(449 days)
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode. The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.
This document is a 510(k) premarket notification for a medical device, the "Single Use Arthroscopic Electrode (with Pencil)". It aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this regulatory submission.
However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the available information and a notation for what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a formal table of explicit acceptance criteria with quantitative targets and corresponding reported device performance. The performance testing section describes comparative testing between the subject device and the predicate device, aiming to show "substantially equivalent" thermal effect and tissue stickiness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Thermal effect on tissue (Cut mode) equivalent to predicate | Substantially equivalent thermal effect on porcine tissue (kidney, liver, muscle, bovine tendon) compared to predicate device. |
| Thermal effect on tissue (Coagulation mode) equivalent to predicate | Substantially equivalent thermal effect on porcine tissue (kidney, liver, muscle, bovine tendon) compared to predicate device. |
| Tissue stickiness on electrode tip (Cut mode) equivalent to predicate | Substantially equivalent tissue stickiness on electrode tip compared to predicate device. |
| Tissue stickiness on electrode tip (Coagulation mode) equivalent to predicate | Substantially equivalent tissue stickiness on electrode tip compared to predicate device. |
| Sterility | Validation and Verification testing performed in accordance with ISO 11135:2014. |
| Packaging integrity | Validation and Verification testing performed. |
| Electrical Safety | Complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC60601-2-2: 2009 (Fifth Ed). |
| Biocompatibility (Intracutaneous reactivity) | No biologically significant effect observed in tests conducted in accordance with ISO 10993. |
| Biocompatibility (in vitro cytotoxicity) | No biologically significant effect observed in tests conducted in accordance with ISO 10993. |
| Biocompatibility (Skin sensitization) | No biologically significant effect observed in tests conducted in accordance with ISO 10993. |
| Biocompatibility (Acute systemic toxicity) | No biologically significant effect observed in tests conducted in accordance with ISO 10993. |
| Biocompatibility (Pyrogenicity) | No biologically significant effect observed in tests conducted in accordance with ISO 10993. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for performance testing: Not specified. The document states "comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon". The number of samples for each tissue type or total samples is not provided.
- Data Provenance: The performance testing involved animal models (porcine tissue and bovine tendon). The country of origin of the data is not specified, but the manufacturing company is based in Hong Kong. The testing is retrospective in the sense that it was conducted as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing involved objective measurements of thermal effect and tissue stickiness rather than subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving subjective assessments (e.g., image interpretation), which is not the nature of the performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of AI in assisting human readers, which is not relevant for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical electrosurgical electrode, not an AI algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" was implicitly derived from direct observation and measurement of the biophysical effects (thermal effect and tissue stickiness) on the animal tissues under controlled experimental conditions. For sterility, packaging, electrical safety, and biocompatibility, the ground truth was established by adherence to and passing of specified international standards (ISO, IEC).
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 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.