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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, malunions, 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 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 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 provided text is a 510(k) premarket notification letter and summary for the PRECICE System, an intramedullary fixation rod. It describes the device, its indications for use, and argues for its substantial equivalence to a previously cleared version of the PRECICE System.

However, the document does not contain information about:

• Acceptance criteria for device performance (e.g., accuracy, precision, reliability metrics).
• Any specific test studies proving performance against acceptance criteria.
• Sample sizes used for test or training sets for an AI/algorithm-based device.
• The number or qualification of experts, or ground truth adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used.
• How ground truth for a training set was established.

This document focuses on regulatory approval, particularly emphasizing the substantial equivalence of a modified device (material change to stainless steel) to an already cleared predicate device. It highlights that no changes were made to the design, technological characteristics, or principles of operation, and that previous testing on the existing components remains applicable.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The device in question is a mechanical intramedullary fixation rod, not an AI or algorithm-based medical device that would typically involve the types of studies and criteria mentioned in your request (e.g., image analysis, 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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