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The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatic patients (greater than 12 years old).

The predicate system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The purpose of submission is to add the treatment of pediatric patients (greater than 12 years old) to this the Precice Intramedullary Limb Lengthening System indications for use. The Precice Intramedullary Limb Lengthening System includes the same devices as within the predicate Precice System (K172628) : nail, cortical screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, in K113219; ERC 2P, in K131490; or ERC 3P, in K170169; or ERC 4P, in K191336). The configurations of sets and geometry of previously cleared Precice System devices remain unchanged. The following system description is herein repeated from K172628: Precice Nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and thread styles. The ERC is available in several compatible models, including the ERC 1, ERC 2P, ERC 3P and ERC 4P. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice IMLL nail is implanted using locking screws and reusable surgical instruments.

The provided text describes a 510(k) submission for the Precice Intramedullary Limb Lengthening System, primarily focusing on expanding its indications for use to include pediatric patients (greater than 12 years old). It does not contain information about an AI/ML-driven medical device, an MRMC comparative effectiveness study, or details related to establishing ground truth by a panel of experts for a test set. Therefore, I cannot fully address all the points in your request.

However, I can extract information related to the device's acceptance criteria, study design, and performance data as presented for its 510(k) clearance. The "acceptance criteria" here are not explicitly stated in numerical thresholds, but are demonstrated through substantial equivalence to predicate devices and performance data from clinical literature and a retrospective study.

Here's a breakdown of the available information structured to best fit your request:

Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through comparison with predicate devices and clinical outcomes from two pediatric datasets (literature review and retrospective study) and one adult literature dataset. The implied acceptance criteria are that the device performs comparably or acceptably for limb lengthening, with acceptable rates of adverse events and bone healing.

Table of Reported Device Performance

Since this is not an AI/ML device with specific classification metrics, the "acceptance criteria" are implied by the comparison to predicate devices and the clinical outcomes themselves. The table below presents the key performance metrics reported in the submission.

Study Details

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

   • Pediatric Literature Review: 227 patients with 253 lengthened bones (188 femur, 53 tibia, 12 humerus). Data provenance not specified beyond "clinical literature analysis of pediatric patients." It is a retrospective summary of published data.
   • Pediatric Retrospective Study: 59 patients (59 bones) treated in the United States with the Precice Intramedullary Limb Lengthening System. This is a retrospective study.
   • Adult Literature: 136 patients with 189 bones. Data provenance not specified beyond "clinical literature analysis." This is a retrospective summary of published data.

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

   • This information is not applicable as the study involves a medical device for limb lengthening, not an AI/ML-driven diagnostic or image analysis tool requiring expert ground truth for a test set in the traditional sense of AI/ML validation. The "ground truth" for success/failure or adverse events would be derived from clinical outcomes and medical records.

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

   • Not applicable for the type of device and study described. Clinical outcomes are typically recorded directly from patient follow-ups and medical records, not through an adjudication process of interpretations by multiple experts.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML-assisted diagnostic devices, which is not the case for the Precice Intramedullary Limb Lengthening System.

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

   • Not applicable. The device is a physical intramedullary limb lengthening system, not an algorithm. Its performance is directly tied to its use in patients by surgeons.

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

   • The "ground truth" for the device's performance is based on clinical and radiographic outcomes data from patients treated with the device, derived from both retrospective studies and aggregated literature. This includes achieved limb length, bone healing rates, and the incidence of various adverse events.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "evidence" presented supports the expansion of indications based on existing clinical data and the device's similarity to predicate devices.

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

   • Not applicable as there is no training set for an AI/ML model.

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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, locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in 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 and lengths. The PRECICE® Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non sterile and must be 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-predistracted 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 PRECICE® Stryde System includes the PRECICE® Stryde Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Stryde 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 and providing internal fixation for fractures of long bones. The telescopic PRECICE® Stryde Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Stryde Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Stryde 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 reason for this submission is to introduce some design modifications to the third generation of the External Remote Controller (ERC 3P) cleared under K170169. The subject device, ERC 4P, is fourth generation of ERC component of the PRECICE® System.

The provided document is a 510(k) summary for the PRECICE® System, specifically focusing on the introduction of a new External Remote Controller (ERC 4P). It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.

However, the document does not contain any information about a study proving that an AI/device meets acceptance criteria related to classification or detection tasks, as would be typical for an AI-powered medical device. Instead, it focuses on the physical and electrical performance of a mechanical device (intramedullary fixation rod system) and its external controller.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/device for medical image analysis or similar diagnostic/detection tasks. The information required for points 1 through 9 (e.g., sample size for test set, ground truth, expert qualifications, MRMC studies, standalone performance) is not applicable to the type of device described in this 510(k) summary.

The provided text describes a mechanical device (intramedullary fixation rod) and its remote controller, not an AI or imaging device with performance criteria typically measured by metrics like sensitivity, specificity, or reader improvement.

The performance data listed in the document is for physical and electrical safety and usability, not for diagnostic or classification accuracy.

Instead, here is a summary of the type of performance data presented in the document, which are typical for electromechanical medical devices, not AI systems:

• Electrical Safety: IEC 60601-1 (3rd edition): 2005
• Electromagnetic Compatibility and Interference: IEC 60601-1-2: 2014
• Minimum rated voltage testing: (Standard not specified)
• Shock and Vibration Testing: IEC 60601-1-11:2015
• Ingress protection: (Standard not specified)
• Magnet Safety Analysis: N/A (Standard not specified)
• Usability Study: N/A (Standard not specified)
• Labeling Readability: N/A (Standard not specified)

These are engineering and safety tests, not studies of diagnostic performance.

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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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