(161 days)
The Bone Anchor is intended to be used with commercially available stereotactic systems for intracranial and neurosurgical procedures which require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain, or nervous systems. It is designed to provide short-term fixation and positioning of compatible neurosurgical instruments or accessories under image-guidance.
The Bone Anchor is a single-use device for temporary short-term fixation of surgical tools or accessories during a single surgical procedure. The Bone Anchor may be used during image-guided or MR interventional procedures. This device is not intended to create a seal or barrier from potential infection and has not been tested for long-term (>24 hours) use. The Bone Anchor components are listed below along with their function:
- Bone Anchor (Skull Device) A device that is inserted into the Skull that is used . to hold an instrument or accessory in place after is it inserted to the desired position. Part of the Skull Fixation Device protrudes from the Skull.
- Bone Anchor Driver (Driver) An optional device used to position the Skull . Fixation Device into the skull.
- Bone Anchor Silicone Seal A device within the Bone Anchor which is . compressed against the inserted instrument or accessory when the Cap is tightened, thereby holding the instrument or accessory in place.
- Bone Anchor Cap A device which connects to the Bone Anchor and, when . tightened, compresses the Silicone Seal against the inserted instrument or accessory.
- . Bone Anchor Cover - An optional device which is placed over the Cap when inserting a flexible instrument or other accessory and can be locked into place on the Cap to secure the accessory.
The provided text is a 510(k) summary for the ClearPoint Neuro Bone Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not available in this document.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance testing for the Bone Anchor and mentions testing for the predicate and reference devices. However, it does not explicitly
state specific acceptance criteria or provide quantitative performance results (e.g., exact load values, push force values, or targeting error measurements) for the Bone Anchor, only noting that "meets all test specifications" for demonstrating substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Load Testing | Not explicitly stated (Met test specifications) |
| Push Force Testing | Not explicitly stated (Met test specifications) |
| Insertion Force Testing | Not explicitly stated (Met test specifications) |
| Retention Force Testing | Not explicitly stated (Met test specifications) |
| Removal Force Testing | Not explicitly stated (Met test specifications) |
| Driver Pull Force Testing | Not explicitly stated (Met test specifications) |
Note: The document states that the subject device "meets all test specifications" and performs "as well as the predicate device" but does not provide the numerical values for these specifications or the device's performance against them. Similarly, for the predicate Microtable, it lists "Dimensional Stability" and "Load Testing" but no specifics. For the reference device, it lists the same tests as the subject device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the described performance testing. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes engineering and mechanical performance testing, not a study involving human experts establishing ground truth for clinical data.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human assessment of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing and comparison to predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
For the performance testing mentioned (Load, Push Force, Insertion Force, Retention Force, Removal Force, Driver Pull Force Testing), the "ground truth" would be established by the engineering and mechanical testing standards and methodologies used to evaluate the device's physical properties and functionality. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical instrument and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, 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).