(58 days)
The DIP implants are indicated for distal interphalangeal joint fusion of the long fingers. Treatment may include complementary immobilization of the finger (e.g. splint) if considered preferable by the surgeon.
The Distal InterPhalangeal (DIP) Arthrodesis System, is composed of intramedullary implant, designed to act as a bone fastener for distal interphalangeal arthrodesis of the long fingers. The implant is composed of 2 parts implanted in the proximal and distal phalanx and locked together in a rigid arthrodesis system.
Sizes: The DIP Arthrodesis System is composed of implants available in different lengths and angles. The proximal implant is available in two sizes. The distal implant is available in 2 sizes combined with two angles of plantar flexion: 0 degree or 15 degrees to accommodate the size variation of the phalanges across the patient population and interphalangeal angles.
Material: The DIP Arthrodesis System is manufactured from PEEK-OPTIMA® (PolyEtherEtherKetone) polymer from Invibio® as per ASTM F2026, a radiolucent material.
Single use: The DIP Arthrodesis System is designed for single use only.
Sterilization: The DIP Arthrodesis System is supplied sterile, using gamma irradiation.
This is a 510(k) premarket notification for a medical device called the "DIP Arthrodesis System". It's a bone fixation fastener used for distal interphalangeal joint fusion of the long fingers.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Bench Testing | Met acceptance criteria. |
| * Static bending tests | The DIP Arthrodesis System was compared to a predicate device (Tornier StayFuse and others). The results indicated that the DIP Arthrodesis System met the acceptance criteria for static bending. (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| * Dynamic bending tests | The DIP Arthrodesis System was compared to a predicate device. The results indicated that the DIP Arthrodesis System met the acceptance criteria for dynamic bending. (Specific numerical values for acceptance criteria or performance are not provided in this summary.) |
| Pyrogen Testing | Met pyrogen limit specification. |
| * Limulus Amebocyte Lysate (LAL) test | The device was tested using the LAL test in accordance with ANSI/AAMI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring and alternative to batch testing. This method determined that the device meets the pyrogen limit specification. (Specific pyrogen limit or test results are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the mechanical bench testing. It only states that the testing was performed on the "DIP Arthrodesis System compared to predicate device." This implies a comparative study, but the number of devices tested for each condition (test device vs. predicate) is not detailed.
The data provenance is not explicitly mentioned (e.g., country of origin). However, given that it's a bench test for device performance, the "data provenance" would refer to the testing facility and the conditions under which the tests were run. The summary states it was performed by an "independent test laboratory."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable for this type of device and study. The "ground truth" for mechanical bench testing is established by engineering standards and specifications (e.g., ASTM standards for material properties, specified load limits, fatigue cycles). It does not involve human expert interpretation of clinical data in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretations. Mechanical bench testing relies on objective measurements and established engineering protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices, often involving human readers interpreting medical images with and without AI assistance. This device is a bone fixation fastener, and its evaluation is based on mechanical performance and biocompatibility, not diagnostic accuracy.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in a sense, a standalone evaluaton was done. The mechanical bench testing and pyrogen testing are evaluations of the device itself (standalone performance) against predefined engineering and safety standards, without human intervention in the device's function during the test. There is no "algorithm" in the context of this mechanical device.
7. The Type of Ground Truth Used:
The ground truth used for this device's evaluation consists of:
- Engineering Standards and Specifications: For mechanical bench testing, the ground truth is established by accepted engineering principles for bone fixation devices, performance characteristics of the PEEK-OPTIMA® material (ASTM F2026), and comparison against the performance of legally marketed predicate devices. The acceptance criteria would be derived from these standards and the performance of the predicates.
- Regulatory Standards: For pyrogen testing, the ground truth is defined by regulatory standards such as ANSI/AAMI ST72:2011, which specifies acceptable limits for bacterial endotoxins.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to develop and train machine learning algorithms. This device is a physical, mechanical implant and does not involve AI or machine learning algorithms. Therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
§ 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.