(330 days)
The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.
The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.
The Vilex cannulated metallic hemi implant is intended for single use only.
Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to resurface the base of the proximal phalanx. It is similar in design to the predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of articular surface shape and fixation. Implants will be offered in cobalt chrome or titanium, with or without Hydroxyapatite (HA) coated stem and back as an option.
The provided text is a 510(k) summary for a medical device (Vilex Cannulated Metallic Hemi Implant). It describes the device, its indications for use, and a claim of substantial equivalence to predicate devices. However, it does not include the detailed performance study information requested in the prompt.
Specifically, the document states: "Non-Clinical Test Data: Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity and resistance to bending torques." This indicates that the primary evidence for this device's acceptance is based on engineering analysis and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics, ground truth establishment, or human reader involvement.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
Acceptance Criteria and Device Performance Study for Vilex Cannulated Metallic Hemi Implant
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Integrity: The device must demonstrate mechanical integrity equivalent to predicate devices. | Equivalent: "Based on the engineering analysis, the Vilex implants are equivalent to predicates in terms of mechanical integrity..." |
| Resistance to Bending Torques: The device must demonstrate resistance to bending torques equivalent to predicate devices. | Equivalent: "...and resistance to bending torques." |
| Indications for Use: The device's indications for use must be comparable to legally marketed devices. | Comparable: "The methods used to establish equivalence are comparisons of indications for use..." |
| Materials of Construction: The device's materials must be comparable to legally marketed devices. | Comparable: "...materials of construction..." |
| Sizes: The device's sizes must be comparable to legally marketed devices. | Comparable: "...sizes..." |
| Shapes: The device's shapes must be comparable to legally marketed devices. | Comparable: "...and shapes..." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This device's acceptance is based on an "engineering analysis" and comparison to predicate devices, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was an engineering analysis.
4. Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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:
- No. This is a medical implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a medical implant, not an algorithm.
7. The type of ground truth used:
- Engineering Analysis/Predicate Device Specifications: The "ground truth" for the device's acceptance is based on its engineering properties matching those of previously approved predicate devices, along with comparable indications for use, materials, sizes, and shapes.
8. The sample size for the training set:
- Not applicable. This device's acceptance is based on engineering comparison, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for a machine learning model is involved.
Summary:
The provided 510(k) summary for the Vilex Cannulated Metallic Hemi Implant demonstrates substantial equivalence through an engineering analysis and comparison to predicate devices in terms of mechanical integrity, resistance to bending torques, indications for use, materials, sizes, and shapes. This is a common pathway for medical device clearance, especially for devices similar to existing ones. It does not involve clinical studies with patient data, expert ground truth, or AI-related performance metrics.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.