Search Results
Found 2 results
510(k) Data Aggregation
(180 days)
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status. These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
The HLS Uni Evolution prosthesis consists of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated to the femoral component: one all polyethylene tibial component and one polyethylene metal-backed tibial component. The present device modification submission consists in the addition of a new femoral component, named U-KneeTec, to the current cleared range. This new component is the distal resection version of the HLS Uni Evolution. The U-KneeTec has been designed to be used in association with the already cleared polyethylene tibial component of HLS Uni Evolution. The U-KneeTec is intended for cemented use only.
The provided text is a summary of safety and effectiveness information for a Special 510(k) Premarket Notification for the HLS Uni Evolution and U-KneeTec Unicompartmental Knee Prosthesis. It is a regulatory document affirming substantial equivalence to predicate devices, and therefore does not include information about acceptance criteria, device performance studies, sample sizes, or ground truth establishment that would typically be found in a study report for a new device's performance.
The document states:
"Non-clinical testing was not necessary to determine substantial equivalence between the U-KneeTec and the cited predicate devices."
"It has been determined that the proposed new U-KneeTec described in this submission does not induce any new or higher risk compared to the predicate devices."
This means that the device was approved based on its substantial equivalence to existing legally marketed predicate devices, rather than on new performance studies demonstrating its specific acceptance criteria. The "performance" in this context refers to its similarity to already approved devices.
Therefore, the requested information cannot be extracted from this document. If this were a new device requiring a full performance study, the document would contain sections detailing those aspects.
Ask a specific question about this device
(318 days)
The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis. The HLS Uni Evolution prosthesis is intended for cemented use only.
The HLS Uni Evolution prosthesis is intended to replace the medial or lateral compartment of the femoro-tibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis. The HLS Uni Evolution prosthesis of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated with the femoral component, one that is all polyethylene and one that is polyethylene metal-backed. The femoral part is manufactured from cast Cobalt-Chromium alloy according to ISO standard 5832-4. The articulating surface, in contact with the bearing component, is mirror polished and the finished aspect of the part in contact with the bone is fine shotblasted. The all polyethylene tibial component is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The metal backed tibial component is composed of a polyethylene part, made from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2, inserted in a stainless steel metal back that conforms to ISO standard 5832-1.
The provided text is a 510(k) Premarket Notification for a medical device (HLS Uni Evolution prosthesis), not a study report detailing acceptance criteria or device performance in the way a clinical or AI-based diagnostic study would. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory requirement for market clearance.
Therefore, many of the requested categories are not applicable to this type of document. I will fill in what can be inferred or directly stated from the provided text and mark the rest as not applicable (N/A).
Acceptance Criteria and Device Performance Study Details for HLS Uni Evolution Prosthesis
Given that this document is a 510(k) Premarket Notification, it does not present acceptance criteria and performance data in the typical format of a clinical trial or AI device validation study. Instead, it focuses on demonstrating "substantial equivalence" to existing legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating equivalence to predicate devices. The "performance" is primarily described by material composition, dimensions, method of fixation, and indications for use, all of which are aligned with the predicate devices.
| Acceptance Criteria (Demonstration of Equivalence to Predicate Devices) | Reported Device Performance (Characteristics of HLS Uni Evolution Prosthesis) |
|---|---|
| Materials: | |
| - Femoral implant material equivalent to predicate. | - Femoral Implant: Cobalt Chromium alloy (ISO 5832-4), mirror polished articulating surface, fine shotblasted bone contact surface. (Matches predicates like Miller/Gallante, Advance Unicondylar, Link Endo-Model Sled Uni-Knee which use Cobalt Chromium alloy, though Miller/Gallante and Advance use ASTM F 75 as standard). |
| - All poly Tibial implant material equivalent to predicate. | - All Poly Tibial Implant: Ultra-high molecular weight polyethylene (UHMWPE) (ISO 5834-2). (Matches Advance Unicondylar Knee System and Link Endo-Model Sled Uni-Knee; Miller/Gallante does not have an all-poly tibial component listed). |
| - Metal backed component materials equivalent to predicate. | - Metal Backed Tibial Component: UHMWPE (ISO 5834-2) + Stainless steel (ISO 5832-1). (Differs from predicates which use Titanium alloy or Cobalt Chromium alloy for the metal backing, but still considered substantially equivalent). |
| Sizes: | |
| - Comparable sizing options to predicate devices. | - Femoral Implant: 5 sizes in 2 thicknesses (3 & 5 mm). (Comparable, but not identical to predicates which have 7, 4, or 4 sizes). |
| - All poly Tibial implant: Comparable sizing options. | - All Poly Tibial Implant: 5 sizes in 3 thicknesses (9, 11 & 13mm). (Comparable to predicates with varying sizes and thicknesses). |
| - Metal backed component: Comparable sizing options. | - Metal Backed Tibial Component: 5 sizes in 3 thicknesses (9, 11 & 13mm). (Comparable, but not identical to predicates with varying sizes and thicknesses). |
| Method of Fixation: Equivalent to predicate. | - Method of Fixation: Cemented. (Matches all predicate devices). |
| Indications for Use: Equivalent to predicate. | - Indications for Use: Replacement of medial or lateral compartment of femoro-tibial knee joint when only one side is affected, for primary or secondary femoro-tibial arthritis. For cemented use only. (Matches all predicate devices). |
| Sterilization Method: Equivalent to predicate. | - Sterilization Method: Gamma radiation. (Matches Miller/Gallante Precoat Unicompartmental; unknown for other predicates listed). |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. This document is a 510(k) submission and does not describe a clinical study with a test set of patients or data. The "test set" here refers to the characteristics and specifications of the device itself being compared to predicate devices.
- Data Provenance: N/A. No patient or clinical data is provided or analyzed for device performance in this submission. The "data" consists of device specifications and material standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A. No ground truth establishment by experts for a test set is described. The "ground truth" for this regulatory submission is essentially compliance with material standards and design principles consistent with predicate devices, evaluated by Tornier S.A.'s regulatory and quality personnel and subsequently by the FDA.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: N/A. No test set requiring expert adjudication is described in this document.
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
- MRMC Study: N/A. This document is for a knee prosthesis, not an AI-assisted diagnostic device. It does not involve human readers interpreting cases or AI.
- Effect Size: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. This document describes a physical medical implant, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the purposes of this 510(k) submission, the "ground truth" is established by adherence to industry standards (e.g., ISO 5832-4 for Cobalt-Chromium alloy, ISO 5834-2 for UHMWPE), and demonstration of substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. This is a regulatory "ground truth" rather than a clinical one.
8. The sample size for the training set
- Training Set Sample Size: N/A. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A. See above.
Ask a specific question about this device
Page 1 of 1