(70 days)
The ArthroCare Arthroscopic Electrosurgery System™ is a high frequency electrosurqical device intended for use in arthroscopic surgery to resect soft tissue and provide hemostasis.
The ArthroCare Arthroscopic Electrosurgery System™ is a high frequency electrosurqical device intended for use in arthroscopic surgery to resect soft tissue and provide hemostasis. The System is comprised of three components: the Multi-Electrode Wand, the Wand Cable, and the Controller. The bipolar design of the ArthroCare Wand 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 enerqy 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 Wand is designed to be operated in a physiological saline environment while the predicate products must be operated in a nonconductive environment, such as sterile water or glycine.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ArthroCare Arthroscopic Electrosurgery System™ for hip arthroscopy, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" in a quantified, pre-defined manner. Instead, it presents the results of a clinical dataset and argues for the device's acceptable performance based on these outcomes, considering patient demographics and the nature of the condition.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain or improve patient condition | 59% of patients improved, 39% had no change |
| Safety Profile | No reports of compromised patient safety in over 5,000 arthroscopic procedures (across various joints, including hip use post-clearance). |
| Efficacy in tissue ablation and hemostasis | Physicians reported the System is effective in arthroscopic tissue ablation and hemostasis (across various joints). |
| Delay need for total hip replacement (especially in younger, arthritic patients) | A 59% improvement rate is considered acceptable, as the procedure offers a potential method for delaying more invasive surgeries. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 199 hip arthroscopy procedures performed on 177 patients.
- Data Provenance: Retrospective – The data was compiled by a physician from their clinical database of patients treated via hip arthroscopy between March 1984 and February 1996. The country of origin is not explicitly stated but is implied to be within the US given the FDA submission context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One physician.
- Qualifications: "A physician with considerable experience performing this procedure." No specific years of experience or board certifications are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: None. The data represents a single physician's assessment of outcomes from their clinical practice. It was not a controlled study with independent adjudication.
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
- MRMC Study: No, an MRMC study was not done. This submission pertains to a surgical electrosurgical system, not an AI-assisted diagnostic or interpretative device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The device is a surgical instrument and inherently requires human-in-the-loop operation. This concept does not apply to this type of medical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Physician-reported clinical outcomes ("Improved," "Worse," "No Change") based on their assessment of patient status post-procedure.
8. The Sample Size for the Training Set
- Sample Size:
- Human Clinical Data: 199 hip arthroscopy procedures on 177 patients (same as the "test set" as this is the primary clinical evidence presented for hip arthroscopy).
- Animal Study: Not specified, but an "in vivo, arthroscopic animal study" was conducted (goats) to compare tissue alteration. This study supported the original 510(k) for the device (K943450) for other joints.
- Prior Clinical Experience: Over 5,000 arthroscopic procedures (across various joints) prior to this submission.
9. How the Ground Truth for the Training Set Was Established
- Human Clinical Data (Hip Arthroscopy): The ground truth was established by a single practicing physician, who categorized outcomes as "improved," "worse," or "no change" based on their clinical judgment of patients in their database.
- Animal Study: The ground truth was established by comparing the "depth of tissue alteration and height and width of the ablation lesion" between the ArthroCare System and a standard monopolar electrosurgery device in goat meniscal tissue. This was likely assessed by researchers/veterinarians involved in the study.
- Prior Clinical Experience: "Physicians reported that the System is effective in arthroscopic tissue ablation and hemostasis." This suggests informal clinician feedback and observational data over time, not a formally established ground truth in the typical study sense.
§ 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.