(95 days)
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The Pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.
The provided text describes the iASSIST Knee System, a computer-assisted stereotaxic surgical instrument system. While it outlines the system's purpose, design, and general testing, it does not include acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.
However, I can extract the information that is present regarding the studies and ground truth:
General Information on Performance Data:
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Device Performance Testing:
- Physical/Performance Tests: Conducted to ensure performance of implemented features and verify related design inputs.
- Engineering Analysis: Conducted to ensure performance of implemented features and verify related design inputs.
- Usability Engineering: Addressed user interactions with the iASSIST Knee System.
- Validation Lab: Performed to validate that using the iASSIST Knee System is safe and effective and that its performances are acceptable under full simulated use on cadaveric specimens.
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Software Verification and Validation Testing:
- Conducted to satisfy requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304.
- The software is considered a "moderate" level of concern.
- Testing demonstrates that the iASSIST Knee System does not raise any new issues of safety and effectiveness compared to predicate devices.
Specific Study Details (based on the provided text's limitations):
- Table of Acceptance Criteria and Reported Device Performance: Not provided in the text.
- Sample Size used for the test set and data provenance:
- Test Set Sample Size: "cadaveric specimens" were used in the Validation Lab. The exact number is not specified.
- Data Provenance: The Validation Lab study involved "full simulated use on cadaveric specimens." No country of origin is specified for the cadavers or data. It appears to be a prospective simulation study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.
- Adjudication method for the test set: Not specified in the text.
- 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 specified in the text. The device is a surgical instrument system, not an imaging interpretation AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The text mentions "computer assisted stereotaxic surgical instrument system to assist the surgeon". The validation lab involved "full simulated use on cadaveric specimens," implying human interaction is part of its intended use and testing. A "standalone" performance without human input is not described.
- The type of ground truth used:
- For the "Validation Lab" testing, the ground truth would likely refer to the actual anatomical alignments or target positions in the cadaveric specimens, which would then be compared against the system's measurements and guidance. However, the exact method for establishing this ground truth is not detailed (e.g., whether it relied on pre-defined anatomical markers, precise physical measurements independent of the device, or other methods).
- The sample size for the training set: Not applicable and not mentioned. This device is a surgical navigation system, not a typical machine learning algorithm that requires a separate training set in the conventional sense. The software is verified and validated, but does not appear to be "trained" on a dataset in the way an AI diagnostic tool would be.
- How the ground truth for the training set was established: Not applicable (see point 8).
In summary, the provided document focuses on the regulatory submission, equivalence to predicate devices, and general categories of testing performed. It lacks the specific quantitative performance metrics, acceptance criteria, and detailed study methodologies typically required to fill out the requested table for an AI/device performance study.
§ 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).