(161 days)
The ADVANCE® HA Coated Components are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
The ADVANCE® HA Coated Components are for use without bone cement and are single use devices.
The ADVANCE® HA Coated Components are an HA Coated Spiked Tibial Base and an ADVANCE® HA Coated Modular Keel. The design features of the components are described below.
ADVANCE® HA Coated Spiked Tibial Base
- 4 spikes on the distal surface .
- Manufactured from titanium alloy .
- Titanium sintered bead porous coated .
- HA coated ●
ADVANCE® HA Coated Modular Keel - 2 small anterior fins .
- 2 posterior fins .
- Manufactured from titanium alloy .
- HA coated .
The provided text is a 510(k) summary for a medical device called "ADVANCE® HA Coated Spiked Tibial Base and ADVANCE® HA Coated Modular Keel." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting performance from a de novo study.
Therefore, the requested information cannot be fully extracted as such a study was not performed. The document explicitly states:
"The safety and effectiveness of ADVANCE® HA Coated Components are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification."
This means that Wright Medical Technology, Inc. is claiming their device is as safe and effective as devices already on the market, based on similarities in materials, design, and intended use, and supported by various testing (likely mechanical, material characterization, biocompatibility, etc.) rather than a unique clinical study with specific acceptance criteria as you've outlined.
Here's what can be gathered, and why other parts of your request are not applicable:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document does not establish new acceptance criteria as it is a 510(k) submission based on substantial equivalence. Performance is implied to be equivalent to predicate devices. A typical 510(k) submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, pre-defined acceptance criteria in a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human-subject clinical test set, in the sense of a prospective or retrospective study to measure a particular performance metric against acceptance criteria, is described. The "testing results" mentioned in the document likely refer to bench testing (e.g., mechanical properties, material characterization) rather than a clinical dataset.
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. As no clinical test set for algorithmic performance or human assessment is mentioned, there's no ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No human-based test set or adjudication process 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:
- Not Applicable. This device is a knee arthroplasty component (implant), not an AI-assisted diagnostic or assistive device for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (implant), not an algorithm or software-as-a-medical-device (SaMD).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No "ground truth" in the context of diagnostic or algorithmic performance is used. For this type of device, ground truth would typically be related to the device's physical properties (e.g., material strength, wear characteristics, biocompatibility) demonstrated through bench testing and often compared to known values of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, this question is not relevant.
Summary of what we do know from the document (focused on Substantial Equivalence):
- Device Name: ADVANCE® HA Coated Spiked Tibial Base and the ADVANCE® HA Coated Modular Keel
- Intended Use: Knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions like noninflammatory/inflammatory degenerative joint disease, correction of functional deformity, revision procedures, and treatment of fractures. For use without bone cement and are single-use devices.
- Basis of Approval: Substantial Equivalence to previously cleared predicate devices.
- Evidence for Substantial Equivalence: "substantial equivalence information, materials data, and testing results." (Specific details of these tests are not provided in this 510(k) summary, but would be in the full submission).
- Key Features for Substantial Equivalence: Intended use, material, and design features are stated to be substantially equivalent to predicate devices.
- Device Materials:
- ADVANCE® HA Coated Spiked Tibial Base: Manufactured from titanium alloy, titanium sintered bead porous coated, HA coated.
- ADVANCE® HA Coated Modular Keel: Manufactured from titanium alloy, HA coated.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.