(95 days)
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
The document describes a 510(k) premarket notification for the "Nexis® osteosynthesis snap-off screws" device, comparing it to a predicate device, the "Memometal Fixos screws." This type of submission relies on demonstrating substantial equivalence to a legally marketed device rather than conducting extensive new clinical trials. Therefore, the information provided does not align with the typical structure of acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
However, I can extract and structure the available information regarding the "performance data" that NOVASTEP provided to demonstrate substantial equivalence, framing it in terms of "acceptance criteria" and "reported device performance" as much as possible for this specific type of device (an orthopedic screw).
Acceptance Criteria and Reported Device Performance for Nexis® osteosynthesis snap-off screws
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Based on comparison to predicate and recognized standards) | Reported Device Performance (Summary from 510(k) submission) |
|---|---|
| Material Composition | Similar material: Titanium (Alloy Ti-6Al-4V ELI), in accordance with ISO 5832-3 (Implants For Surgery -- Metallic Materials -- Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy). |
| Mechanical Characteristics | Similar mechanical characteristics to the predicate device (Memometal Fixos screws), specifically mentioning: |
- Driving and removal torque
- Pull-out strength
- Torsional resistance |
| Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993) and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA. |
| Design Characteristics | Similar design characteristics to the predicate device. Nexis® screws are described as non-cannulated snap-off screws designed for permanent compression and secure osseous restoration. |
| Intended Use & Indications for Use | Identical intended use: fixing and stabilizing elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The performance data for mechanical testing and biocompatibility study typically involves a certain number of samples for each test, but the specific quantities are not detailed in this summary.
- Data Provenance: Not explicitly stated. These tests are usually conducted in specialized labs.
- Retrospective or Prospective: Not applicable in the context of comparing a new device's material and mechanical properties to a predicate and recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert assessment of data like in AI/ML performance evaluation. The "ground truth" here related to engineering standards and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context refers to established engineering standards (e.g., ISO 5832-3 for material, ASTM F543-13 for mechanical tests, ISO 10993 for biocompatibility) and the known characteristics of the legally marketed predicate device (Memometal Fixos screws). The testing confirms the new device's properties align with these standards and the predicate.
8. The sample size for the training set
- Not applicable. No training set is used for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable. No training set is used for this type of device submission.
Summary Explanation:
The "study" demonstrating the device meets the acceptance criteria is detailed under "Performance data" in the 510(k) summary. It states that NOVASTEP's Nexis® osteosynthesis snap-off screws have been evaluated for biocompatibility according to FDA-recognized ISO 10993 standards and for mechanical characteristics (driving and removal torque, pull-out strength, torsional resistance) to demonstrate similarity with the predicate device, Memometal Fixos screws. The material (Titanium Alloy Ti-6Al-4V ELI) is also stated to be in accordance with ISO 5832-3 and similar to the predicate.
Crucially, the document explicitly states: "Clinical studies were not required for this submission" and "Animal Studies were not required for this submission." This is typical for 510(k) submissions where substantial equivalence is primarily demonstrated through comparison to a predicate device's design, materials, and mechanical performance, and adherence to recognized standards, rather than new human clinical efficacy trials. The "acceptance criteria" are effectively the established standards and the characteristics of the predicate device that the new device must match or be equivalent to.
§ 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.