(19 days)
The subject orthopedic wires are single-use devices. Like the predicate devices, they are intended for:
- Bone fracture fixation,
- Osteotomy,
- Arthrodesis,
- Correction of deformity,
- Revision procedures where other treatments or devices have been unsuccessful, and;
- Bone reconstruction procedures.
The subject devices are also cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube (6 per tube), or as a 24" length, or as a 72" (6 Foot) coil. The subject devices are 0.0126", 0.0159", 0.020", 0.040" and 0.046" in diameter.
The provided document is a 510(k) Premarket Notification for a line extension to an Orthopedic Wire. It explicitly states: "No testing was performed to demonstrate the equivalence of the subject devices."
Therefore, based on the provided text, the device did not undergo any specific study to prove it meets acceptance criteria. Instead, its clearance was based on demonstrating substantial equivalence to a legally marketed predicate device, without new performance testing.
Given this, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., tensile strength, flexibility limits) for the new wire sizes. The acceptance was based on substantial equivalence to the predicate device.
- Reported Device Performance: Not performed or reported. The submission states, "No testing was performed to demonstrate the equivalence of the subject devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable as no new testing was performed.
- Data Provenance: Not applicable.
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 as no new testing or ground truth establishment was performed for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new testing or adjudication for performance was performed.
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
- Not applicable. This is not an AI-assisted device. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable, as no new performance data was generated for the subject device. The clearance relies on the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
- Not applicable as this is not a machine learning/AI device.
Summary of the document's approach:
The manufacturer pursued a "Special 510(k) Premarket Notification" for a line extension. This pathway is typically used when the modification to a legally marketed device does not raise new questions of safety and effectiveness. In this instance, the "line extension" involved new diameters of existing cobalt chromium alloy orthopedic wires. The core argument for substantial equivalence was likely based on:
- The identical material (cobalt chromium alloy).
- The identical intended use.
- Presumably, the new wire sizes falling within a range that would not significantly alter the established mechanical properties or biological compatibility compared to the predicate devices, despite the lack of new testing. The FDA concurrence letter confirms that they found the device "substantially equivalent" for the stated indications.
§ 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.