(269 days)
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surqically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions:
- Diaphyseal facture of the femur, tibia and humerus .
- Fractures of the femoral neck .
- . Subtrochanteric, intertrochanteric and combination fractures
- . Correction of deformities (OI, Coxa vara, Coxa valga)
- . Nonunions and malunions
The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via and/or mechanical screws creating a a combined laq Endoamedullary/ Exomedullary osteosythesis device. 3 and 4mm cortical screws are used to secure the nail to the bone.
The provided document describes the GAP Endo-Exo Medullary System, an intramedullary nail system for pediatric patients. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific acceptance criteria and device performance as would be expected for an AI/ML medical device.
Therefore, many of the requested sections regarding AI/ML study specifics (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it pertains to a mechanical medical device with no AI/ML component described.
Here's the information that can be extracted from the provided text, adapted for the context of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| ASTM Standard 1264: Static 4-point bending test | Results indicated the device is functionally safe for its intended use. |
| ASTM Standard 1264: Torsion test | Results indicated the device is functionally safe for its intended use. |
| ASTM Standard 1264: 4-point bending fatigue test | Results indicated the device is functionally safe for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The tests were biomechanical, likely using multiple samples of the device and possibly bone simulants or cadaveric bone, but specific numbers were not provided.
- Data Provenance: The tests were "Biomechanical Testing" performed to demonstrate safety. The document does not specify the country of origin of the test data (e.g., where the lab was located), nor does it indicate if the data was retrospective or prospective in a clinical sense, as these were laboratory biomechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the document describes a mechanical device. "Ground truth" in the context of biomechanical testing typically refers to established engineering principles, material properties, and adherence to test standards, rather than expert consensus on medical images or diagnoses. The expertise would lie in the conducting and interpretation of the biomechanical tests according to ASTM standards.
4. Adjudication method for the test set
- This question is not applicable as the document describes a mechanical device. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions on diagnoses or image interpretations, which is not relevant to biomechanical testing of an intramedullary nail.
5. 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
- This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm or software. No MRMC study was conducted or described, nor would it be relevant for this type of device. The document explicitly states: "No clinical testing was provided as a basis for substantial equivalence. A clinical data report based on equivalent products can be found in Appendix H." This further confirms that no clinical studies (including those involving human readers or AI assistance) were part of the submission for this particular device's performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm.
7. The type of ground truth used
- For the biomechanical tests, the "ground truth" was based on adherence to the specified ASTM standard 1264 "Standard Specifications and Test Method L for Intramedullary Fixation Devices" and the resulting performance (strength, durability) being within acceptable ranges for safety and intended use. This is a scientific/engineering ground truth defined by established test methods and safety criteria.
8. The sample size for the training set
- This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable. The device is a mechanical intramedullary nail, not an AI/ML algorithm that requires a training set.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.