COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA by COSMAN MEDICAL, INC.

The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.

AI/ML Overview

Here's an analysis of the provided text regarding the Cosman RF Cannula, focusing on acceptance criteria and supporting studies:

Based on the provided 510(k) summary, the device is not an AI/ML powered device. This document describes a medical device, a radiofrequency cannula, and its substantial equivalence to predicate devices, focusing on physical and technical characteristics and bench testing. Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices, such as performance metrics like accuracy, sensitivity, specificity, and detailed study designs with ground truth establishment, are not applicable or not present in this type of submission.

The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving novel performance against predefined acceptance criteria for an AI algorithm.

Here's a breakdown based on your requested information, highlighting what is (and isn't) present in this particular 510(k) summary for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to predicate devices. This isn't quantified with specific performance metrics in the same way an AI/ML device would be, but rather through comparison of characteristics and functional testing.
- Functional Equivalence: The device must perform the same intended use as the predicate (RF heat lesion procedures for pain relief).
- Technical Equivalence: The device must have similar physical and technical characteristics (e.g., stainless steel cannula, insulated shaft, exposed tip, sterile, single-use, disposable, available in various lengths and gauges).

Reported Device Performance:

Performance Characteristic	Acceptance Criteria / Predicate Equivalence	Reported Device Performance (Cosman RF Cannula)
Intended Use	RF heat lesion procedures for pain relief	Indicated for use in RF heat lesion procedures for the relief of pain.
Physical Characteristics	Similar to predicate devices: Material (stainless steel), construction (insulated shaft, exposed tip), sterility (sterile, single-use, disposable), dimensions (various lengths and gauges).	"The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip... provided as a sterile, single use, disposable device. will be available in a variety of lengths and gauges."
Technical Characteristics	Similar to predicate devices (e.g., ability to deliver RF energy for lesion creation).	Used in conjunction with the Cosman RF Generator (K050084) to create RF lesions.
Safety & Effectiveness	Demonstrated by substantial equivalence to predicate devices and confirmed by non-clinical (bench) testing.	"Cosman Medical has done bench testing on the Cosman RF Cannula to confirm performance characteristics of this device." "The comparison to the predicate device demonstrates that the Cosman RF Cannula is safe and effective and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided: For this type of device (RF cannula), there isn't a "test set" of patient data in the way there would be for an AI/ML diagnostic or prognostic device. The testing mentioned is "bench testing" to confirm performance characteristics, which would involve physical samples of the device undergoing various engineering tests. The sample size for this bench testing is not specified. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: Given this is a physical medical device and not an AI/ML algorithm, there is no "ground truth" to be established by experts in the context of diagnostic performance. "Ground truth" for this device would relate to its physical properties and functional capability, confirmed through engineering tests.

4. Adjudication method for the test set

Not Applicable: No adjudication method is described because there is no "test set" of clinical cases requiring expert review or consensus for this device type. Adjudication methods like 2+1 or 3+1 are specific to AI diagnostic performance studies.

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, Not Applicable: An MRMC study is designed to evaluate AI assistance for human readers in diagnostic tasks. This device is an instrument used in a surgical/procedural context, not a diagnostic aid with an AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This device is a physical instrument, not an algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Engineering Specifications: For this device, the "ground truth" is its adherence to engineering specifications and its ability to function as intended (e.g., generate a specific RF lesion profile) as demonstrated through bench testing. It's not a clinical "ground truth" derived from patient data.

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: As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: The provided 510(k) pertains to a traditional, non-AI medical device (an RF cannula). The "study" referenced is "bench testing" to confirm performance characteristics and establish substantial equivalence to predicate devices, rather than a clinical trial or AI/ML performance study with specific acceptance criteria related to accuracy, sensitivity, etc. Therefore, most of your detailed questions regarding AI/ML study design are not applicable to this document.

Summary

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060799

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510(k) Summary of Safety and Effectiveness Information

MAY 2 2006

Company Information:	Cosman Medical, Inc.76 Cambridge St., Burlington MA 01803. USATel. 781-272-6561. Fax 781-272-6563Contact Name: Michael Arnold, Director of RA(781) 272-6561email: marnold@cosmancompany.comRegistration No.: 3004867882
Date Prepared:	April 28, 2006
Trade Names:	Cosman CSK RF CannulaCosman RFK RF Cannula
Common Name:	Radiofrequency Lesion Probes
Classification:	CFR 882.4725, Radiofrequency Lesion Probe,Class II Neurology Devices, Product Code: GXI
Predicate Devices:	LesionPoint RF Cannula (K053415)Neurotherm RF Cannula (K994344)Technomed Europe SMK Cannula (K042375)Cosman Medical RF Cannula & TC Electrodes(K050084)Smith & Nephew RF Cannula (K034012)Diros Facet Rhizotomy Electrode & Cannula(K010202)

Description: The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.

Intended Use: The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

Comparison to Predicate: The Cosman RF Cannula has similar physical and technical characteristics to the predicate devices.

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K060799

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Non-Clinical Data: Cosman Medical has done bench testing on the Cosman RF Cannula to confirm performance characteristics of this device.

Conclusion: The comparison to the predicate device demonstrates that the Cosman RF Cannula is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

COSMAN MEDICAL, INC.

Michael Arnold

Michael A. Arnold, PhD Director of Regulatory Affairs and Quality Assurance

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2006

Cosman Medical, Inc. c/o Mr. Michael Arnold Director of Regulatory Affairs 76 Cambridge Street Burlington, Massachusetts 01803

Re: K060799

Trade/Device Name: Cosman RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: March 22, 2006 Received: March 24, 2006

Dear Mr. Arnold:

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

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Page 2 - Mr. Michael Arnold

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. 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 marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko60799

Indications for Use

510(k) Number (if known):

Device Name: Cosman RF Cannula

Indications For Use:

" The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain. "

Prescription Use _ X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_Kolorifi

Cosman RF Cannula 510(k)

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).