(140 days)
The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
TKA Pro software application is specifically indicated for Total Knee Arthroplasty.
The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.
The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.
The ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.
The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.
This document describes the ExactechGPS® System, a surgical navigation system, and its modifications. While the document mentions general performance tests, electrical safety, EMC compatibility, photobiological safety, biocompatibility, and cleaning/sterilization validation, it does not provide the specific details required to fully address your request regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/human-in-the-loop system.
The device described is a "stereotaxic instrument" and mentions a "TKA Pro software application" for Total Knee Arthroplasty, aiding surgeons in locating anatomical structures and aligning endoprostheses. This implies a core functionality related to precise surgical guidance.
Given the information provided in the document, here's what can be extracted and what is missing:
Information Provided:
- Device Name: ExactechGPS® System
- Intended Use: "intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty."
- Modifications: New set of ExactechGPS Trackers V2 (different architecture, updated electronic card, InfraRed bandpass filter) and compatibility with only the TKA Pro clinical software application (whereas the predicate was compatible with TKA Pro and TKA Plus).
- Claimed Impact of Modifications: "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used: The proposed ExactechGPS Trackers V2 have the same general features and dimensions, with the same technology and performances. The redesigned electronic card only resolves obsolescence issues with no impact on user, performance and safety. The new InfraRed bandpass filter only improves communication reliability."
- Non-Clinical Testing: General Functions tests, Electrical Safety (IEC 60601-1), EMC Compatibility (IEC 60601-1-2), Photobiological Safety (EN 62471), Biocompatibility (ISO 10993-1:2018), Cleaning and Sterilization Validation (ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020, AAMI TIR30:2011/(R) 2016).
Information NOT Provided (or not in sufficient detail):
- Specific Acceptance Criteria and Performance Data for Surgical Accuracy/Clinical Outcome: While "General Functions tests" are mentioned, no quantitative acceptance criteria for surgical accuracy (e.g., angular or translational precision of component placement) or specific performance results (e.g., mean angular deviation, success rate) are presented in a table format as requested. The document states "the proposed changes do not alter significantly the performances," implying a comparison to the predicate, but no specific performance metrics are given.
- Sample Size for Test Set and Data Provenance: Not specified for any study related to the device's functional performance in surgical guidance. The document mentions "test bench testing" but no details on the size or nature of the test set.
- Number of Experts and Qualifications for Ground Truth: Not applicable as no reader study or expert-based ground truth establishment is described for the device's performance. The device is a navigation system, so its "ground truth" would presumably be the physical reality of component alignment or anatomical structure location, measured by highly accurate metrology, rather than expert interpretation of images.
- Adjudication Method for Test Set: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned or implied. This device is a navigation system, not an AI diagnostic tool primarily assisting human readers in interpreting images.
- Standalone Performance (Algorithm Only): The device functions as a system with hardware and software; standalone algorithm-only performance is not directly relevant in the way it might be for an AI diagnostic algorithm.
- Type of Ground Truth Used: For a navigation system, ground truth would typically come from highly accurate metrological measurements of physical objects or cadaveric studies, not expert consensus on images or pathology. This exact type of ground truth is not explicitly detailed.
- Sample Size for Training Set: Not specified. It's unclear if "training" in the machine learning sense applies to this system's development, or if it refers to calibration/validation data for the navigation system.
- How Ground Truth for Training Set was Established: Not specified.
Based on the provided document, here's a structured response indicating available information and significant gaps:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Performance (e.g., Surgical Accuracy, Precision) | NOT SPECIFIED QUANTITATIVELY. The document states: - "General Functions tests to ensure design is fully verified and validated." - "The proposed changes do not alter significantly the performances of the devices and the way it is used." |
| There are no specific metrics (e.g., angular deviation, translational error) or numerical results provided to define acceptance criteria or demonstrate performance. | |
| Electrical Safety (IEC 60601-1) | Compliant with requirements of the standard. |
| EMC Compatibility (IEC 60601-1-2) | Compliant with requirements of the standard. |
| Photobiological Safety (EN 62471) | Compliant with requirements of the standard. |
| Biocompatibility (ISO 10993-1:2018) | Compliant with requirements of the standard. |
| Cleaning and Sterilization Validation (ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020, AAMI TIR30:2011/(R) 2016) | Compliant with requirements of the standards. |
| Compatibility with Tracker V2 Performance | "The proposed ExactechGPS Trackers V2 have the same general features and dimensions, with the same technology and performances." |
| Electronic Card Redesign Impact | "redesigned electronic card only resolves obsolescence issues with no impact on user, performance and safety." |
| Infrared Bandpass Filter Impact | "new InfraRed bandpass filter only improves communication reliability." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "test bench testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing was conducted "in-house and by accredited testing laboratories."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable as no expert-based ground truth establishment or reader study is described for the performance claims. The device is a navigation system; its performance would likely be evaluated against physical measurements.
4. Adjudication Method for the Test Set:
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No evidence of an MRMC study. The device is a surgical navigation system, not a diagnostic AI tool for image interpretation by human readers. Its primary function is to provide real-time guidance during surgery, not to enhance human interpretation of medical images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes the device as a system of hardware (trackers, station) and software. The listed "performance data" refers to general system functions and regulatory compliance (electrical safety, EMC, etc.). It does not detail a standalone algorithm-only performance study related to its core navigation accuracy. The "TKA Pro software application" is part of the system, not presented as a standalone AI for diagnosis.
7. The Type of Ground Truth Used:
- For a surgical navigation system, the ground truth for functional performance (like accuracy of component placement) would typically be established using highly accurate metrological measurements on physical models, cadavers, or potentially intraoperative measurements. This document does not specify the exact type of ground truth used for "General Functions tests" or "test bench testing" related to the navigation's accuracy. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.
8. The Sample Size for the Training Set:
- Not specified. It's unclear if "training set" refers to a machine learning training set or calibration data for the navigation system. The document does not describe an AI model that would require a distinct "training set" in the context of deep learning.
9. How the Ground Truth for the Training Set was Established:
- Not specified and likely not applicable in the context of an AI training set as described in the prompt, as the device is not presented as a deep learning AI diagnostic tool.
§ 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).