(90 days)
The dynaMXTM Tabbed Staple is indicated for:
· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,
· Fixation of proximal tibial metaphysis osteotomy.
The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.
- The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.
The provided text is a 510(k) Summary for the dynaMX™ Tabbed Staple, a medical device for bone fixation. It does NOT describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI performance metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device.
The document focuses on the substantial equivalence of the dynaMX™ Tabbed Staple to predicate devices based on bench testing (laboratory studies), not AI model performance.
Here's a breakdown of the relevant information that IS present, to clarify why your specific questions cannot be answered from this text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The document states that "A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging." The implied acceptance criteria are that the device performs comparably to the predicate devices in these bench tests.
- Reported Device Performance: The document lists the types of tests performed:
- Elastic Static Bending Testing
- Bending Fatigue Testing
- Staple Pull-Out Force
- Corrosion Testing
- Package Seal Strength Verification
- Transformation Temperature Determination
- However, it does not provide the numerical results or specific acceptance thresholds for these tests. It only states that these studies were conducted to support substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No information on sample size or data provenance is provided as these were bench tests, not clinical studies in humans.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This was a bench test involving physical device properties, not clinical assessment requiring expert interpretation to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was a bench test, not a clinical trial requiring adjudication of clinical findings.
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:
- No MRMC study was done, and no AI component is described. This device is a physical bone fixation staple.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for a physical device in bench testing is typically the actual physical properties measured against engineering specifications or predicate device performance.
8. The sample size for the training set:
- Not applicable. This device does not use a training set as it is not an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.
§ 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.