(145 days)
The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.
The DePuy Synthes Static Staple is an implant for bone fixation designed for extra-articular closing wedge osteotomies of the 1st ray of the forefoot. The implant is offered in two (2) configurations of 26° and 90° to address varying patient anatomy of the foot, particularly the 1st ray of the forefoot. The Static Staple implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld inserter along with drill guide and K-wires.
This appears to be a 510(k) premarket notification for a medical device, specifically the DePuy Synthes Static Staples. For such medical devices, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, rather than diagnostic accuracy or clinical outcomes as might be found for AI/imaging devices.
Based on the provided document, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific "reported device performance" values in a pass/fail format. However, it states that the following non-clinical performance analysis were conducted and implies that the device met acceptable standards as substantial equivalence was claimed:
| Test/Analysis | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Bend (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate device integrity under static loading. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| Dynamic Bending (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate device fatigue resistance under cyclic loading. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| Pull-out testing (according to ASTM F564) | Meet or exceed predicate device performance; demonstrate secure fixation in bone. | (Not explicitly quantified in this summary, but the submission claims substantial equivalence, implying acceptable performance) |
| MRI Conditional Testing | Establish MR Conditional parameters (e.g., safe magnetic field strength, SAR, temperature rise, image artifacts). | (Not explicitly detailed, but this testing was conducted to establish safe MR Conditional parameters.) |
| Technological Characteristics Comparison | Equivalent to predicate devices in performance, basic design, material, and sizes. | Declared equivalent to predicate devices (K931155) in these aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as this is not a study focused on a diagnostic algorithm but rather a mechanical device. The "test set" here refers to the physical staples subjected to mechanical testing. The exact number of staples tested for each non-clinical analysis is not specified in this summary.
- Data Provenance: The studies were non-clinical (mechanical testing, MRI conditional testing). The location where these tests were performed is not specified, but the sponsor is DePuy Synthes, located in West Chester, PA, USA. The data is retrospective in the sense that the tests were performed on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology in AI/imaging studies. For this mechanical device, the "ground truth" for the tests are the established standards (ASTM F564) and the physical properties of the materials and design. The testing would be performed by engineers and technicians, not clinical experts, and the results interpreted against defined specifications.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication by experts. The results of the mechanical tests are quantitative measurements compared against established standards or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a bone fixation staple. The document explicitly states: "Clinical testing 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 a bone fixation staple, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data (mechanical testing and MRI conditional testing) is based on established engineering standards (e.g., ASTM F564) and material science principles, aiming to demonstrate the physical integrity and functional safety of the device. For substantial equivalence, the "ground truth" for comparison is the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.