its intended use. The new device is deemed substantially equivalent to that established "ground truth." There is no new, independent establishment of ground truth for bacterial colonization inhibition mentioned for the OrthoGuard AB Antimicrobial Sleeve itself in this document, beyond its comparison to the predicate.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is not an AI/ML device.
Summary of Approach in this 510(k) Submission:
This 510(k) submission for the OrthoGuard AB Antimicrobial Sleeve is based entirely on substantial equivalence to a previously cleared predicate device (OrthoGuard AB Antimicrobial Pin Sleeves, K012193). The rationale for equivalence is that the new wire sleeve has the "same" intended use, material, coating formulation, manufacturing, coating method, labeling, and sterilization method as the predicate. Any differences were deemed not to significantly affect safety or effectiveness.
Therefore, the "acceptance criteria" were implicitly met by demonstrating that the new device is functionally and materially similar enough to a device already accepted by the FDA. The "study" proving this is essentially the comparison analysis outlined in the "Technological and Performance Characteristics" section, which concluded that the differences were not significant. No new, independent studies with specific performance endpoints, test sets, or ground truth establishment are detailed in this summary.
§ 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.