(32 days)
The ArthroCare Arthroscopic Electrosurgery System™ is a high frequency electrosurgical device intended for use in arthroscopic surgery to resect soft tissue and provide hemostasis.
The ArthroCare Arthroscopic Electrosurgery System™ is a high frequency electrosurgical device intended for use in arthroscopic surgery to resect soft tissue and provide hemostasis. The System is comprised of three components: the Multi-Electrode Probe, the Probe Cable, and the Controller. The bipolar design of the ArthroCare Probe incorporates the return electrode into the shaft of the device. This means that a patient ground pad is not required as with monopolar electrodes. The energy flows back to the Controller via the integral return electrode rather than through the patient's body to the return pad. In addition, the ArthroCare Probe is designed to be operated in a physiological saline environment while the predicate products must be operated in a non-conductive environment, such as sterile water or glycine.
This document describes a submission for expanding the indications of the ArthroCare Arthroscopic Electrosurgery System™ to include wrist arthroscopy. The original device was cleared for use in the knee, shoulder, ankle, and elbow.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a threshold for tissue resection depth). Instead, "acceptance criteria" are implied by the claim of safety and effectiveness for wrist arthroscopy, drawing parallels to its cleared use in other joints and the general advantages of arthroscopic surgery.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety in Wrist Arthroscopy | - No new safety issues anticipated compared to other joints. |
- Device used in over 10,000 arthroscopic procedures (all joints) with "no reports of compromised patient safety."
- Literature review suggests relatively few complications with wrist arthroscopy in general (incidence ~0.59%), and specific precautions can avoid most. |
| Effectiveness in Wrist Arthroscopy (Tissue Resection & Hemostasis) | - "Equivalent efficacy in tissue resection with less power requirements" compared to predicate devices in other joints (based on prior animal study). - Physicians reported the System is "effective in arthroscopic tissue ablation and hemostasis" in 10,000+ procedures (all joints).
- Wrist arthroscopy, in general, is documented in literature as an effective method for diagnostic and therapeutic interventions (e.g., ligamentous injuries, triangular fibrocartilage complex injuries, synovectomy). The device is positioned as an instrument for these established procedures. |
| Equivalence to Predicate Device (in general use, extending to wrist) | - Prior 510(k) demonstrated "no significant difference in the safety and efficacy of the ArthroCare Multi-Electrode Arthroscopy System and a standard monopolar electrosurgery device" in a goat study. This equivalence is implicitly carried over to wrist application. |
| Suitability for Small Joints (Wrist) | - "The smallest ArthroWand, sized at 2.5mm, is perfect for use in the wrist." |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set (for demonstrating new indication): There is no distinct "test set" or study specifically for the ArthroCare System's performance in the wrist. The argument relies on:
- Prior experience: Over 10,000 arthroscopic procedures (across various joints, provenance not specified, retrospective).
- Literature review: Numerous scientific articles discussing wrist arthroscopy in general (global provenance, retrospective). The specific numbers of patients in these literature examples (e.g., Cooney's 20 patients) refer to studies on wrist arthroscopy as a technique, not specifically the ArthroCare device.
- Prior Animal Study: A study comparing the device to a predicate (goats, in vivo, arthroscopic, prospective for K943450 clearance). The number of animals isn't explicitly stated but it evaluated meniscal tissue in intact joints.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- For the prior animal study: Not specified.
- For the 10,000+ procedures: "Physicians have reported." No details on the number or qualifications of these physicians establishing "ground truth" (i.e., effectiveness/safety). This is anecdotal feedback rather than a structured expert assessment.
- For the literature review: The quoted authors (Van Heest, Bain and Roth, Cooney, Bednar and Osterman, Savoie, Whipple, Buterbaugh, Warhold and Ruth) are presumed to be medical experts in orthopedics and arthroscopy, given they publish in scientific journals. Their expertise defines the general understanding of wrist arthroscopy.
4. Adjudication Method for the Test Set
- None specified. For the 10,000+ procedures, it seems to be self-reported physician feedback. For the literature review, it's a synthesis of findings from published experts, not a direct adjudication process for the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical instrument. "Standalone performance" would refer to the device's ability to resect tissue and provide hemostasis during surgery, which is inherently human-in-the-loop. The animal study assessed the device's physical effects on tissue, which is its "standalone" functionality in a controlled environment.
7. The Type of Ground Truth Used
- For the prior animal study: Direct measurement of "depth of tissue alteration and height and width of the ablation lesion" in goat meniscal tissue. This serves as a form of objective measurement for its physical effect.
- For the 10,000+ procedures: Physician reports on "effectiveness in arthroscopic tissue ablation and hemostasis" and "no reports of compromised patient safety." This is primarily clinical outcomes/user feedback.
- For the general arguments regarding wrist arthroscopy: Expert consensus and clinical outcomes data derived from the scientific literature.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware surgical device, not a machine learning model. There is no "training set" in the context of AI. The development and refinement of the device would have involved engineering and preclinical testing, but not in the sense of a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set. The "ground truth" for the device's design and performance parameters would have been established through engineering specifications, biomechanical testing, and preclinical (ex vivo/in vivo animal) studies conducted during its initial development and prior 510(k) clearance.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.