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The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula

Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.

The provided text is a 510(k) Premarket Notification for a Cannulated Screw and Kirschner (K-wire) System, a type of orthopedic implant used for bone fixation. For this type of device, the "acceptance criteria" and "study" are not typically presented in the same way as for diagnostic AI software. Instead, the performance is demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and dimensional comparisons rather than a clinical performance study with specific metrics like sensitivity or specificity.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

Here's the information parsed from the document based on your request, with a clear indication of sections that are not applicable:

Acceptance Criteria and Device Performance Study for the Cannulated Screw and Kirschner (K-wire) System

For the Cannulated Screw and Kirschner (K-wire) System (K130613), acceptance criteria and performance were established through demonstrating substantial equivalence to legally marketed predicate devices, as is common for Class II medical devices of this nature. The "study" in this context refers to the comparison of design and material specifications rather than a clinical trial or AI performance study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. This device demonstrated substantial equivalence through comparison of design, materials, and dimensions to predicate devices, not through a "test set" of patient data in the manner of AI or diagnostic devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Ground truth in the context of expert consensus or pathological findings is not relevant for demonstrating substantial equivalence for this orthopedic implant. The "ground truth" here is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No formal adjudication method was used for a "test set" as described for AI or diagnostic performance studies. The FDA reviewed the comparison presented by the manufacturer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not applicable. This type of study is not relevant for an orthopedic implant device seeking substantial equivalence based on design and material comparisons.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices themselves, confirmed through their prior clearance by the FDA. The manufacturer provided a detailed comparison of the new device to these predicates based on:

• Design characteristics: How the screws and K-wires are constructed, their features (self-tapping, self-drilling, cannulated, thread types).
• Material composition: Type of Stainless Steel used.
• Dimensional specifications: Ranges of diameters and lengths available.

The predicate devices cited are:

• Internal Fixation Systems, Inc. Bone Fixation Devices (K071035)
• Internal Fixation Systems, Inc Cannulated Bone Screw (K061620)

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm for this orthopedic implant. The "training" for the device design would implicitly come from general engineering principles and existing knowledge of bone fixation.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, this question does not apply.

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The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.

The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones. including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of stainless steel.

This 510(k) summary describes a traditional device, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics is not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices (K110086 and K052483) based on design, material, dimensional comparison, and intended use for bone fragment fixation plates, screws, and washers.

Summary of Device and Performance Information Provided:

• Device Name: Bone Fragment Fixation Plates, Screws and Washers
• Intended Use: Internal fixation of bone fractures, fusions, or osteotomies in various anatomical locations (ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bones, and small bones). Washers are intended to prevent screw heads from breaking through the cortex by distributing forces.
• Material: Stainless steel
• Sterilization: Distributed non-sterile, to be sterilized by the end-user per AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10^-6.
• Performance Data: The submission states that the device is "substantially equivalent to the predicate devices with respect to design and material and dimensional comparison." This indicates that the performance criteria implicitly align with those of the predicate devices. No specific quantitative performance metrics or studies directly related to acceptance criteria for the new device are provided, as substantial equivalence is the primary pathway.

The following information is NOT available in the provided text, as it pertains to AI/ML powered devices and studies, which this device is not:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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