(106 days)
The Arthrex Blunt Tip Screws are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used in conjunction with FiberTape, they can be used to treat patella fractures.
The Arthrex FiberTape suture products are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries. When used in conjunction with the Arthrex Blunt Tip Screws, Fiber Tape can be used to treat patella fractures.
The Arthrex Blunt Tip Screws with FiberTape is a construct that includes stainless steel, blunt tip, partially threaded, cannulated low profile screws and FiberTape.
The provided document is a 510(k) premarket notification for a medical device called "Arthrex Blunt Tip Screws with FiberTape." This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Unfortunately, this document does not contain the detailed information required to fill out all parts of your request regarding acceptance criteria and a study proving device performance.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device is "substantially equivalent" to predicate devices based on "Geometrical analysis" and "the summary of data submitted." It does not provide a table with specific performance acceptance criteria (e.g., tensile strength thresholds, bending stiffness limits) or detailed reported device performance values for these criteria.
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| No specific criteria or performance values provided in text. | No specific criteria or performance values provided in text. |
| (Hypothetical: Tensile Strength > 100N) | (Hypothetical: 120N) |
| (Hypothetical: Fatigue Life > 1,000,000 cycles) | (Hypothetical: 1,500,000 cycles) |
2. Sample size used for the test set and data provenance:
The document mentions "Geometrical analysis" and a "summary of data submitted" but does not specify numerical sample sizes for any test sets. It also does not discuss data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable to this type of submission. This document pertains to mechanical properties and substantial equivalence, not clinical diagnostic performance or expert consensus on a test set.
4. Adjudication method for the test set:
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is a medical device for internal bone fixation and soft tissue approximation, not a diagnostic imaging device typically evaluated with MRMC studies.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used:
The "ground truth" in this context is the performance of the legally marketed predicate devices. The submission implies that the Arthrex Blunt Tip Screws with FiberTape either meet or exceed the performance of these predicates, or that any differences do not raise new questions of safety or effectiveness. The methods used to establish this "ground truth" for the predicate devices would have been their own clearance processes, likely involving mechanical testing and potentially clinical data.
8. Sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is present in the document relevant to your query:
- Device: Arthrex Blunt Tip Screws with FiberTape
- Purpose of Submission: To obtain clearance for the device for internal bone fixation for bone fractures in the patella.
- Method for demonstrating equivalence: "Geometrical analysis" and "summary of data submitted" demonstrate substantial equivalence to predicate devices.
- Predicate Devices:
Conclusion Regarding your Request:
The provided 510(k) clearance letter and summary confirm the FDA's determination of substantial equivalence for the Arthrex Blunt Tip Screws with FiberTape to predicate devices. However, it does not contain the detailed study results, specific acceptance criteria, sample sizes, or expert involvement data that you requested. These details would typically be found in the manufacturer's internal test reports or the full 510(k) submission, portions of which are not public in this summary document. The document emphasizes mechanical and design equivalence rather than diagnostic performance assessed by human readers or algorithms.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.