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The EBI® Acumen™ Surgical Navigation System is intended to assist the surgeon in accurately locating anatomical structures during open or percutaneous orthopedic surgical procedures. The EBI® Acumen™ Surgical Navigation System is indicated for use in spine and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy.

The EBI® Acumen Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-Kat, Inc., Hollywood, FL.
Passive markers(spheres) are attached onto the Acumen instrumentation. An infrared light source generated by the camera refects off the passive markers to allow their position and orientation to be identified. The Acumen instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.
All Acumen instruments will have a minimum of three (3) passive markers to be tracked by the camera. They will be rigidly connected to the instrumentation utilized in the surgical procedure and will have a defined geometry of the passive marker position for a unique identification by the camera and software system.
The instruments can be utilized in spine and trauma procedures and are designed as single use components.

The provided text describes the EBI® Acumen Surgical Navigation System, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics.

The document primarily focuses on establishing substantial equivalence for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device. This is often demonstrated by showing similar technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states "Software verification and validation was performed to establish substantial equivalence," but it does not detail the specific performance criteria or the results of these validation activities.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
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: This is a surgical navigation system, not an AI-assisted diagnostic tool. An MRMC study is not applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a surgical navigation system, inherently designed for human-in-the-loop use. Standalone performance as an "algorithm only" is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The document asserts that "Software verification and validation was performed to establish substantial equivalence to the predicate systems." This implies that some testing was conducted to ensure the software's functionality and safety. However, the details of what specific performance "acceptance criteria" were used (e.g., accuracy in locating anatomical structures within a certain tolerance) and the results of meeting those criteria are not disclosed in this 510(k) summary. The FDA's letter of clearance confirms that the device was deemed "substantially equivalent" to predicate devices, allowing it to be marketed, but this regulatory decision is based on the comparison to existing devices rather than a direct presentation of performance against novel acceptance criteria.

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