(428 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as clinical testing was not conducted to establish substantial equivalence. Instead, software verification and validation were performed. | Not applicable, as no clinical performance data are presented in this 510(k) summary. |
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.
§ 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).