as a cryosuraical tool for destruction of unwanted tissue in the fields . of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT;
to ablate prostatic tissue; .
for the ablation of prostatic tissue in cases of prostate cancer and . benian prostatic hyperplasia;
for ablation of cancerous or malignant tissue; .
for ablation of benign tumors; .
for palliative intervention; .
for ablation or freezing of skin cancers and other cutaneous . disorders;
for the ablation of malignant neoplasia or benign dysplasia of the . female genitalia;
for ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanaiomas, recurrent cancerous lesions;
for the destruction of warts or lesions: ●
for the palliation of tumors of the oral cavity, rectum, and skin;. .
for ablation of arrhythmic cardiac tissue; ●
. for the ablation of benign or malignant growths of the anus and rectum;
for the ablation of hemorrhoids; ●

Nitrous Oxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, general surgery, and urology;

Carbon Dioxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, and general surgery;

Argon and Krypton:

as a cryosurgical tool in general surgery, dermatology, neurology, . thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;

Device Description

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are simple, portable cryosurgical devices. All models feature physician-selected cryogen choices as well as a selection of cryoprobes of various sizes and shapes. Models 710, 711 and 712 are single cryoport devices while models 720, 721 and 722 have a two cryoport capacity. Although all models operate in the exact same way, their casings differ to allow desired positioning. The 710 and 720 are wheeled pole type configuration; the 711 and the 721 are tabletop configuration; while the 712 and the 722 are suitcase or attaché type configuration.

The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe having been placed in the appropriate position, then becomes cold and freezes the tissue.

AI/ML Overview

The provided 510(k) summary for the K980670 device (CMS Blizzard 700 Series) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for performance claims against pre-defined acceptance criteria, especially in the way an AI/ML device submission would.

The document primarily provides:

Device Description: What the device is and how it works (a cryosurgical unit designed to destroy unwanted tissue by applying cold).
Comparison to Predicate Devices: Detailed tables comparing features (cryogens, number of cryoprobes, cryogen containers, size, cryoprobe types, control) of the CMS Blizzard 700 Series to its own previous models (Cryo-lite™ System, AccuProbe® 600 Series) and competitor devices (Cabot Medical Cryomedics MT700, Erbe Erbokryo CA). This is the core of demonstrating substantial equivalence.
Indications for Use: A comprehensive list of medical applications for which the device is intended, varying by the cryogen selected.
FDA Correspondence: An FDA letter confirming substantial equivalence.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's a breakdown of why and what kind of information is missing, based on your request:

Table of Acceptance Criteria and Reported Device Performance: This document does not establish specific performance metrics (like accuracy, sensitivity, specificity) for the device. The "performance" being demonstrated is similarity in function and safety features to legally marketed predicate devices, not a quantitative performance score against a benchmark.
Sample Size used for the test set and data provenance: No test set is described. The approval is based on "substantial equivalence" to existing devices, inferring that if the predicate devices are safe and effective, and the new device is sufficiently similar, it also meets those standards.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for a test set is not mentioned as no performance study of this nature was conducted or reported.
Adjudication method: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study is specifically relevant for AI/ML devices assessing impact on human reader performance. The device here is a physical cryosurgical unit, not an AI diagnostic tool.
Standalone (algorithm-only) performance: Not applicable. The device is not an algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a traditional medical device (cryosurgical unit) submission for 510(k) clearance, which relies on demonstrating substantial equivalence to predicate devices. It does not involve the types of acceptance criteria, performance studies, or AI/ML specific data (training/test sets, ground truth, expert review) that your prompt is looking for.

Summary

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K980670

510(k) SUMMARY

February 20, 1998

Submitted by:

Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077

Contact:

Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Requiatory Affairs

Proprietary name: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722

Common name: Cryosurgical units and accessories

Cryosurgical units with Liquid Nitrogen, Nitrous Oxide, Carbon Classification: Dioxide. Class II, under CFR § 878.4350. Under CFR § 882.4250 a cryogenic surgical device also is classified in Class II.

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722 are similar in form and function to CMS's own Cryo-lite™ System, and its AccuProbe® 600 Series, as well as Cabot Medical's Cryomedics MT700 and the Erbe Erbokryo CA. For comparisons, please see below.

Page 1 of 5

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COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 AND THE CMS CRYO-LITE™ SERIES .

