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The Voyager Linux 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 orientation and reference information during intra-operative procedures.

The Voyager Linux 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 rigid anatomical structure may be made, such as:

• Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
• Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
• ENT Procedures
• Orthopedic surgical procedures

The Voyager Linux is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. Voyager Linux uses patient data to assist the physician with presurgical planning and interpretive navigation. The TGS, which is an add-on to the Voyager Linux, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 300 party drill systems.

The Voyager Linux consists of the following basic components:

• High Resolution color liquid crystal display (LCD) touch screen monitor
• Uninterruptible Power Supply (UPS)
• Central Processing Unit (CPU)
• Isolation Transformer
• Keyboard and Mouse
• Optical Detector
• Operating Room Cart
• Tool and accessories surgical tools and accessories instrumented with reflective markers.
• TGS connected to the Voyager Linux platform to enable stereotactic guidance of standard surgical tools.
• Software application specific software provided as part of system or via standard media (e.g., CD-ROM)

The provided document for the MAKO Surgical Corp. "Voyager Linux" device (K050973) is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. This type of document typically does not contain detailed information about specific acceptance criteria, a comprehensive study report with quantitative performance data against those criteria, or the methodology for establishing ground truth, as would be found in a full clinical or validation study report.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or explicitly stated from the document, and what is missing:

1. A table of acceptance criteria and the reported device performance

• Missing: The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision measurements) for the device's performance, nor does it provide a table of reported device performance against such criteria. The "performance" described is primarily in terms of demonstrating substantial equivalence to a predicate device and confirming the functionality of the added Tactile Guidance System (TGS).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing: The document does not describe a "test set" in the context of a validation study with specified sample sizes or data provenance. The 510(k) summary states, "As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence." This is a high-level statement without details on the specific data used for these activities.

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)

• Missing: This information is not present. The document mentions "designated individuals" performing verification and validation, but does not detail how ground truth was established for any test data, nor the number or qualifications of experts involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing: No information on an adjudication method for a test set is provided.

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

• Missing: The document does not mention an MRMC study or any comparative effectiveness study involving human readers with or without AI assistance. The device (Voyager Linux with TGS) is an image-guided surgical device that provides "stereotactic guidance," not an AI-based diagnostic tool that assists human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Missing: The device is described as an "image-guided surgical device" and an "intelligent tool holder or tool guide used by a surgeon." This implies a human-in-the-loop system, where the TGS assists the surgeon. The document does not present any standalone algorithm performance separate from its use by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing: The document does not specify the type of ground truth used for any validation activities. Given the device's function (surgical guidance), ground truth would typically relate to the accuracy of tool placement or anatomical registration, but this is not detailed.

8. The sample size for the training set

• Missing: The document does not discuss a "training set" as it would for a machine learning or AI-driven system. The device primarily uses patient diagnostic images for "presurgical planning and interpretive navigation" and provides software-defined spatial boundaries. This implies programmed instructions and image processing, rather than a system trained on a large dataset in the modern AI sense.

9. How the ground truth for the training set was established

• Missing: As no training set is discussed, there is no information on how its ground truth might have been established.

Summary based on available information:

The provided document is a 510(k) summary for a medical device (Voyager Linux with Tactile Guidance System). Its purpose is to demonstrate substantial equivalence to a previously cleared predicate device, rather than to present a detailed study proving performance against specific acceptance criteria for an AI or diagnostic application. The document states that "all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence," but it does not elaborate on the specifics of these activities, including sample sizes, ground truth establishment, or detailed performance metrics.

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