(154 days)
The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
The Nextra® CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Nextra® CH Cannulated Hammertoe System." It is not a document assessing the performance of an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, human reader performance, AI standalone performance, and ground truth establishment is not present in this text.
The document focuses on demonstrating substantial equivalence of the new device to a legally marketed predicate device (K213530). This process typically relies on comparing indications for use, technological characteristics (materials, design, sizes, mechanical properties), and performance data (often non-clinical) to show that the new device is as safe and effective as the predicate.
Here's a breakdown of what can be extracted from the document, and what cannot:
What is present in the document:
- Device Name: Nextra® CH Cannulated Hammertoe System
- Indicated Use: Small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.
- Predicate Device: Nextra® CH Cannulated Hammertoe System (K213530)
- Basis for SE: "There are no differences between the subject device system and the predicate device systems. The Nextra CH Cannulated Hammertoe system is substantially equivalent to the predicate device regarding the intended use and indications, material, design, sizes, and mechanical properties."
- Non-Clinical Testing Mentioned:
- Endotoxin testing (Limulus Amebocyte Lysate (LAL) method) - Results met the Endotoxin limit of ≤20 EU per device.
- Clinically representative cadaver study: "evaluated by varying levels of surgeon proficiency is confirmed to produce repeating successful outcomes with equal or greater fixation compared to the standard of care." (No specific sample size or detailed outcomes provided).
- Verification bench test: "evaluate implant assembly/disassembly force... results demonstrated the average assembly force of the implants threaded into bone foam by the subject device driver is greater than the average assembly force of implants threaded into bone foam by the predicate driver." (No specific quantitative acceptance criteria or results beyond "greater than" provided).
- Absence of Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the Nextra CH Cannulated Hammertoe System to the predicate device."
What is NOT present in the document (and therefore cannot be answered from the provided text):
- A table of acceptance criteria and the reported device performance (in the context of AI/ML evaluation): The document refers to "acceptance criteria" only implicitly through "meeting the Endotoxin limit" and "greater than" for assembly force, but these are not specific quantitative values for a device performance study in the way you've outlined for an AI/ML system. There are no detailed tables of performance metrics.
- Sample size used for the test set and the data provenance: While a "clinically representative cadaver study with statistically relevant sample size" is mentioned, the specific sample size is not disclosed. Data provenance (country, retrospective/prospective) is also not stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant here. The cadaver study involved "varying levels of surgeon proficiency," but not for establishing ground truth as you've defined it.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a physical medical implant, not an AI/ML diagnostic system.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML system's evaluation. For the cadaver study, "successful outcomes" and "fixation" were evaluated, but the method for establishing "ground truth" (e.g., a definitive measure of fusion success) for that study is not detailed here.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided text is an FDA 510(k) clearance letter and summary for a physical orthopedic implant. It does not contain the information requested about the evaluation of an AI/ML medical 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.