(134 days)
The Restore™ Fixation System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
The Restore™ Fixation System consists of a compression staple and two non-locking cortical screws (one for optional use) with surgical site preparation and insertion instruments. The compression staple and cortical screw are fabricated from medical grade stainless steel alloy (ASTM F-139 and F-138) and are pre-packaged sterile.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Restore™ Fixation System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details mechanical testing performed to demonstrate substantial equivalence, rather than specific acceptance criteria with pass/fail values. The "Performance Data" section states that testing was done "as described in relevant recognized standards." Without the specific standards or their defined criteria and the numerical results, a precise table with acceptance criteria is not possible. However, based on the general information, we can infer the tested parameters.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Compression Staple (per ASTM F-564): | |
| 4-point bending (static) performance | Mechanical testing performed; device met performance described in ASTM F-564 for 4-point bending (static). (Specific numerical results not provided in this summary.) |
| 4-point bending (dynamic) performance | Mechanical testing performed; device met performance described in ASTM F-564 for 4-point bending (dynamic). (Specific numerical results not provided in this summary.) |
| Pull-out force performance | Mechanical testing performed; device met performance described in ASTM F-564 for pull-out force. (Specific numerical results not provided in this summary.) |
| Non-locking Cortical Screw (per ASTM F-543): | |
| Torque to failure performance | Mechanical testing performed; device met performance described in ASTM F-543 for torque to failure. (Specific numerical results not provided in this summary.) |
| Pull-out force performance | Mechanical testing performed; device met performance described in ASTM F-543 for pull-out force. (Specific numerical results not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices or tests) used for the mechanical testing. "Mechanical testing was performed" is a general statement.
- Data Provenance: The data is from mechanical testing performed on the device components (compression staple and non-locking cortical screw). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the human clinical sense. The testing would have been conducted by the manufacturer or a contracted lab.
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 study described is mechanical performance testing of a medical device, not a human clinical study requiring expert assessment of ground truth. The "ground truth" here is compliance with established mechanical engineering standards.
4. Adjudication Method for the Test Set
This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are used for clinical studies where multiple experts interpret data to establish a consensus ground truth. For mechanical testing, adherence to a standard protocol and measurement accuracy are the primary concerns.
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 information is not applicable. The device described is a physical orthopedic fixation system (staple and screws), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance testing was established mechanical engineering standards:
- ASTM F-564 for the compression staple.
- ASTM F-543 for the non-locking cortical screw.
The device's performance was evaluated against the requirements and methodologies outlined in these recognized standards.
8. The Sample Size for the Training Set
This is not applicable as the testing described is mechanical performance evaluation of a medical device, not the training of an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this mechanical performance study.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.