(27 days)
The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware:
- · fracture fixation (open and closed)
- · pseudoarthrosis of long bones
- · limb lengthening (epiphyseal or metaphyseal distraction)
- · joint arthrodesis
- · infected fractures or nonunions
- correction of bony or soft tissue deformities
- · correction of segmental defects.
The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts.
This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long.
The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.
The provided text describes the 510(k) clearance for the DEPUY SYNTHES MAXFRAME AUTOSTRUT System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness for a diagnostic or therapeutic purpose.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (AutoStrut G2 K202810), primarily based on changes to the sterilization method of the Hexapod Struts (from non-sterile to sterile).
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided text. The document explicitly states: "Clinical Performance Data was not necessary for the determination of substantial equivalence."
Here's a breakdown of what is mentioned, which largely pertains to non-clinical performance and a comparison to the predicate device:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics an AI or device output would be measured against. The "acceptance" here relates to demonstrating comparable safety and effectiveness to a predicate device.
- Reported Device Performance: The primary "performance" discussed is that "Bench testing demonstrates that the sterile MaxFrame AutoStrut Hexapod Strut is as safe and effective as its predicate device." This implies the new sterile version performs mechanically equivalent to the predicate, as validated by non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate (K202810) | Bench testing demonstrates equivalence. |
| Packaging maintains sterility and device integrity. | Packaging Validation performed. |
| Sterilization process is effective and safe. | Sterilization Validation performed. |
| Biocompatibility of materials. | Biocompatibility Evaluation performed. |
| Shelf life meets expectations. | Shelf-Life Validation performed. |
2. Sample size used for the test set and data provenance:
- Not applicable as no clinical or diagnostic efficacy study is mentioned for this 510(k) submission. The testing performed was "Non-Clinical Performance Testing," including Mechanical Testing, Shelf-Life Validation, Packaging Validation, Sterilization Validation, and Biocompatibility Evaluation. No specific sample sizes for these tests are provided in the summary, nor is data provenance in terms of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable as no diagnostic or clinical performance study with "ground truth" established by experts is described.
4. Adjudication method for the test set:
- Not applicable for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states, "Clinical Performance Data was not necessary for the determination of substantial equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an external fixation system (hardware), not a diagnostic algorithm. While it has a control system and software (cleared under K202810), this specific submission is only for sterile struts and does not detail a standalone algorithm performance study.
7. The type of ground truth used:
- Not applicable as no clinical or diagnostic performance study requiring ground truth (e.g., pathology, outcomes data) is mentioned. "Ground truth" for the non-clinical tests would be defined by engineering standards and test protocols.
8. The sample size for the training set:
- Not applicable as this is not a machine learning or AI algorithm development study.
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as point 8.
In summary, the provided document focuses on regulatory clearance based on substantial equivalence for a medical device (external fixation system) where the primary change is the sterilization method of a component. It does not contain information about clinical performance trials, diagnostic accuracy studies, or AI algorithm validation against performance acceptance criteria.
§ 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.