(85 days)
The Orthopilot® Next Generation Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement.
Aesculap's OrthoPilot Next Generation is a computer assisted surgical navigation system that uses proprietary software to provide optimal anatomical information to a surgeon. The hardware in the system consists of the following primary components: stereotaxic camera, computer (w/ monitors), rigid bodies (transmitters), power supply, various taqged instruments, an ultrasound module, transport cart and stand. The computer accepts input from the transmitters on the rigid bodies either mounted to the patients bones or mobile to palpate anatomical landmarks in conjunction with a camera to monitor the spatial location of the transmitters in relation to each other and/or instruments. The computer also can accept spatial input for anatomical landmarks from an ultrasound unit. The software modules for the OrthoPilot Next Generation consist of modules for both a knee suite and a hip suite.
The provided text is a 510(k) summary for the Aesculap Orthopilot Next Generation, a surgical navigation platform. It does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment details, expert qualifications, or MRMC study results. The document primarily focuses on establishing substantial equivalence to a predicate device based on hardware upgrades, with the software remaining unchanged from a previously cleared version.
Therefore, most of the requested information cannot be extracted from this document.
Here's a summary of what can be extracted:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is substantial equivalence.
Study Details
The document does not describe a clinical study or performance study that would entail acceptance criteria, sample sizes, ground truth, or expert involvement as described in the prompt.
Information Not Found in the Document:
- Acceptance Criteria Table: No specific quantitative acceptance criteria are listed.
- Reported Device Performance: No performance metrics are provided.
- Sample size for the test set: Not mentioned.
- Data provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable as no such study is described.
- Standalone (algorithm only) performance study: Not mentioned.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
What is mentioned:
The document states that a "Performance Data" section is included, but it focuses on compliance with promulgated standards and software development principles, rather than clinical performance metrics.
- "No applicable performance standards have been promulgated under FDCA Section 514 for this system."
- "The previously cleared software modules were developed in accordance with Aesculap's internal SOP's as well as CDRH's 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff.'"
- The device complies with:
- IEC 60601-1 (International Electrotechnical Commission: Medical Electrical Equipment, Part 1: General Requirements for Safety)
- IEC 60601-1-2 (International Electrotechnical Commission: Medical Electrical Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests)
The basis for clearance is "Substantial Equivalence" to the Aesculap OrthoPilot 2 system (cleared in K013569). The key point for substantial equivalence is that "The OrthoPilot Next Generation navigation system merely represents an across the board upgrade in hardware technology and connectivity" and "The software that has been previously cleared for OrthoPilot 2 is compatible with OrthoPilot Next Generation and remains unchanged." This implies that clinical performance studies were not deemed necessary for this 510(k) clearance due to the software being identical to a previously cleared version and the changes being hardware-only.
§ 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).