(63 days)
The Vilex X-Fix is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear & Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "Ultima HA Coated Half Pins And Wire" manufactured by Vilex in Tennessee, Inc. It details the substantial equivalence review process, but it DOES NOT contain information about specific acceptance criteria, a study that proves the device meets those criteria, or performance metrics.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Ultima HA Coated Half Pins and Wires by Vilex, K132820). The rationale for substantial equivalence is based on:
- Indications for Use: The current device has the same intended uses as the predicate.
- Technological Characteristics: The device has similar technological characteristics (e.g., material, sizes, design) to the predicate.
- Material of Construction: The materials used are the same.
- Analysis Data: General analysis data is mentioned as supporting safety and effectiveness.
Therefore, I cannot provide the requested information about acceptance criteria and device performance as it is not present in the provided text.
Based on the provided text, I can only provide the following:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics. It establishes substantial equivalence by comparing the device's characteristics and indications for use to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No specific test set, sample size, or data provenance is mentioned for performance evaluation in this 510(k) summary. The document relies on similarity to a predicate device and material/analysis data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment related to a test set for performance evaluation is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method is mentioned.
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 device is a medical implant (bone fixation fastener), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available/Not Applicable. The concept of "ground truth" as it applies to performance evaluation of a diagnostic or AI device is not relevant here. The substantial equivalence relies on demonstrating that the device is as safe and effective as a legally marketed predicate through design, material, and intended use similarities.
8. The sample size for the training set
- Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth for it is relevant to this device.
Summary of what is available from the document:
- Device Name: Ultima HA Coated Half Pins and Wires
- Predicate Device: Ultima HA Coated Half Pins and Wires by Vilex (K132820)
- Basis for Substantial Equivalence: Similar indications for use, technological characteristics (materials, sizes, design), and general analysis data.
- Indications for Use:
- Stabilization of Fractures & Osteotomy
- Rear & Mid-foot Foot Arthrodesis
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
- Material: Medical grade stainless steel coated with Hydroxyapatite (HA).
- Safety Testing: Pyrogen testing was conducted and confirmed the device is non-pyrogenic.
§ 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.