(137 days)
The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.
The Search Evolution non-porous titanium plasma spray coated femoral components are designed for use with bone cement.
The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both fernoral components are manufactured from CoCrMo. The titanium plasma spray coated femoral components are intended to be used with bone cement (previously cleared in K021313). It conforms to ISO 5832 and is applied using the plasma spray technique.
This 510(k) submission (K070981) describes the substantial equivalence of the Search Evolution Knee System Ti, Plasma Spray Femoral Component to previously marketed devices. It does not contain information about the performance of a software device or an AI algorithm, therefore, it does not fit the typical structure requested for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance.
The document focuses on the material and design similarity of a physical medical device (a knee implant component) to its predicates, rather than the performance of a diagnostic or predictive algorithm.
Therefore, for aspects like "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set," the information is not applicable to this type of device submission.
However, I can extract the information relevant to the device as presented in the document:
Acceptance Criteria and Device Performance for a Physical Medical Device (Knee Implant Component)
This submission describes the substantial equivalence of the Search Evolution Knee System Ti, Plasma Spray Femoral Component, a physical medical device, not a software or AI device. Therefore, the "acceptance criteria" and "device performance" are related to manufacturing, material characteristics, and comparison to predicate devices, rather than diagnostic accuracy or algorithmic performance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by equivalence to predicates) | Reported Device Performance (as stated in submission) |
|---|---|
| Design and Fundamental Technology Equivalence: The device's design and underlying technology should be substantially similar to predicate devices. | "The titanium plasma spray coated femoral components are intended to be used with bone cement (previously cleared in K021313). It conforms to ISO 5832 and is applied using the plasma spray technique." |
"Aesculap believes that the titanium plasma spray coated femoral component of the Search Evolution Total Knee System is substantially equivalent in design fundamental technology, and coating when compared to:
- Aesculap Search Evolution Porous Coated Femoral Component (K032108)
- Aesculap Bicontact Hip System (K040191)
- Aesculap Excia Total Hip System (K042344)
- Aesculap Search Evolution Total Knee System (K021313)" |
| Coating Performance Equivalence: The titanium plasma spray coating should perform similarly to coatings on previously cleared devices. | "The Aesculap titanium plasma spray coated femoral components are considered substantially equivalent to other legally marketed systems with a titanium plasma spray coating. Testing done on the plasma spray coating found it to be similar in performance to previously cleared devices with the same type of coating." |
| Compliance with Relevant Guidance Documents: Devices should meet testing requirements outlined in specific FDA guidance. | "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the; - 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces . Apposing Bone or Bone Cement',
- 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements'." |
| Intended Use Equivalence: The device's intended use should align with predicate devices. | "The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.
The Search Evolution non-porous titanium plasma spray coated femoral components are designed for use with bone cement." (This matches the general intended use of predicate knee implants). |
Regarding the specific questions about studies for AI/software devices:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical device 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 a physical device submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical device submission. The "adjudication" here would be the FDA's regulatory review process.
- 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 physical device submission.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device submission.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical devices, "ground truth" relates to material properties, biocompatibility, mechanical strength, and manufacturing specifications, often evaluated against recognized standards (like ISO 5832 mentioned for CoCrMo) and predicate device data.
- 8. The sample size for the training set
- Not Applicable. This is a physical device submission.
- 9. How the ground truth for the training set was established
- Not Applicable. This is a physical device submission.
§ 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.