(99 days)
The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE™ Total Knee Replacement System. Porous coated implants may be used with or without cement. Candidates for total knee replacement include patients with a severely painful and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant (provided that adequate bone is present).
The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The FDA document provided is a 510(k) Premarket Notification clearance letter for a medical device: "ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology."
This document does not describe a study involving a medical device using Artificial Intelligence (AI). Instead, it concerns a physical orthopedic implant (a knee replacement component) and its substantial equivalence to previously cleared devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical, material, and chemical properties of the physical implant, and the tests performed to demonstrate their equivalence to a predicate device.
Therefore, I cannot provide information for the following points from your request as they are relevant only to AI/software-based medical devices, which this document does not cover:
- Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
However, I can extract information relevant to the physical device's acceptance criteria and the studies performed to demonstrate its substantial equivalence.
Here's what I can glean from the provided document regarding the physical device:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of explicit numerical acceptance criteria for performance or a direct comparison to specific reported values for the new device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. The primary difference highlighted is the material grade.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Material Composition Equivalence: The new device should have material properties comparable to the predicate device, particularly regarding the Titanium alloy. | The subject device uses Titanium alloy (Ti-6A1-4V) with Grade 5 chemistry (ASTM F-2924). The predicate devices use Titanium alloy with Grade 23 chemistry (ASTM F-3001). The document implies that despite this grade difference, the devices are equivalent based on testing. |
| Manufacturing Process Consistency: The manufacturing process (specifically 3DP technology) should yield consistent and acceptable material properties. | Oxygen Content Study was performed. This suggests an acceptance criterion related to maintaining low oxygen levels in the porous structure, which is critical for material integrity and biocompatibility. (Specific values are not provided in the document). |
| Material Recycling Suitability: If material is recycled in the 3DP process, it must not compromise the final product's quality. | EOS M290 3D Printer Recycling Study was performed. This suggests an acceptance criterion related to the quality and consistency of parts produced using recycled material from the 3D printing process. (Specific findings are not provided in the document). |
| Biocompatibility & Safety: The material and design should be biocompatible and safe for implantation. | The product code "MBH" (Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis) falls under Class II Special Controls, implying that the device must meet recognized standards for biocompatibility, sterility, mechanical performance, fatigue, and wear, among others. The testing performed (Oxygen Content Study, Recycling Study) supports safety and effectiveness. The document states "Clinical testing was not required to demonstrate substantial equivalence," meaning non-clinical (bench) tests were sufficient. |
| Functional Equivalence: The device should perform equivalently to the predicate in its intended function (e.g., stability, fixation). | The subject and predicate devices are stated to be "the same as... in principle of operation, intended use, classification, design, raw material, and fixation." The AFFIXIUM™ 3DP Technology printed titanium porous structure for biological fixation is utilized by both, supporting functional equivalence in bone ingrowth. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of device. The tests mentioned (Oxygen Content Study, Recycling Study) are laboratory-based material and process characterization studies, not clinical trials with human patient data. Sample sizes would refer to the number of test coupons or components manufactured and tested, which is not specified in this summary.
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. This is not an AI/clinical interpretation study. "Ground truth" in this context would refer to established material and mechanical standards, and the experts would be material scientists, engineers, and quality control personnel involved in the testing, not clinical "experts" establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical interpretations.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for material and manufacturing quality would be established by:
- International standards: Such as ASTM F-2924 and ASTM F-3001 for Titanium alloy chemistry, and other standards for mechanical properties (e.g., fatigue strength, tensile strength).
- Internal specifications and validation methodologies: Defined by the manufacturer based on engineering principles and regulatory requirements.
- Analytical chemistry and material characterization techniques: To determine oxygen content, microstructure, etc.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.