(364 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. The OrthoGuard AB Antimicrobial Sleeve is provided at a maximum length for the longest pin/wire length and can be cut to desired lengths for smaller lengths of pins and wires selected for bone fixation. OrthoGuard AB Antimicrobial Sleeves are available in splined (longitudinal internal ridges for interference fit) or non-splined design in various diameters to match currently marketed orthopaedic pin/wire diameters.
The provided text describes a medical device, the OrthoGuard AB Antimicrobial Sleeve, and its FDA 510(k) submission for market clearance. However, it does not contain the specific details required to answer the prompt regarding acceptance criteria and the study proving the device meets those criteria.
The document lists various performance characteristics that the device was subjected to (in-vitro elution tests, in-vivo elution tests, ETO sterilization study, packaging integrity test, etc.), and states that "The data from these tests support the safety and effectiveness of the device and substantial equivalence to legally marketed devices."
Crucially, the document does not:
- Define specific acceptance criteria (e.g., "bacterial colonization inhibition must be X% over Y days").
- Report quantitative device performance against those criteria.
- Provide details on sample sizes, ground truth establishment, expert involvement, or any comparative effectiveness studies.
Therefore, I cannot complete the table or the other requested points based on the provided text. The document is a 510(k) summary, which generally focuses on justification for substantial equivalence, rather than detailed study results and acceptance criteria.
Based on the provided text, the following information is NOT available to answer your request:
- A table of acceptance criteria and the reported device performance: Not specified.
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as ground truth typically refers to objective biological or clinical outcomes, not expert consensus for this type of device.
- Adjudication method for the test set: Not applicable, as expert adjudication is usually for subjective image interpretation, not for device performance like antimicrobial efficacy.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this type of study is for diagnostic devices, not for a physical device like an antimicrobial sleeve.
- If a standalone study was done: The document mentions "performance characteristics" and various in-vitro and in-vivo tests, implying studies were done to assess the device itself, but specific details of "standalone" performance (e.g., without human-in-the-loop, which is irrelevant for this device) are not provided.
- The type of ground truth used: For antimicrobial efficacy, ground truth would typically be microbiological cultures or quantitative bacterial counts. This is implied by "microbial activity tests" and "antimicrobial release rate tests," but the specific type of ground truth and how it was established are not detailed.
- The sample size for the training set: Not applicable; this device is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable; this device is not an AI/ML algorithm.
§ 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.