(81 days)
The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
The Arthrex DynaNite PIP (Hammertoe) Implant is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant has a threaded end and a barbed end. The implant will be offered in 12mm, 14mm and 16 mm lengths, each available in straight and bent configurations. The implant is provided on a handled inserter and is sold as sterile, single-use.
This document is a 510(k) premarket notification for the Arthrex DynaNite® PIP (Hammertoe) Implant. It is a Class II medical device for bone fixation. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Barb Pull-out | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Thread Pull-out | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Static/Fatigue Cantilever Bend | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Insertion Torque/Failure Torque | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Corrosion Resistance | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Barb Compression Force | Not explicitly stated as a comparative acceptance criterion, but tested. | Data not provided in this summary. |
| Transformation Temperature | Not explicitly stated as a comparative acceptance criterion, but tested. | Data not provided in this summary. |
| Bacterial Endotoxins Test (BET) | Meets pyrogen limit specifications as per ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. | Meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Barb Pull-out, Thread Pull-out, etc.). It only mentions that "testing was conducted to demonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performed statistically equivalent to the predicate device cleared under K960385."
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be data generated in support of this 510(k) submission, likely from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device performance tests described (mechanical and biological) are laboratory-based, objective measurements, not subjective evaluations requiring expert interpretation of a "ground truth" like in a diagnostic AI study.
4. Adjudication Method for the Test Set
This information is not applicable. As explained above, the tests are objective laboratory measurements, not assessments that require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the performance of a physical medical implant through mechanical and biological testing. It is not an AI/software device that would typically undergo an MRMC comparative effectiveness study to assess human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document concerns a physical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the mechanical performance tests are the objective measurements obtained from laboratory testing, which are then compared to the performance of the predicate device (K960385). For the Bacterial Endotoxins Test, the "ground truth" is adherence to established biological safety standards and regulations (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14).
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is a physical medical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical implant.
§ 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.