(112 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, 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 provided text is a 510(k) summary for a medical device (ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology) and does not describe acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" in this context are related to meeting established performance standards for orthopaedic implants and demonstrating similar characteristics to the predicate devices.
Here's a breakdown of what is provided, framed as closely as possible to your request for acceptance criteria and study information, considering that the primary goal here is substantial equivalence, not a standalone performance study with accuracy metrics.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria in the format typically used for AI/diagnostic device performance (e.g., sensitivity >X%, specificity >Y%). Instead, the "acceptance criteria" are implied by the performance standards for orthopaedic implants to demonstrate substantial equivalence, and "reported device performance" refers to the successful completion of these tests.
| Type of Test/Characteristic | Implied Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device "Performance" (Satisfied) |
|---|---|---|
| Tibial Base | ||
| Tray fatigue testing (ASTM F1800) | Meet standard fatigue requirements for knee implants. | Testing performed; results support substantial equivalence. |
| Peg fatigue testing | Meet standard fatigue requirements for peg fixation. | Testing performed; results support substantial equivalence. |
| Fixation testing | Demonstrate adequate fixation strength. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible (non-toxic, non-irritating, etc.). | Testing performed; results support substantial equivalence. |
| Patella | ||
| Peg fatigue testing | Meet standard fatigue requirements for peg fixation. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible (non-toxic, non-irritating, etc.). | Testing performed; results support substantial equivalence. |
| Coating Characterization | ||
| Static interfacial shear (ASTM F1044) | Meet standard static shear resistance. | Testing performed; results support substantial equivalence. |
| Static interfacial tensile (ASTM F1147) | Meet standard static tensile resistance. | Testing performed; results support substantial equivalence. |
| Interfacial shear fatigue (ASTM F1160) | Meet standard fatigue resistance for interfacial shear. | Testing performed; results support substantial equivalence. |
| Abrasion testing | Demonstrate acceptable abrasion resistance. | Testing performed; results support substantial equivalence. |
| Corrosion analysis (ASTM G5-14) | Demonstrate acceptable corrosion resistance. | Testing performed; results support substantial equivalence. |
| Chemical composition analysis (ASTM E2371, E1409, E1941-10, E1447-09) | Material composition matches specifications. | Testing performed; results support substantial equivalence. |
| Morphological evaluation | Surface morphology meets design specifications for porous coating. | Testing performed; results support substantial equivalence. |
| Biocompatibility testing | Be biocompatible. | Testing performed; results support substantial equivalence. |
| Bacterial Endotoxin Testing (ANSI/AAMI ST 72:2019) | Meet specified bacterial endotoxin limits. | Testing performed; results support substantial equivalence. |
| Technological Characteristics | Similar to predicate devices in principle of operation, intended use, classification, design, materials and fixation. | Detailed comparison provided, concluding similarity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various non-clinical tests. For these tests (fatigue, fixation, biocompatibility, coating characterization, etc.), the sample sizes are not explicitly stated in this summary. It is typical for these types of engineering tests to involve controlled laboratory specimens rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable here as these are laboratory tests, not clinical studies.
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)
This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI performance studies rather than the engineering and material performance tests described for this knee implant. The "ground truth" for these tests is established by the specifications and acceptance criteria of the ASTM and ANSI/AAMI standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to a method used to resolve discrepancies in expert interpretation, which is not relevant for the non-clinical, objective engineering tests 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 is a knee implant, not an AI diagnostic device. No human-in-the-loop performance or MRMC studies were conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is related to AI/diagnostic algorithms, not a knee implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the established industry standards (e.g., ASTM F1800, ASTM F1044, ANSI/AAMI ST 72:2019). The tests measure physical properties against defined limits or performance benchmarks within these standards.
8. The sample size for the training set
Not applicable. This is a physical device, and the evaluation is based on non-clinical engineering and material tests, not on machine learning or AI models which would require training sets.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.