(24 days)
EXULT Knee Replacement System is intended for the treatment of diseases as follows:
· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
· Post-traumatic loss of knee joint configuration and function;
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
EXULT Knee Replacement System is intended for cemented application only.
The Additional components being added to the EXULT Knee Replacement System are:
- Instrumentation (Femoral Component Trial) -
The subject EXULT Knee Replacement System components specification inclusions are a line extension of Instrumentation (Femoral Component trial). The following is the additional components.
A) Instrumentation (Femoral Component Trial)
A copy of a final femur prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material. This instrument is a reusable device that must be sterilized prior to use.
Additional Femoral Component Trials are designed based on Femoral Component Trials of predicate device cleared EXULT Knee Replacement System Instrumentation under K200395. This femoral component trials are made of Stainless steel alloy conforming to ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
This document describes the premarket notification (510(k)) for the EXULT Knee Replacement System, specifically focusing on the addition of new instrumentation (Femoral Component Trial). It is not a study proving device performance against acceptance criteria for an AI/ML diagnostic or prognostic device.
The provided text describes a submission for a medical device (a knee replacement system and its associated surgical instrumentation), not an AI/ML-based diagnostic or prognostic device. Therefore, the questions related to clinical studies, ground truth establishment, expert consensus, and effects of AI on human readers are not applicable.
The "acceptance criteria" in this context refer to the FDA's requirements for demonstrating substantial equivalence for a medical device. The "study" proving the device meets these criteria is the non-clinical testing performed and the comparison to a predicate device.
Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for an AI/ML-focused query:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Non-Clinical Testing/Comparison) |
|---|---|
| Same Intended Use | EXULT Knee Replacement System has the same intended use as the predicate device (K200395). |
| Same Indications for Use | EXULT Knee Replacement System has the same indications for use as the predicate device. |
| Same Operating Principles | EXULT Knee Replacement System incorporates the same operating principles as the predicate device. |
| Same Basic Designs | EXULT Knee Replacement System incorporates the same basic designs as the predicate device. |
| Same/Similar Materials | Additional Femoral Component Trials are made of Stainless steel alloy conforming to ASTM F899, similar to predicate device materials. |
| Supplied Non-Sterile | EXULT Knee Replacement System Instrumentation is supplied non-sterile, consistent with predicate devices. |
| Dimensions Measurement Testing | Performed: Dimensions of additional instruments are exactly the same as predicate devices. |
| Assembly Testing | Performed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of an AI/ML device. The testing involved dimensions measurement and assembly testing of the physical instrumentation. The document does not specify a "sample size" in terms of number of instruments tested, but rather refers to "additional instruments (Femoral component trials)".
- Data Provenance: The manufacturer is Corentec Co., Ltd. from South Korea. The testing was conducted by the manufacturer as part of their submission process. This would be considered internal, retrospective testing for the purpose of regulatory submission.
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/ML device requiring expert-established ground truth. The "ground truth" for demonstrating substantial equivalence rests on comparing the new device's characteristics and performance to the established predicate device and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no expert adjudication process as this is not an AI/ML device.
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/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" for this medical device submission is the established characteristics and performance of the legally marketed predicate device (K200395) and adherence to material standards (ASTM F899).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.