(98 days)
DynaBridge is indicated for:
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy.
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis of the hand, foot, and bone appropriate for the size of the device. The implant is offered in a range of sizes to address a variety of indications and patient anatomy with bridge sizes from 9mm to 25mm. The system is offered sterile and non-sterile.
This is a 510(k) summary for a medical device called DynaBridge, which is a bone staple. 510(k) summaries are for demonstrating substantial equivalence to a predicate device, not for providing detailed clinical efficacy data. Therefore, the information you are looking for regarding acceptance criteria and detailed study results to prove device performance for an AI/ML device is not present in this document.
Here's why and what information can be extracted:
- This is not an AI/ML device: The description identifies it as a "Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis." This is a physical orthopedic implant, not a software or AI/ML diagnostic/therapeutic device. Therefore, the concepts of "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," or "standalone performance" for an algorithm simply do not apply here.
- "Acceptance Criteria" for this device type: For a bone staple, acceptance criteria would typically involve engineering performance specifications and biocompatibility, not AI performance. The document lists "Non-clinical Test Summary" which implies performance testing such as "Static Four-Point Bend Test," "Dynamic Four-Point Bend Test," "Pull-out Test," "Corrosion Test," "AI Temperature Test" (likely a typo and meant to be "Atmospheric Temperature Test" or similar), and "Pyrogenicity" testing. The acceptance criteria for these tests would be defined in standards (e.g., ASTM standards referenced for materials) or internal specifications, and the reported performance would be that the device "meets the recommended maximum endotoxin level" and that "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
- No Clinical Studies: The document explicitly states: "No clinical studies were performed." This further confirms that this submission relies on engineering and biocompatibility testing to demonstrate substantial equivalence, rather than clinical efficacy studies.
Given the nature of the device and the content of the 510(k) summary, I cannot populate the table or answer most of your detailed questions regarding AI/ML device performance or study design.
Here is the information directly extracted or inferred from the provided text, aligning with the type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferrred from Non-clinical Test Summary) | Reported Device Performance |
|---|---|
| Mechanical Strength/Durability (Static Four-Point Bend) | "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices." (Specific quantitative values not provided in this summary, but implied to meet an equivalence standard). |
| Mechanical Strength/Durability (Dynamic Four-Point Bend) | "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices." |
| Mechanical Fixation (Pull-out Test) | "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices." |
| Corrosion Resistance | "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices." |
| Biocompatibility (Pyrogenicity) | "The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device." |
| Material Properties (Nitinol, Stainless Steel, Aluminum) | Conforms to specified ASTM standards (ASTM F-2063, ASTM F899, ASTM B209). Implicitly, this means the materials meet the chemical and mechanical properties defined by these standards. |
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" would refer to physical devices or materials tested in non-clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would relate to accurate measurements against engineering standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. No clinical studies were performed, and it's not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. Not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, ground truth would be established by physical measurements and adherence to recognized engineering standards (e.g., ASTM) and biocompatibility limits.
- The sample size for the training set: Not applicable. No AI/ML model.
- How the ground truth for the training set was established: Not applicable. No AI/ML model.
§ 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.