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

The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments. The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.

The provided text is a 510(k) summary for the PRECICE Plating System, a medical device for orthopedic indications. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical performance data.

However, the document does not contain information regarding acceptance criteria for device performance in the context of clinical studies, sample sizes for test sets or training sets, ground truth establishment methods (expert consensus, pathology, etc.), details about human expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

The provided text details non-clinical performance verification, establishing substantial equivalence to existing predicate devices through mechanical testing and engineering analysis. It lacks the elements typically associated with proving device performance against specific acceptance criteria in a clinical setting, particularly for AI/machine learning devices where the requested information is highly relevant.

Therefore, many of the requested fields cannot be filled from the given document.

Here's a breakdown of what information can and cannot be extracted based on your request:

Summary of Device Performance (Based on "Performance Data" section):

The "Performance Data" section describes non-clinical testing performed to demonstrate substantial equivalence. The device's performance is reported in terms of its ability to perform "substantially equivalent" to predicate devices under various mechanical tests.

Table of Performance (Based on H. Performance Data section):

Conclusion from document: The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.

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The PRECICE® BONE TRANSPORT™ 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 System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

The provided text is a 510(k) summary for the PRECICE® BONE TRANSPORT™ System. It details the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study involving a comparison of the device's performance against detailed acceptance criteria using metrics such as sensitivity, specificity, or accuracy in a clinical or diagnostic context.

Instead, the document focuses on non-clinical performance verification testing to demonstrate functional substantial equivalence to a predicate device. Therefore, I cannot provide the information requested in the prompt as it pertains to a clinical efficacy study with acceptance criteria and reported device performance in terms of diagnostic or clinical metrics.

Here's a breakdown of why the requested information cannot be fully provided based on the given text:

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

   • The document lists various non-clinical tests (Static Compression, Dynamic Compression Bending strength, Torsion, Torque Resistance, Axial Pullout, Biocompatibility, Sterilization, Package Distribution, Distraction Force Testing, Retention Force Testing, Fluid Ingress Testing, Biomechanical Axial Compression Testing).
   • It also lists the applicable standards (e.g., ASTM F1264, ASTM F543, ISO 10993, ISO 11137).
   • However, it does not provide specific numerical acceptance criteria for each test (e.g., "must withstand X N of force") nor does it report the actual numerical device performance results (e.g., "device withstood Y N of force"). It only states, "The results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate device." This is a qualitative statement of equivalence, not a quantitative report against specific acceptance criteria.
   • Crucially, these are engineering/mechanical/material performance criteria, not clinical diagnostic performance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. The tests are non-clinical, likely involving a certain number of device samples rather than patient data. The document does not specify the number of device samples or their "provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no human "ground truth" establishment in these non-clinical engineering tests.

4. Adjudication method: Not applicable for non-clinical engineering tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is for evaluating human interpretation of diagnostic data, often with AI assistance. The device in question is an intramedullary fixation rod, not a diagnostic imaging AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established by the physical properties and performance characteristics dictated by the ASTM/ISO standards and internal design specifications. There's no clinical ground truth (like pathology or outcomes data) mentioned.

8. The sample size for the training set: Not applicable. There is no AI model or training set described.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance document is for a physical medical device (intramedullary fixation rod) and details non-clinical engineering and material performance tests to establish substantial equivalence, not a clinical study involving AI or diagnostic performance metrics.

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