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

The PRECICE System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non-sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is offered in pre-distracted and non-pre-distracted models. Pre-distracted models are supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques

The provided text is related to a 510(k) premarket notification for the "PRECICE System," an intramedullary fixation rod. This submission is for a medical device cleared through the FDA's 510(k) pathway, which establishes substantial equivalence to a predicate device rather than proving clinical effectiveness in the same way clinical trials for drugs or novel devices might.

Therefore, the input document does not contain the information requested in points 1-9 because the regulatory pathway for this device (510(k) substantial equivalence) does not typically involve the types of studies, acceptance criteria, or performance metrics (like sensitivity, specificity, AUC) associated with AI/ML solutions or devices requiring a de novo or PMA pathway that directly measure clinical outcomes or diagnostic accuracy against a ground truth in a clinical setting.

Instead, the document details a comparison of the subject device (PRECICE System) to predicate devices (e.g., PRECICE UNYTE System, PRECICE Intramedullary Limb Lengthening System) based on:

• Indications for Use: The subject device has similar indications for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. The submission explicitly states its intent to align indications with the predicate devices.
• Technological Characteristics & Principles of Operation: Both the subject and predicate devices utilize the same design for the intramedullary nail, are inserted similarly, secured with locking screws, and adjusted non-invasively by an External Remote Controller (ERC).
• Testing: The document states, "There are no design, technological or performance changes to the PRECICE Nail being made as a result of this submission as the PRECICE System is identical to the PRECICE UNYTE System, therefore all testing that was performed on the predicate PRECICE UNYTE Nail and PRECICE Systems previously cleared, are applicable." This means the substantial equivalence is based on prior testing of the predicate devices.

In summary, none of the requested information (acceptance criteria, specific study design details, expert involvement for ground truth, sample sizes for training/test sets, or MRMC studies) can be extracted from this document because it describes a 510(k) submission based on substantial equivalence rather than a clinical performance study with specific metrics as would be required for an AI/ML device.

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The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.

The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with specific numerical targets. The "acceptance criteria" here are implied to be that the new device components (new screw thread styles) maintain the same or similar performance characteristics as the predicate device's existing components.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a separate "test set" for this submission. The document states that testing was previously performed on the predicate components and on the same screws used in a reference device (K160267). The specific number of screws or nails tested in those prior studies is not mentioned.
   • Data Provenance: Not explicitly stated. The document refers to prior testing, but doesn't specify the country of origin or if the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not mentioned. This submission focuses on engineering and biocompatibility testing (mechanical, pyrogen), not on clinical performance evaluated by experts with patient data.

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

   • Not applicable/None. As this is not a clinical study involving expert interpretation, there is no adjudication method.

4. 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 a medical device for bone lengthening, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

   • Not applicable. This is a physical implantable device, not an algorithm.

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

   • Ground Truth for Mechanical Testing: Adherence to established ASTM standards (material properties, strength, fatigue resistance, etc.) defining acceptable performance for orthopedic implants and screws.
   • Ground Truth for Pyrogen Testing: Compliance with ANSI/AAMI ST72:2011 specifications for bacterial endotoxins.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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