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510(k) Data Aggregation
(48 days)
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.
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.
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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(7 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Facia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoidale Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Meniscectomy | Knee |
| Continued | |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
This is a 510(k) premarket notification for electrosurgical devices (ArthroCare® ArthroWands®). The document states that the proposed modifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices; therefore, no new studies were conducted. The device is found to be substantially equivalent to previously cleared predicate devices (K020557 and K033584).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or performance metrics derived from new testing are provided in this special 510(k). The basis for clearance is substantial equivalence to predicate devices. The document explicitly states: "The proposed modifications in the performance specifications, labeling, and packaging configuration are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Therefore, the "acceptance criteria" here is that the modified device's performance remains consistent with, and not significantly worse than, the predicate devices cleared under K020557 and K033584, for which presumably performance data would have been submitted at that time.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Performance specifications not significantly altered | Performance is consistent with predicate devices |
| Safety not significantly affected | Safety profile is consistent with predicate devices |
| Efficacy not significantly affected | Efficacy is consistent with predicate devices |
| Indications for Use remain the same | Indications for Use are identical to predicate devices |
| Technology remains the same | Technology is identical to predicate devices |
| Principle of operation remains the same | Principle of operation is identical to predicate devices |
| Sterilization parameters remain the same | Sterilization parameters are identical to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
No new test set was used for a study comparing the modified device's performance directly. This submission relies on the established performance of its predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new clinical or performance test set was evaluated.
4. Adjudication Method for the Test Set
Not applicable, as no new test set was evaluated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. The device is an electrosurgical tool, which typically undergoes performance testing (e.g., power output, tissue effects) rather than MRMC studies.
6. Standalone Performance Study (Algorithm Only)
No. This is a physical electrosurgical device, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable, as no new performance claims, clinical data, or "ground truth" establishment are presented for the modified device beyond its substantial equivalence to predicates.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device.
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