(134 days)
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
SteriTrak™ is a sterile, temporarily implantable Kirschner wire (K-wire). SteriTrak™ is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrak™ is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrak™ is removed.
The SteriTrak™ surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrak™ is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.
The provided text is a 510(k) summary for the SteriTrakTM device, a skeletal traction pin. It focuses on establishing substantial equivalence to predicate devices based on intended use, design, technological characteristics, and non-clinical performance testing. However, it does not contain information about acceptance criteria or a study that utilizes AI/ML for medical image analysis, which is the premise of your request.
Specifically, the document does not provide the following information from your prompt:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample size used for the test set or data provenance for an AI/ML study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with AI assistance.
- Details about standalone (algorithm only) performance.
- The type of ground truth used (expert consensus, pathology, outcomes data) for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How the ground truth for the training set was established for an AI/ML model.
The document describes non-clinical performance testing such as:
- Biocompatibility assessment to ISO 10993-1
- Usability testing to IEC 62366-1
- Pin torque transfer to ASTM F-138-19 and ISO 5832-1
- Label legibility testing to ISO 14630:2012
These tests are standard for a medical device cleared via the 510(k) pathway, demonstrating mechanical, biological, and user interface safety and efficacy, but they are not related to AI/ML performance evaluation.
§ 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.