(18 days)
The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oxientation and reference information during intra-operative procedures.
The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a tigid anatomical structure may be made, such as:
- . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms
- ENT Procedures .
- Orthopedic surgical procedures ●
The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
The document provided is a 510(k) summary for the Z-KAT, Inc. Voyager Linux stereotaxic instrument. This type of regulatory document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results or acceptance criteria for a new device's performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and its substantial equivalence to an existing device (Voyager 6.0 Software Option; Marconi Medical Systems, K000310).
Here's what can be stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document does not define specific performance acceptance criteria for the Voyager Linux device, nor does it report performance metrics against such criteria. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence in design, materials, and intended use as opposed to new clinical efficacy/performance trials against predefined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document does not mention any specific test sets, sample sizes, or data provenance related to a performance study for the Voyager Linux device.
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)
- Cannot be extracted. No information is provided about experts used for ground truth establishment, as no test set or performance study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No information about adjudication methods is provided, as no test set or performance study is detailed.
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
- Cannot be extracted. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance. The Voyager Linux is described as an image-guided surgical device, not an AI-driven diagnostic tool that would typically involve "human readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. The document does not describe any standalone performance studies. Given it's a "stereotaxic instrument" and "image guided surgical device," it inherently involves human interaction and is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. As no performance study is described, no information on the type of ground truth used is available.
8. The sample size for the training set
- Cannot be extracted. The document does not mention any training sets, as it is not describing a machine learning or AI algorithm in the context of a new development or training process.
9. How the ground truth for the training set was established
- Cannot be extracted. As no training set is mentioned, there is no information on how its ground truth was established.
Summary of available information:
- Device Name: Voyager Linux
- Predicate Device: Voyager 6.0 Software Option; Marconi Medical Systems, K000310
- Device Description: An image-guided surgical device including an optical detector, computer, dedicated instrumentation, and operating software. Uses diagnostic images for pre-surgical planning and intra-operative navigation.
- Intended Use/Indications: To assist physicians with presurgical planning and to provide orientation and reference information during intra-operative procedures for stereotactic surgery involving rigid anatomical structures. Specifically mentioned for:
- Intra-cranial surgical procedures (space occupying lesions, malformations including soft tissue, vascular, osseous)
- Spinal surgical procedures (stabilization, neural decompression, resection of spinal neoplasms)
- ENT procedures
- Orthopedic surgical procedures
In conclusion, the document serves its purpose as a 510(k) summary for substantial equivalence but does not provide the detailed performance study information requested.
§ 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).