(170 days)
The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.
The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843.
This notification only relates to a revision of the Indications for Use to a closer alignment riflis notinoution only rolatoo to a rothfor the devices shown above to which Substantial Equivalence is claimed.
All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.
This 510(k) premarket notification (K013428) for the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System is a submission for a revised indication for use for an already cleared device. Therefore, it does not contain a new study that proves the device meets specific acceptance criteria related to performance metrics (e.g., accuracy, sensitivity, specificity).
The core of this submission is a claim of substantial equivalence to previously cleared devices (K981686, K003699, K001153, K005389) and a revision to the Indications for Use statement. It explicitly states: "The devices are not changed either in hardware or software. This notification only relates to a revision of the Indications for Use..."
As such, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, because a new study demonstrating such performance was not conducted or submitted with this specific 510(k). This particular submission leverages the performance established in the predicate devices and focuses on broadening the scope of its clinical utility.
Therefore, most of the sections of your request are not applicable to this document. I will fill in the information that is available.
Acceptance Criteria and Device Performance Study for K013428: MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System
This 510(k) submission (K013428) is for a revised indication for use of an existing device, the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System. The document explicitly states: "The devices are not changed either in hardware or software." and "This notification only relates to a revision of the Indications for Use..."
Therefore, this submission does not include a new study with specific acceptance criteria and reported device performance metrics (such as accuracy, sensitivity, specificity, detection rate, etc.) for a novel or modified device. The substantial equivalence is based on the previously cleared predicate devices and the unchanged hardware/software.
Table of Acceptance Criteria and Reported Device Performance:
Since no new performance study was conducted or presented in this 510(k), this table cannot be populated with new device performance against acceptance criteria. The device's performance is assumed to be consistent with the predicate devices and its prior clearances (K955397, K982244, K991267, and K992843).
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable, as this submission is for a revised indication for use, not a new performance study. | Not applicable, as this submission is for a revised indication for use, not a new performance study. |
1. A table of acceptance criteria and the reported device performance:
- Not applicable. This 510(k) does not present new performance data or acceptance criteria as it's for a revised indication of an existing, unchanged device.
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. No new test set data was provided or generated for this 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. No new ground truth establishment was described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new adjudication method was described for this submission.
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. The device described is a computer-based image-guided stereotactic planning system, not an AI-assisted diagnostic device where "human readers improve with AI vs without AI assistance" would be a relevant metric. Furthermore, no MRMC study was mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission focuses on a revision of indications for use for an existing surgical navigation system. Standalone algorithm performance, in the context of typical AI/diagnostic devices, is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No new ground truth establishment was described for this submission. For surgical navigation systems, the 'ground truth' often relates to the physical accuracy of the navigation relative to anatomical landmarks, but no new study measuring this was presented.
8. The sample size for the training set:
- Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.
9. How the ground truth for the training set was established:
- Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.
§ 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).