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Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, VIPER PRIME®, EXPEDIUM VERSE®, and SYMPHONYTM OCT screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

The provided FDA 510(k) summary for the "Navigation Enabled Instruments" (K200791) describes the device, its intended use, and a performance study. However, it does not contain the detailed acceptance criteria or the specific results in a format that would allow for a direct numerical comparison as requested in your prompt.

Specifically, the document states that "Simulated Use testing was performed" and lists what this testing aimed to demonstrate, but it does not provide:

• A table of quantitative acceptance criteria (e.g., specific accuracy thresholds)
• The reported device performance against those criteria (e.g., measured accuracy values)
• Sample sizes for test sets (it mentions "clinically relevant anatomical specimen / model" but not the number)
• Data provenance (country of origin, retrospective/prospective)
• Number/qualifications of experts for ground truth
• Adjudication method
• MRMC study information
• Standalone performance data
• Type of ground truth used (beyond "anatomical specimen / model")
• Sample size for training set
• How ground truth for the training set was established

Key information that can be extracted from the provided text, related to the performance study, is as follows:

1. Acceptance Criteria and Reported Device Performance:

The document describes the objectives of the simulated use evaluation, which implicitly define the areas for which performance must be acceptable. However, it does not state specific numerical acceptance criteria or the reported device performance against them.

• Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity). |
  | Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification). |
  | Navigation Enabled Instruments can be accurately navigated, and screws accurately placed. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification). |

2. Sample size used for the test set and the data provenance:

• Sample Size: The document mentions "a clinically relevant anatomical specimen / model." It does not specify the number of specimens/models used or the number of trials/measurements performed.
• Data Provenance: The study was a "Simulated Use testing," implying it was conducted in a controlled environment, likely at the manufacturer's facility. No information on country of origin of data, or whether it's retrospective or prospective is provided, though based on "simulated use," it's prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The ground truth would likely be established by the physical properties of the "anatomical specimen / model" and the known dimensions/placement attempts, but expert involvement for ground truth definition is not mentioned.

4. Adjudication method for the test set:

• This information is not provided in the document. Given it's a simulated use test on a model, formal adjudication as seen in clinical trials with human data is unlikely to be described here.

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:

• No MRMC comparative effectiveness study is mentioned. The device is a navigation system for surgical instruments, not an AI-assisted diagnostic or interpretive tool that would typically involve "human readers" in this context. The evaluation focuses on the instrument's performance, not human reader improvement.

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

• The device inherently involves human-in-the-loop, as they are "Navigation Enabled Instruments" intended to "assist the surgeon." Therefore, a "standalone algorithm only" performance study is not applicable or described for this type of device. The simulated use testing inherently includes the human (or simulated human interaction) with the system.

7. The type of ground truth used:

• "Clinically relevant anatomical specimen / model." This typically refers to cadaveric specimens or realistic physical models that mimic human anatomy. The ground truth for accuracy would be based on the known anatomical landmarks or pre-defined target locations within these models.

8. The sample size for the training set:

• This information is not provided. This device is largely mechanical and optical (for navigation) rather than a machine learning/AI device that typically requires a discrete "training set" in the conventional sense. Its "training" would be through engineering design, calibration, and predicate device experience.

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

• This information is not provided, and as noted above, a formal "training set" and its ground truth establishment, as understood in AI/ML contexts, is not explicitly documented for this type of medical device in this summary.

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