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The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur 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 and lengths. The PRECICE Nail is supplied sterile by gamma radiation while the locking screws and PRECICE surgical instruments are supplied non-sterile and must be sterilized prior to use.

AI/ML Overview

This document is a 510(k) summary for the Ellipse PRECICE Intramedullary Limb Lengthening System (K160325). It is a letter from the FDA determining substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, focusing on the acceptance criteria and supporting studies. Please note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis typical of clinical trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or targets. Instead, it relies on demonstrating equivalence to a predicate device through various tests. The reported performance refers to the successful completion or comparability of these tests.

Test Description	Acceptance Criteria (Implicit)	Reported Device Performance
Static Torque to Failure	Comparable to predicate device and meet standard ASTM F1264 requirements.	Testing performed; conclusions of substantial equivalence drawn.
Device Functionality and Verification	Demonstrate proper operation and intended function.	Testing performed; conclusions of substantial equivalence drawn.
Sterilization Validation	Validated to achieve sterility.	Applicable from predicate device testing.
Shelf Life Testing	Maintain packaging integrity and device functionality over time.	Applicable from predicate device testing.
Biocompatibility Testing	Biocompatible for intended use.	Applicable from predicate device testing.
ASTM F1264 (Intramedullary Rods)	Conform to standard requirements for intramedullary rods, comparable to predicate devices.	Applicable from predicate device testing. Additional static torque testing performed.

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

The document does not specify sample sizes for the mechanical tests (Static Torque to Failure, Device Functionality). For sterilization, shelf-life, and biocompatibility, it states these were "applicable" from the predicate device testing (K151131). The data provenance is implied to be from laboratory testing rather than human clinical data, and the type is retrospective as it relies on past predicate device testing and new tests specifically for the line extension. There is no mention of country of origin for the data, but it's presumed to be from Ellipse Technologies, an American company.

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

This information is not applicable as the document describes bench and mechanical testing, not a clinical study involving expert assessment of outputs for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench and mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intramedullary rod) and not an AI or imaging diagnostic device where such studies are typical. The focus is on mechanical and functional equivalence to a predicate device, not on diagnostic accuracy improvements or human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical implant and does not involve an algorithm or AI component in the typical sense of standalone performance evaluation.

7. The Type of Ground Truth Used

For the mechanical tests (Static Torque to Failure, Device Functionality, ASTM F1264), the ground truth is based on engineering standards and design specifications, ensuring the device performs as intended and withstands specified forces. For biocompatibility, sterilization, and shelf-life, the ground truth is established by validated laboratory methods and relevant industry standards/regulations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" would be used for algorithm development. The testing described focuses on validating the physical device's characteristics.

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

Not applicable for the reasons stated above.

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