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The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surgical knee and hip procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures, can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). These procedures include, but are not limited to, knee and hip arthroplasty procedures.

The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).

Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of 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 system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, 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 with knee and hip applications. The Acumen™ instruments are designed as one-time use components.

The Acumen™ Surgical Navigation System is a Class II device (21 CFR 882.4560, Stereotaxic Instrument) indicated for use in surgical knee and hip procedures where stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). This includes, but is not limited to, knee and hip arthroplasty procedures.

No clinical testing was used to establish substantial equivalence for this device. Instead, substantial equivalence was established through software verification and validation. Therefore, the information typically associated with acceptance criteria from clinical studies is not available in the provided document.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical testing was performed and substantial equivalence was based on software verification and validation, there are no specific performance criteria or reported device performance metrics in the document that would typically be found in a clinical study for diagnostic accuracy or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set data is reported as clinical testing was not used to establish substantial equivalence. Software verification and validation would have internal test sets, but details are not provided in this regulatory summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for clinical performance was not established as no clinical testing was performed to establish substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical testing or MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

While the device's function is an algorithm-driven navigation system, no standalone performance evaluation in a clinical or simulated clinical setting is described in this document. Substantial equivalence was based on software verification and validation, but the details of this testing (e.g., specific metrics, test cases) are not provided.

7. Type of Ground Truth Used

For the software verification and validation, the ground truth would likely refer to expected and validated software behaviors, calculations, and system outputs. However, the exact nature of this "ground truth" (e.g., established engineering specifications, mathematical models, simulated inputs with known correct outputs) is not detailed in the provided document. Clinical ground truth (e.g., pathology, outcomes data) was not used.

8. Sample Size for the Training Set

Not applicable. If machine learning was used, details of the training set are not provided. The document focuses on software verification and validation, not on a machine learning-based development paradigm where a distinct training set would typically be described.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no clinical training set is mentioned, the method for establishing its ground truth is not relevant here.

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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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The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ Navigation System is indicated for use in surgical knee 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. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).

Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of 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 system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, 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 with knee and trauma applications. The Acumen™ instruments are designed as one-time use components.

This FDA 510(k) summary for the Acumen™ Surgical Navigation System indicates that no clinical testing was performed to establish substantial equivalence. Therefore, there is no study provided within this document that demonstrates the device meets specific acceptance criteria based on clinical performance.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing, specifically software verification and validation.

Here's the breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed and no specific performance metrics with acceptance criteria are listed for the non-clinical testing, this table cannot be populated from the provided text. The document only states that "Software verification and validation was performed to establish substantial equivalence to the predicate devices." This implies that the acceptance criteria for software verification and validation were met, but these criteria are not detailed (e.g., accuracy tolerances, latency, reliability metrics).

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

• Test Set Size: Not applicable as no clinical test set was used.
• Data Provenance: Not applicable as no clinical data was used.

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

• Number of Experts: Not applicable as no clinical test set requiring expert ground truth was used.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable as no clinical test set was used.

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:

• MRMC Study: No. The document explicitly states "Clinical testing was not used to establish substantial equivalence." This type of study would fall under clinical testing.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. While the device is a navigation system that uses software, a standalone performance study in the context of clinical outcomes (e.g., surgical accuracy based on the algorithm's output alone) was not done. The "software verification and validation" addresses the functional correctness of the algorithm but not its clinical performance as a standalone tool.

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

• Ground Truth Type: Not applicable for clinical performance. For the software verification and validation, the ground truth would typically be the expected functional behavior and output defined by the software requirements and design specifications.

8. The sample size for the training set:

• Training Set Size: Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense for learning from data. The software described is an established navigation system using defined geometries and calculations for tracking.

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

• Ground Truth Establishment: Not applicable as no training set was used.

In summary:

The provided document relies entirely on non-clinical software verification and validation to establish substantial equivalence for the Acumen™ Surgical Navigation System. It explicitly states that no clinical testing was performed. Therefore, information regarding acceptance criteria derived from clinical studies, expert-adjudicated ground truth, or study methodologies for clinical performance is not available in this document.

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