(160 days)
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The MOTO™ Partial Knee System is a knee prosthesis designed for cemented use in medial compartment partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The femoral component is made of cobalt-chromiummolybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Partial Knee System implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.
The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs for sizes 1 to 7 and three (3) fixation pegs for sizes 8 to 10. Available in ten (10) sizes (1 - 10), the femoral component is offered in both Right Medial (RM) and Left Medial (LM) options for each size.
The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).
The Medial Fixed Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability. Available in five (8) sizes (1 - 8), the Medial Fixed Tibial Tray are offered in both Right Medial (RM) and Left Medial (LM) options for each size.
The document provided is a 510(k) premarket notification for the MOTO™ Partial Knee System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria for device performance in a clinical setting in the way an AI/ML device submission would.
Therefore, the specific information requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is not applicable to this type of device submission.
The "performance testing" section refers to bench testing and validation of the device's physical properties and manufacturing processes, not clinical or diagnostic performance.
Here's a breakdown of what is available in the document related to "acceptance criteria" and "device performance" in the context of this orthopedic implant:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria and performance in a table for clinical metrics like sensitivity or specificity. Instead, the "performance testing" section lists various validation studies conducted to ensure the device meets engineering, material, and manufacturing standards. The implied "acceptance criteria" for these tests are generally compliance with the relevant ASTM/ISO standards. The "reported device performance" is essentially that the device passed these tests and is thus considered substantially equivalent to the predicate.
| Performance Test | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fatigue under dynamic physiological loads | Compliance with ASTM F1800 | Device passed, deemed substantially equivalent to predicate |
| Excessive wear | Compliance with ASTM F2083 | Device passed, deemed substantially equivalent to predicate |
| Sterilization validation (Gamma Radiation) | Compliance with ANSI/AAMI/ISO 11137-1:2006, ANSI/AAMI/ISO 11137-2:2006 | Validation performed, ensuring sterility for sterile products |
| Sterilization validation (Ethylene Oxide) | Compliance with ISO 11135-1:2007 (for the Fixed Tibial Insert) | Validation performed, ensuring sterility for sterile products |
| Accelerated and real-time aging | Demonstrate device integrity and material stability over its specified shelf life (5 years) | Device passed, ensuring long-term performance and shelf life |
| Packaging validation | Ensure packaging maintains sterility and device integrity | Validation performed, ensuring device protection and sterility |
| Limulus Amebocyte Lysate (LAL) testing (Pyrogenicity) | Meet pyrogen limit specifications | Device meets pyrogen limit specifications |
2. Sample size used for the test set and data provenance:
- Not applicable for clinical performance. The "test set" here refers to samples of the device components used in bench testing. The specific number of samples for each engineering test (e.g., number of femoral components tested for fatigue) is not provided in this summary document.
- Data Provenance: Not specified, but standard for device manufacturers conducting in-house or contracted lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to clinical diagnostic performance. For mechanical and material testing, the "ground truth" is established by the test standard itself and the measurements taken by qualified technicians/engineers against the specified parameters.
4. Adjudication method for the test set:
- Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretation, not for objective engineering measurements.
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 an orthopedic implant, not an AI/ML diagnostic device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an orthopedic implant, not a standalone AI algorithm.
7. The type of ground truth used:
- Not applicable for clinical performance. For the engineering tests, the "ground truth" is defined by the physical properties of the materials and the mechanical behavior of the device components as measured against established scientific and engineering principles and standards (e.g., ASTM, ISO).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device's submission as it's not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this device.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.