(117 days)
Zimmer Knee Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty (Primary and Revision)
Minimally Invasive Knee Orthopedic Procedures
This submission is for:
• Zimmer orthopedic manual knee instruments that have a slot that accommodates a Medtronic electromagnetic tracking sensor, and
• The addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.
Here's a breakdown of the acceptance criteria and study information for the Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Knee Instrumentation, based on the provided document:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly defines the acceptance criterion as demonstrating accuracy validation and verification for the instruments when used with Medtronic StealthStation Image Guidance Systems. The "Performance Data (Nonclinical and/or Clinical)" section is where this would be addressed.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance |
|---|---|---|
| Accuracy Validation | Instruments demonstrate accuracy when used in conjunction with Medtronic StealthStation Image Guidance Systems. | Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. (This statement indicates the device met this implicit criterion.) |
| Verification Testing | Instruments undergo verification testing. | Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. (Similar to above, this confirms verification testing was performed.) |
Study Details
This submission is for modifications to existing instruments (accommodating an electromagnetic tracking sensor and adding imageless referencing). The provided document is a 510(k) summary, which often relies heavily on substantially equivalent predicates and non-clinical testing for accessories.
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients. The testing was non-clinical performance and conclusions. This suggests testing in a lab or simulated environment rather than on human subjects.
- Data Provenance: Not applicable for clinical provenance as the study was non-clinical. The testing was conducted for instruments manufactured by Zimmer, Inc., which implies internal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was non-clinical accuracy validation and verification testing of instruments, expert human interpretation of images for ground truth was not required. The ground truth would likely be established by known physical measurements or established engineering standards.
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Adjudication method for the test set:
- Not applicable. Given the non-clinical nature of the testing, a human adjudication method (like 2+1 or 3+1) is not relevant.
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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:
- No. This device is an instrument for computer-assisted surgery, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The accuracy validation and verification testing of the instruments themselves would be standalone in demonstrating their performance. The instruments are accessories to Image Guided Surgery systems, meaning they perform their function (tracking, guiding) independent of human interpretation of the instrument's output for ground truth.
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The type of ground truth used:
- The document implies that the ground truth for the non-clinical accuracy validation and verification testing would be engineering measurements or established physical benchmarks. For example, the accuracy of tracking systems typically relies on known spatial coordinates or precise mechanical measurements.
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The sample size for the training set:
- Not applicable. This device is an instrument, not a machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on known physical principles and engineering design.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).