(46 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 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 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 provided text describes a 510(k) premarket notification for a medical device, specifically the ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology. This document is a regulatory submission to the FDA seeking clearance for a device based on its substantial equivalence to a legally marketed predicate device.
It's important to understand that a 510(k) summary focuses on demonstrating substantial equivalence primarily through non-clinical performance data (e.g., mechanical testing, material properties) when changes are minor and do not significantly alter the device's fundamental technology or intended use. Clinical studies are often waived when substantial equivalence can be shown through other means.
Therefore, the information you're requesting regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device's performance study (e.g., sensitivity, specificity, MRMC studies, expert ground truth) is not applicable to this specific document. This document pertains to a mechanical orthopedic implant and its regulatory clearance based on engineering and material performance.
Here's why and what information is available:
This document describes the regulatory clearance of a mechanical orthopedic implant, not an AI/ML diagnostic device. The "acceptance criteria" and "study" described in the document are focused on the mechanical and material performance of the implant, demonstrating its equivalence to a predicate device.
Key Points from the Document Regarding "Acceptance Criteria" and "Study":
- Device Type: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology (a knee replacement component).
- Purpose of Submission: Update Tensile Mechanical Properties In-Process Limits. This indicates a minor change related to manufacturing specifications, not a fundamental change in design or function.
- Demonstration of Equivalence: The document states that the subject device is "identical to the predicate... in principle of operation, intended use, classification, design, materials and fixation."
- Performance Data: The only "performance data" mentioned is "Tensile Testing." In addition, the device is stated to "continue to meet the requirement of bacterial endotoxin testing as specified in ASNI/AAMI ST 72:2019."
- Clinical Testing: The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."
- Ground Truth: For a metallic implant, "ground truth" would relate to material properties, mechanical strength, biocompatibility, and long-term in-vivo performance, established through standardized testing, material specifications, and potentially animal/cadaver studies, rather than subjective expert interpretation of medical images.
- No AI/ML Component: There is no mention of an AI/machine learning component to this medical device.
If we were to interpret your request in the context of this specific regulatory submission for a mechanical device, here's how some of your points would be addressed, with the understanding that they don't map directly to AI/ML study methodologies:
1. A table of acceptance criteria and the reported device performance
The document does not provide a detailed table of acceptance criteria for mechanical properties, nor specific reported performance values the way an AI/ML study would. It states that "Tensile Testing" was performed and that the device "continues to meet the requirement of bacterial endotoxin testing." For a 510(k) submission concerning a minor change, the full detailed test reports are typically kept on file by the manufacturer and are part of the full 510(k) submission, not necessarily summarized in detail in the publicly available 510(k) summary.
General "Acceptance Criteria" inferred:
| Acceptance Criteria (Inferred for this type of device) | Reported Device Performance (as stated in document) |
|---|---|
| Tensile Mechanical Properties Limits | Met/Continue to meet |
| Bacterial Endotoxin Limits (ASNI/AAMI ST 72:2019) | Met/Continue to meet |
| Substantial Equivalence to Predicate | Achieved |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the summary document. For mechanical testing, this would refer to the number of test coupons or actual devices subjected to tensile testing.
- Data Provenance: Not specified. Testing would typically be conducted by the manufacturer or a certified testing laboratory. The device's origin is Ireland, based on the submitter information, but testing could happen anywhere globally. The document is silent on whether it's retrospective or prospective data, but laboratory mechanical testing is generally conducted prospectively for regulatory submissions.
3. Number of experts used to establish the ground truth and qualifications
- Not applicable in the AI/ML sense. For a mechanical device, "ground truth" is established by engineering standards, material specifications (e.g., ASTM F-136 for Titanium Alloy), and quantitative mechanical property measurements. There are no radiologists or other clinical experts adjudicating images for ground truth in this context.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations (like image reads). Mechanical testing involves objective measurements against predefined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No. This type of study is for evaluating human performance, often with AI assistance, in diagnostic tasks. It is not relevant to the clearance of a mechanical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This relates to AI algorithm performance. There is no AI algorithm in this device.
7. The type of ground truth used
- Engineering Specifications and Material Standards: The ground truth for this device would be established by validated mechanical testing methods (e.g., ASTM standards for tensile strength, fatigue, material composition) and biological safety (e.g., bacterial endotoxin limits, biocompatibility as per ISO standards not explicitly mentioned but implied for implantable devices). This is an objective, quantitative ground truth.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
In summary, the provided document is a regulatory communication for a mechanical orthopedic implant, not an AI/ML-driven device. Therefore, the detailed criteria and study structures relevant to AI/ML performance evaluation (like those involving expert interpretation, MRMC, sensitivity/specificity, etc.) are entirely outside the scope of this particular submission.
§ 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.