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The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads. The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD. ASTM F138. The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures. The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.

This document is a 510(k) summary for the "Pin Screw" device, seeking regulatory clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot extract the requested information from the provided text as the document focuses on regulatory submission and equivalence, not a performance study.

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The DePuy Cannulated Cross Pin Screws are intended to provide early fixation of autogenous or allogeneic tendon grafts in surgical procedures for anterior cruciate ligament (ACL) reconstruction.

The DePuy Cannulated Cross Pin Screw System contains cross pin screws manufactured from titanium alloy which are headless, proximally threaded with smooth shanks containing two tapers; the most distal taper being the smaller diameter tapering to a blunt tip. They are cannulated for use with their accompanying guide pins. The cross pin screws will be available in seven lengths ranging from 45mm to 75mm in 5mm increments.

This document is a 510(k) summary for a medical device (DePuy Cannulated Cross Pin Screw System), not a study evaluating software or AI performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and reader performance is not applicable to this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • This document does not specify quantitative acceptance criteria or reported device performance in the way a study for a diagnostic or AI-based device would. The "performance" described here is primarily related to its design, material, and intended use for mechanical fixation.
   • The basis of substantial equivalence is not a performance study in the sense of accuracy, sensitivity, or specificity. Instead, it's based on "similar material, intended uses and design" to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. This is a submission for a physical medical device, not a data-driven study.

3. 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. Ground truth for a physical fixation pin would typically involve mechanical testing, clinical outcomes (if a clinical study were done, which is not described here as part of substantial equivalence), or comparison to predicate device specifications, not expert consensus on data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable.

5. 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 is not an AI or diagnostic device summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For a physical medical device like this, the "ground truth" for substantial equivalence is primarily based on:
     • Material properties: Chemical composition, mechanical strength.
     • Design specifications: Dimensions, cannulation, thread design, tapers.
     • Intended use statement: How it will be used in surgery.
   • These are compared to predicate devices, and the equivalence is asserted based on these shared attributes, rather than a "ground truth" derived from patient data or expert interpretation.

8. The sample size for the training set

   • Not applicable. There is no training set mentioned or implied.

9. How the ground truth for the training set was established

   • Not applicable.

In summary, the provided document is a regulatory submission for a physical orthopedic device establishing substantial equivalence, not a performance study of a diagnostic, AI, or software-based medical device. Therefore, the questions related to data sets, ground truth, and reader studies are not relevant to this content.

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