(80 days)
The ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Please note that the provided text is a 510(k) Summary for a medical device (ArthroCare Electrosurgery Wands) seeking substantial equivalence to existing predicate devices. It is not a research paper detailing a study designed to establish acceptance criteria for an AI/ML device and demonstrate its performance against those criteria. Therefore, many of the requested points, particularly those related to AI/ML specific studies, expert ground truth, sample sizes for training/test sets, and comparative effectiveness studies, are not applicable or cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of indications for use, materials, technology, product specifications, energy requirements, and performance testing.
Here's an attempt to answer your questions based solely on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way an AI/ML study would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, and the "reported device performance" is summarized as being safe and effective for its intended use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use | Equivalent to predicate devices (K001302, K981361, K990947). Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. |
| Materials | Equivalent to predicate devices. |
| Technology | Equivalent to predicate devices. |
| Product Specifications | Equivalent to predicate devices. |
| Energy Requirements | Equivalent to predicate devices. |
| Safe and Effective Use | Demonstrated through performance testing for resection and ablation of soft tissue. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing," but does not provide any details about sample size (number of cases/patients), data provenance (country of origin), or whether the data was retrospective or prospective. It simply states "Performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The type of "ground truth" for a medical device like an electrosurgery wand usually involves established safety and performance benchmarks and clinical observable outcomes (e.g., successful tissue resection, coagulation, hemostasis) rather than expert labelling of data like in AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of performance testing described for an electrosurgical 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant to AI-assisted diagnostic or interpretative devices, which is not what the ArthroCare Electrosurgery Wands are. They are surgical tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ArthroCare Electrosurgery Wands are manual surgical tools, not AI/ML algorithms, and therefore do not have a standalone algorithm-only performance. They are used by a human surgeon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the "type of ground truth" in the way an AI/ML study would. However, for an electrosurgical device, the "ground truth" for proving safe and effective use would likely involve:
- Direct observable outcomes: Successful tissue resection, ablation, and coagulation; effective hemostasis.
- Pathology/Histology: Confirmation of tissue effects.
- Physiological measurements: E.g., temperature, current, power delivery.
- Adverse events: Absence of unintended tissue damage or complications.
The document refers to "performance testing" to demonstrate "safe and effective use," implying these types of objective measures were used.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set or ground truth for training.
{0}------------------------------------------------
OCT 2 5 2001
510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare® Electrosurgery Wands
| K012519 | ||
|---|---|---|
| General InformationManufacturer: | ArthroCare, Corporation595 North Pastoria AvenueSunnyvale, CA 94085-2936 | |
| Establishment Registration Number: | 2951580 | |
| Contact Person: | Bruce ProthroVice President Regulatory Affairs, QualityAssurance, and Clinical Research | |
| Date Prepared: | August 3, 2001 | |
| Device DescriptionClassification Name: | Electrosurgical Cutting and CoagulationDevice and Accessorics (21 CFR 878.4400) | |
| Trade Name: | ArthroCare® Electrosurgery Wand | |
| Generic/Common Name: | Electrosurgical Device and Accessories | |
| Predicate Devices | ||
| • ArthroCare Electrosurgery System | K001302 | |
| • Ethicon PowerStar Bipolar Scissors | K981361 | |
| • Coherent VersaPulse Select Single Wavelength (Ho:YAG) Dual |
- . Conerent Versuruise Sciect Single Wavelchigh |
Wavelcngth (Ho:YAG/Nd:YAG) Laser System ﺎ K990947
.
{1}------------------------------------------------
Intended Use
The Electrosurgery Wands arc indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
| General Surgery |
|---|
| • cholecystectomy |
| • lysis of adhesions |
| • upper Gl |
| • GI (other) |
| • splenectomy |
| • thyroidectomy |
| • herniorrhaphy |
| • breast biopsy |
| • bowel resection |
| • pelvic adhesiolysis |
| • removal of lesions |
| • removal of polyps |
| • tumor biopsy |
| Gynecological Surgery |
| • lysis of adhesions |
| • hysterectomy |
| • salpingo-oophorectomy |
| • burch colposuspension |
| • myomectomy |
| • endometriosis |
| • ovariohysterectomy |
| • removal of tumors |
Product Description
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Substantial Equivalence
In establishing substantial equivalence to the prodicate devices, ArthroCare evaluated the indications for use, materials, technology, product specifications, and energy requirements of those systems. Additionally, performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the prodicate devices, and are safe and effective for their intended use.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2001
Mr. Bruce Prothro Vice President Regulatory Affairs, Ouality Assurance and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085
Re: K012519
Trade/Device Name: ArthroCare® Electrosurgery Wand Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 3, 2001 Received: August 6, 2001
Dear Mr. Prothro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Mr. Bruce Prothro
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thison on your responsibilities under the Act may be obtained from the Oiner general mioninational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/3/Picture/5 description: The image shows a close-up of a handwritten symbol or character. It features a curved line that resembles a loop or a stylized letter. The stroke is thick and dark, suggesting it was written with a pen or marker. The overall impression is abstract and calligraphic.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications Statement
| Device Name: | ArthroCare® Electrosurgery Wands |
|---|---|
| 510(k) Number: | K012519 |
Indications for use:
The ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
| General Surgery | |
|---|---|
| • cholecystectomy | |
| • lysis of adhesions | |
| • upper GI | |
| • GI (other) | |
| • splenectomy | |
| • thyroidectomy | |
| • herniorrhaphy | |
| • breast biopsy | |
| • bowel resection | |
| • pelvic adhesiolysis | |
| • removal of lesions | |
| • removal of polyps | |
| • tumor biopsy | |
| Gynecological Surgery | |
| • lysis of adhesions | |
| • hysterectomy | |
| • salpingo-oophorectomy | |
| • burch colposuspension | |
| • myomectomy | |
| • endometriosis | |
| • ovariohysterectomy | |
| • removal of tumors |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Prescription Use (Per 21 CFR 801.109) OR
X
(Division Sign-Off)
Over-the-Counter Use
Division of ether, Restorative
and Neurological Devices
510(k) Number.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.