(328 days)
The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:
- . Beta-bsm (ETEX Corporation)
- CarriGen (ETEX Corporation) .
The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.
The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.
The N-Force Fixation System is a medical device and the provided text describes its 510(k) summary for FDA clearance. The concept of "acceptance criteria" and "device performance" in the context of diagnostic AI or image analysis tools, as suggested by the prompt's structure, does not directly apply to this device. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of intended use, design, function, and materials.
Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert consensus, and reader studies are not applicable to this submission.
Here's an adaptation of the requested table and a summary of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate devices and relevant standards) | Reported Device Performance (N-Force Fixation System) |
|---|---|---|
| Mechanical Performance | Not explicitly stated as numerical criteria in this summary. Implied to meet or exceed relevant standards and performance of predicate devices for: |
- Static three-point bending
- Torsion
- Axial pullout
- Insertion torque
- Extraction torque | "Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices."
Specific tests performed: - Static three-point bending
- Torsion
- Axial pullout
- Insertion torque
- Extraction torque
(No quantitative results or specific pass/fail rates are provided in this summary, but the conclusion of substantial equivalence implies satisfactory performance.) |
| Material Composition | Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 (based on predicate devices) | Made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. |
| Bone Void Filler Delivery Capability | Ability to deliver bone void filler materials (Beta-bsm and CarriGen) comparable to ETEX-recommended instruments. | Additional testing was performed to demonstrate substantial equivalence to ETEX recommended instruments with respect to their ability to deliver bone void filler material. |
| Indications for Use (Substantial Equivalence) | Fixation of bone fractures and bone reconstructions. Delivery of specific bone void fillers. (Based on predicate devices and intended use) | Intended for the fixation of bone fractures and bone reconstructions. Can also be used to deliver Beta-bsm and CarriGen bone void fillers. Concluded to be "substantially equivalent ... with respect to its indications for use". |
| Design & Function (Substantial Equivalence) | Screw system for fracture fixation, fully and partially cannulated, fenestrated. (Based on predicate devices) | Described as a screw system for fracture fixation, including fully and partially cannulated screws. Cannulated and fenestrated to allow use as a delivery system. Concluded to be "substantially equivalent ... with respect to its ... design, function". |
Study Details Based on Provided Information:
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Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The study primarily relies on mechanical testing of the device itself, rather than a "test set" of patient data as understood in AI/imaging studies. It involved various screws and instruments.
- Data provenance: Not specified, but generally refers to laboratory mechanical testing data conducted by or for the manufacturer. It is prospective testing, designed to evaluate the physical properties of the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (surgical screw system) and does not involve subjective assessment of images or data by experts to establish "ground truth" in the way an AI diagnostic device would. Ground truth here relates to the engineering specifications and performance against established standards and predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication of results in the traditional sense. Mechanical tests typically involve standardized procedures and measurements (e.g., force, torque, displacement) which are objective.
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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 a diagnostic AI device or an imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and material standards (e.g., ASTM F136 for titanium alloy) and the mechanical performance of legally marketed predicate devices. The N-Force Fixation System's performance in terms of static three-point bending, torsion, axial pullout, insertion torque, and extraction torque is compared against these benchmarks to establish substantial equivalence.
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The sample size for the training set:
- Not applicable. No training set in the context of machine learning or AI is involved.
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How the ground truth for the training set was established:
- Not applicable. No training set in the context of machine learning or AI is involved.
§ 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.