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The Precice® Screws are provided sterile and intended to be used with the systems below:

The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.

The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs.

The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).

Here's an analysis of the provided text, focusing on the acceptance criteria and study information related to the Precice® Screws.

It's important to note that the provided document is a 510(k) summary for a medical device (Precice Screws) intended to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the regulatory process and claims of equivalence rather than a detailed clinical study demonstrating new performance attributes against specific acceptance criteria for a novel device. The "performance data" section is very brief and refers to validation studies for sterilization and packaging, not clinical or functional performance of the screws themselves in a patient.

Acceptance Criteria and Study for Precice® Screws (K193617)

Given the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily regulatory in nature (demonstrating substantial equivalence to a predicate device) rather than clinical performance metrics for a novel technology. The "study" mentioned refers to validation testing for the sterilization and packaging of the screws, not a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

• Equivalent design
• Equivalent labeling/intended use
• Equivalent material composition
• Equivalent function | The subject Precice® Screws were shown to be substantially equivalent to the predicate devices (Precice® System K172628, Precice® Stryde System K180503, Precice® Bone Transport K182170, and Precice® Plate System K192181) through comparison in these areas. |
  | Sterility:
• Product must be sterile | Gamma sterilization validation was performed. |
  | Sterile Packaging:
• Packaging maintains sterility
• Sterile barrier integrity over time | Sterile packaging validation and integrity of the sterile barrier over time validation were performed. |

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

• Test Set Sample Size: Not specified in the document. The "tests" here refer to validation studies (sterilization, packaging), not clinical trials with patient data.
• Data Provenance: Not applicable in the context of clinical/patient data. The studies are laboratory/engineering tests performed by the manufacturer.

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

• Number of Experts: Not applicable. These are validation studies, not studies relying on expert interpretation of clinical data to establish ground truth.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to validation studies, not studies where human interpretation of medical data requires adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study investigates the performance of human readers, sometimes with and without AI assistance, which is outside the scope of this 510(k) submission for a fixation screw.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a surgical screw, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the regulatory submission, the "ground truth" for substantial equivalence was established by comparing the characteristics of the subject device (Precice® Screws) against the characteristics of the legally marketed predicate devices. For the validation studies, the ground truth would be accepted engineering and scientific standards for sterility and packaging integrity.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device (screws) and its manufacturing/sterilization processes, not an AI or algorithm that would require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Document's Research Focus:

The provided document, a 510(k) summary, is not a clinical study report evaluating the performance of a device or algorithm in a patient population. Instead, it is a regulatory document to demonstrate that the Precice® Screws, specifically a new sterile option for previously cleared screws, are substantially equivalent to existing cleared predicate devices. The "performance data" referenced relates to validation studies for manufacturing processes (sterilization and packaging), which are necessary to ensure the safety and efficacy of the product as a sterile medical device, rather than studies evaluating the clinical effectiveness of the screw design itself.

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