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The CarpX is indicated for the minimally invasive isolation and incision/division of ligaments, tendons, or fascia such as the transverse carpal ligament for treatment of carpal tunnel syndrome.

Device Description

The CarpX device is a sterile, single-use, hand-held, bipolar high frequency precision electrosurgical cutting tool. As with other electrosurgical tools, CarpX functions by passing energy controlled by the electrosurgical generator to tissue. CarpX is designed to mimic a mechanical cutting blade by delivering a short, focused burst of cutting radiofrequency (RF) energy from an electrosurgical generator along a narrow line on the target tissue. The RF energy cuts the target tissue along this line during minimally invasive surgical procedures, including the isolation and division of ligaments, tendons, and fascia such as the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

CarpX consists of two integrated components: a proximal handpiece and a distal end. The proximal handpiece consists of a user interface with integrated finger switches and indicator lights, a cable to interface with the electrosurgical generator, a guidewire lumen and a balloon inflation port. The distal end consists of active and return electrodes, an inflatable balloon, a flexible shaft and an insulating electrode spacer.

AI/ML Overview

The provided document describes the CarpX device for minimally invasive incision/division of ligaments, tendons, or fascia, specifically for carpal tunnel syndrome. It details performance data from various studies.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria table" with numerical thresholds for performance metrics. Instead, "acceptance criteria" are implied by the successful completion of various tests and the absence of specific adverse outcomes or errors.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Bench Testing	CarpX meets functional, performance, design, and safety requirements. System requirements verification (Design Verification, Hardware Verification), Intended Use validation (Design Validation), User Interface validation (Usability), Packaging integrity, Biocompatibility, Sterilization (SAL of 10^-6), Shelf Life, Software V&V, EMC/Electrical Safety.	"Comprehensive bench tests were developed to verify design input requirements, demonstrate mechanical and system robustness, validate the user interface features, and validate the integrity of the product and packaging. This series of testing is summarized in the table below." (The provided table lists these tests, implying they were all successfully completed.)
Animal Testing (GLP)	Successful introduction of test devices, successful division of target fascial tissue, normal histopathology of surrounding tissues, no complications or deaths related to test articles/treatment, thermal characterization shows worst-case temperatures concentrated to cutting zone and limited duration.	"All test devices in the study were successfully introduced and the treatments successfully divided the target fascial tissue in the simulated carpal tunnel anatomy. Histopathology data was gathered on extracted tissues surrounding the target RF cutting regions and confirmed all tissues were normal. There were no complications or deaths associated with the test articles or treatment. Thermal characterization data showed that the highest temperature changes were immediately above the electrode confirming worst-case temperatures are concentrated to the cutting zone. Similarly, peak temperatures greater than 45°C were limited to the surgical electrodes and not significantly sustained."
Cadaver Testing (Usability Validation)	Absence of hazardous use errors during performance of critical tasks. No serious injury to the user or simulated patient. Successful division of TCL. No serious harm to simulated patient cadaver arms or surrounding tissue.	"The acceptance criteria for the usability validation testing are the absence of hazardous use errors during performance of critical tasks and that no serious injury to the user or simulated patient should occur during testing. The results demonstrated that the CarpX is safe and effective for the intended users, uses, and use environments. All use errors were absent during the performance of the critical tasks and no new errors were identified during testing. Finally, the TCL was successfully divided in all cases and no serious harm was observed in any of the simulated patient cadaver arms and no serious harm was observed to any of the surrounding tissue."
Cadaver Testing (Design Validation)	All acceptance criteria met for design validation requirements. Successful division of TCL. No serious harm to simulated patient cadaver arms or surrounding tissue.	"All acceptance criteria were met and all testing passed the design validation requirements. Additionally, the results showed that all users on all 15 procedures performed, were able to successfully divide the TCL and no serious harm was observed in any of the simulated patient cadaver arms or surrounding tissue."
Clinical Testing	No serious adverse events probably or definitely related to the device. All procedures completed successfully. All ligaments completely divided by endoscopic visual confirmation. Improved functional outcomes compared to baseline.	"No serious adverse event probably or definitely related to the device was observed through the 90-day follow-up period of the study. Most reported AEs were minor and expected. The secondary endpoint of the study was clinical device technical success, defined as the ability of the CarpX to perform complete division of the transverse carpel ligament as assessed by post-procedural endoscopic inspection of the TCL after treatment. All procedures in the study were completed successfully. All ligaments were judged by endoscopic visual confirmation to be completely divided at procedure conclusion. Functional outcomes were also improved at 90 days compared to baseline."

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

Animal Testing: 2 animals for the GLP study, 22 simulated carpal tunnel procedures. Data provenance: Conducted in compliance with FDA's Good Laboratory Practices (GLP), 21 CFR Part 58 (typically prospective for GLP).
Cadaver Testing (Comparative Use): 4 cadaver arms for CarpX and predicate endoscopic visualization, 1 cadaver arm for dimensional/spatial evaluation. Data provenance: Fresh or frozen fresh cadaver arms (retrospective, as they are not living subjects).
Cadaver Testing (Usability Validation): 5 surgeons, 23 simulated procedures. Data provenance: Human cadaver specimens (retrospective).
Cadaver Testing (Design Validation): 4 hand surgeons, 15 procedures. Data provenance: Patient cadaver arms (retrospective).
Clinical Testing: 20 patients enrolled, 19 subjects completed the 90-day follow-up. Data provenance: Single-center, non-blinded, single-arm study in New Zealand (prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Animal Testing: No specific number of experts mentioned for ground truth. Histopathology data was gathered, implying a pathologist's review, but qualifications are not stated.
Cadaver Testing (Comparative Use, Usability Validation, Design Validation):
- Usability Validation: 5 qualified intended users (surgeons, described as "hand surgeons" for design validation) performed the procedures and presumably assessed outcomes.
- Design Validation: 4 hand surgeons performed the procedures.
- Qualifications: "qualified intended users (e.g., hand surgeons)". Specific years of experience are not provided.
Clinical Testing:
- Two plastic surgeons performed the surgeries and assessed endoscopic visual confirmation.
- No specific number of independent experts were used to establish a separate ground truth. The surgeons performing the procedure made the assessment of TCT division.
- Qualifications: "Two plastic surgeons".

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1).
Clinical Testing: The assessment of complete division of the transverse carpal ligament was made by "endoscopic visual confirmation" by the performing surgeons. It doesn't specify if there was independent review or consensus-building if multiple surgeons were involved in the assessment for a single case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done to assess how much human readers improve with AI vs. without AI assistance. The CarpX is a surgical device, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. The CarpX is a surgical device used by a human surgeon. It is not an algorithm, and its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

Animal Testing: Histopathology data (pathology).
Cadaver Testing: Direct visual assessment (by surgeons) of TCL division, gross observation of surrounding tissue for harm, and absence of hazardous use errors (expert assessment/consensus).
Clinical Testing: Endoscopic visual confirmation (expert assessment) by the performing surgeons of complete TCL division, observation of adverse events, and functional outcomes data (patient-reported/clinical assessment).

8. The Sample Size for the Training Set

Not applicable. The CarpX is a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in the traditional sense. The development of the device would have involved iterative design and testing, but not a dataset for training an algorithm.

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

Not applicable, as there is no training set mentioned for this device.

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