(28 days)
Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:
- Genesis II Knee System
- Legion Knee System
- Journey BCS Knee System
- Journey II Knee System
The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.
The subject of this premarket notification is to seek FDA clearance of software components to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K172336. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X-Ray). The blocks are intended to be used as patient-specific surgical instrument to assist in the positioning of total knee replacement implant components intra-operatively and in guiding the marking of bone before cutting.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks. It is a notification for a software component update, not for a new device requiring extensive clinical trials. Therefore, the information typically requested about acceptance criteria and study data for a new device's performance is largely not applicable or not detailed in this type of submission.
The document explicitly states:
- "No new mechanical testing was performed."
- "No implants or new blocks are being introduced in this premarket notification."
- "There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification."
- "Clinical data was not needed to support the safety and effectiveness of the subject device(s)."
The submission focuses on technological differences related to internal software components:
- "The use of a different X-ray measurement tool."
- "The upgrade of an alignment tool."
Software verification and validation testing was completed, which is the primary evidence for this submission.
Therefore, I cannot populate the table and answer the study-specific questions as they would apply to a clinical performance study of a new medical device. The document states that the device is "substantially equivalent" to a predicate device (K172336), and the current submission is for software updates to an already cleared device.
However, I can extract the relevant information about the software validation:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance for Software Validation) | Reported Device Performance |
|---|---|
| Software validation demonstrating performance as intended | Software verification and validation testing was completed in line with FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. This testing "demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended." |
2. Sample size used for the test set and the data provenance: Not applicable. This was a software validation, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a software validation.
4. Adjudication method for the test set: Not applicable. This was a software validation.
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 device is not an AI for human reader assistance; it's patient-matched surgical instrumentation software.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The software components were validated to perform as intended in the design and manufacture of the cutting blocks. This is a standalone software validation, not a clinical performance study.
7. The type of ground truth used: For software validation, the "ground truth" would be the specified functional requirements and design specifications of the software, verified through testing against those predefined requirements.
8. The sample size for the training set: Not applicable. This was a software validation for existing components, not a deep learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) pertains to software updates for an already cleared device, and thus, the primary evidence presented is software validation and a claim of substantial equivalence, rather than a new clinical performance study with patient data.
§ 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.