FEATURES	Cryo-liteTM Series(Tab G)	Blizzard 700 SeriesModels 710, 711, 712,720, 721and 722
Cryogens	Choice of liquid nitrogen,carbon dioxide, nitrous oxideand argon which may beused sequentially	Choice of liquid nitrogen,carbon dioxide, nitrous oxideargon or krypton which maybe used sequentially
Number ofCryoprobes	One cryoprobe	Models 710, 711 and 712have a one cryoprobecapacity while models 720,721 and 722 have a twocryoprobe capacity
Cryogen Containers	Cryogen packet and/ortransfer line to larger cryogensource	Cryogen packet and/ortransfer line to externalcryogen source
Size	Portable and Hand-held	Portable,- Table-top orwheeled stand
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Page 2 of 5

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COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND722 AND THE CMS ACCUPROBE® 600 SERIES

FEATURES	AccuProbe® Series(Tab. H)	Blizzard 700 SeriesModels 710, 711, 712,720, 721and 722
Cryogens	Liquid nitrogen	Choice of liquid nitrogen, carbon dioxide, nitrous oxide argon or krypton which may be used sequentially
Number ofCryoprobes	Depending on the model, from one to eight cryoprobe ports	Models 710, 711 and 712 have a one cryoprobe capacity while models 720, 721 and 722 have a two cryoprobe capacity
Cryogen Containers	Internal cryogen container	Cryogen packet and/or transfer line to external cryogen source
Size	Portable	Portable, - Table-top or wheeled stand
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Page 3 of 5

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COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720 ,721 AND 722 AND THE CABOT MEDICAL CYROMEDICS MT700

FEATURES	Cryomedics MT700(Tab I)	Blizzard 700 SeriesModels 710, 711, 712,720, 721 and 722
Cryogens	Choice of nitrous oxide andcarbon dioxide	Choice of liquid nitrogen,carbon dioxide, nitrousoxide, argon, or krypton
Number ofCryoprobes	One probe	Models 710, 711 and 712have a one cryoprobecapacity while models 720,721 and 722 have a twocryoprobe capacity
Cryogen Containers	Commercial CryogenContainer with Transfer Lineto Probe	Cryogen packet and/orTransfer Line to externalcryogen source
Size	Portable - Stand with wheelsand hand-held probe	Portable,- Table-top orwheeled stand with hand-held cryoprobe
Cryoprobes Types	Various, interchangeable	Various, interchangeable

Page 4 of 5

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COMPARISON OF FEATURES BETWEEN THE CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720 , 721 AND 722 AND THE ERBE ERBOKRYO CA

FEATURES	Erbokryo CA(Tab J)	Blizzard 700 SeriesModels 710, 711, 712,720, 721 and 722
Cryogens	Choice of nitrous oxide andcarbon dioxide	Choice of liquid nitrogen,carbon dioxide, nitrousoxide, argon, or krypton
Number ofCryoprobes	One probe	Models 710, 711 and 712have a one cryoprobecapacity while models 720,721 and 722 have a twocryoprobe capacity
Cryogen Containers	Commercial cryogencontainer with transfer line toprobe	Cryogen packet and/ortransfer line to larger cryogensource
Size	Portable - Stand with wheelsand hand-held Probe	Portable - Table-top orwheeled stand with and-held cryoprobe
Cryoprobes Types	Various, Interchangeable	Various, Interchangeable
Control	Foot switch	Console unit switch or footpedal

・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in all caps and is evenly spaced around the circle.

FEB 2 1 2008

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Cryomedical Sciences Inc. c/o Mr. Richard J. Reinhart, Ph.D. President and CEO 1300 Piccard Drive, Suite L105 Rockville, MD 20850

Re: K980670 Trade Name: CMS Blizzard 700 Series Models 710, 711, 712, 720, 721, 722 Regulatory Class: II (two) Product Code: OCL, GEH Dated: June 2, 1998 Received: June 2, 1998

Dear Dr. Reinhart

This letter corrects our substantially equivalent letter of July 17 1998.

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 (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 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.

{6}------------------------------------------------

Page 2 - Mr. Richard J. Reinhart, Ph.D.

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 (OS) 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 continue 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

ell. Mall.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

The CMS Blizzard 700 Series Models 710, 711, 712, 720, 721and 722, depending on the cryogen selected, are intended to be used:

Liquid Nitrogen:

as a cryosuraical tool for destruction of unwanted tissue in the fields . of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT;
to ablate prostatic tissue; .
for the ablation of prostatic tissue in cases of prostate cancer and . benian prostatic hyperplasia;
for ablation of cancerous or malignant tissue; .
for ablation of benign tumors; .
for palliative intervention; .
for ablation or freezing of skin cancers and other cutaneous . disorders;
for the ablation of malignant neoplasia or benign dysplasia of the . female genitalia;
for ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanaiomas, recurrent cancerous lesions;
for the destruction of warts or lesions: ●
for the palliation of tumors of the oral cavity, rectum, and skin;. .
for ablation of arrhythmic cardiac tissue; ●
. for the ablation of benign or malignant growths of the anus and rectum;
for the ablation of hemorrhoids; ●

Prescription Use
(Per 21 CFR 801.109)

Division Sian-Off) of General Restorative Device 510(k) Number

{8}------------------------------------------------

Indications for Use (continued)

Nitrous Oxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, general surgery, and urology;

Carbon Dioxide:

as a tool in the destruction of unwanted tissue in the fields of . dermatology, gynecology, and general surgery;

Argon and Krypton:

as a cryosurgical tool in general surgery, dermatology, neurology, . thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastases, skin lesions, warts and prostate tissue;
Prescription Use
(Per 21 CFR 801.109)

cale

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number ___ 196067

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.