(85 days)
OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.
The OsteoBullet Compression Screw has a wide range of diameters and lengths for use in a variety of fracture treatments. Implants are available as cannulated or non-cannulated and made from Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants are provided sterile and are for single use only. The system includes instrumentation to aid in delivery of the implants including drill guides, guide wires, depth gauge, manual drills, manual stop drills, taps, and drivers.
Below is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Axial Pushout Performance (per ASTM F543-13) | Confirmed that the Subject device performed as intended and is at least equivalent to the predicate devices. |
| Torque to Failure (per ASTM F543-13) | Confirmed that the Subject device performed as intended and is at least equivalent to the predicate devices. |
| Static 3-point Bending (per ASTM F1264-14) | Further confirmed the performance and substantial equivalence of the Subject device. |
| Dynamic 3-point Bending (per ASTM F1264-14) | Further confirmed the performance and substantial equivalence of the Subject device. |
| No new risks compared to predicates | Documentation was provided to demonstrate that the Subject device poses no new risks when compared to the predicate and reference devices. The Subject device is identical to the predicate devices in intended use and similar regarding indications for use, materials, technological characteristics, and labeling. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes (number of screws or tests) used for the performance testing. The data provenance is described as "Documentation was provided" and relates to in vitro mechanical testing of the device itself, rather than human data. There is no mention of country of origin for the data or if it was retrospective or prospective, as these are not relevant for this type of mechanical testing.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable. The study described is not a clinical study involving human patients or expert interpretation of medical data. It is a benchtop (mechanical) performance study comparing a new medical device (OsteoBullet Compression Screw) to existing predicate devices based on objective engineering standards (ASTM F543-13 and ASTM F1264-14). Therefore, there is no "ground truth" to be established by experts in the context of diagnostic accuracy or treatment outcomes.
4. Adjudication Method:
This section is not applicable for the same reasons as point 3. Benchtop mechanical testing does not involve adjudication.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging devices with human readers. The document describes mechanical performance testing of a physical implant (bone screw).
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. The device is a physical bone fixation screw, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study is defined by established engineering standards and specifications for mechanical performance of bone fixation fasteners (ASTM F543-13 and ASTM F1264-14), and the performance characteristics of the legally marketed predicate devices. The performance metrics (e.g., axial pushout, torque to failure, bending strength) are quantitatively measured according to these standards.
8. Sample Size for the Training Set:
This section is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How Ground Truth for the Training Set was Established:
This section is not applicable for the same reasons as point 8.
§ 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.