The C.A.L.M. Sleeve is of circular knit construction, and is constructed from Nylon and Spandex yarns. The sleeve is intended to be worn on the arm, and covers the arm from wrist to 2" below the pivot point of the shoulder. The C.A.L.M. Sleeve is non-sterile, and is not intended to be sterilized in use. The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve. The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm.

AI/ML Overview

The provided text is a 510(k) summary for the Albahealth C.A.L.M. Sleeve, a medical support stocking for the arm. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML devices.

The K020592 submission for the Albahealth C.A.L.M. Sleeve, a gradient compression arm sleeve, predates the widespread use of AI/ML in medical devices and therefore does not include the detailed performance study information typically required for such devices today.

The document primarily focuses on:

Device Description: Circular knit construction from Nylon and Spandex, graduated compression (20 to 30 mmHg at the wrist, decreasing towards the upper arm).
Intended Use: To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.
Substantial Equivalence: Claimed equivalence to Jobst Ready-to-Wear Arm Sleeve (K991570) and Juzo Expert Line Compression Arm Sleeve (K number unknown) based on similar compression levels and intended use.
Safety Data: Search of FDA's MAUDE database did not reveal adverse events directly associated with compression arm sleeves, but identified 10 events associated with graduated compression products for the leg.
Effectiveness Data: Mentions "articles documenting the benefits and effectiveness of compression garments in the treatment of edema and lymphedema" but does not provide details of any specific study conducted on this particular device. This is likely referring to general literature supporting the mechanism of action for such devices.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text because such information is not present within this 510(k) summary for this type of device.

To directly answer your request based on the provided text, without making assumptions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics for this device. The primary "acceptance criteria" for this type of device at the time of this 510(k) would have focused on demonstrating substantial equivalence to predicate devices, particularly regarding compression levels. The reported compression level of "20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm" is stated.
- Reported Device Performance: The device "yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm." This is presented as a characteristic of the device, not necessarily a performance metric against a predefined acceptance criterion from a specific study on this device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The document does not describe a performance study for this specific device.
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):
- Not applicable/Not provided. No performance study involving expert assessment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- Not applicable/Not provided. This type of study is not relevant to a compression arm sleeve.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
The sample size for the training set:
- Not applicable/Not provided. This device is a physical product, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary

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K020592

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Alba-Waldensian, Inc. 425 North Gateway Ave. Rockwood. TN 37854 Telephone: (865) 354-5209 Fax: (865) 354-1541 Contact Person: David Bowman, Technical Director Date Prepared: February 15, 2002

APR 0 3 2002

The following is a summary of safety and effectiveness for:

Proprietary Name: albahealth C.A.L.M. Sleeve

Common/Usual name: Gradient Compression Arm Sleeve

Classification Name: Stocking, Medical Support (per 880.5780)

The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve.

The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm. This is the same level of compression claimed for the Jobst Ready-to-Wear Arm Sleeve (510(k) #K991570) and the Juzo Expert Line Compression Arm Sleeve (510(k) # unknown). This gradient compression helps keep fluid from accumulating in the arm in cases of edema and lymphedema of the arm, and assists in maintenance of the size of the limb in patients undergoing treatment for these conditions.

Search of FDA's MAUDE database did not reveal any adverse events associated with compression arm sleeves. Search of the database under product code DWL identified 10 events associated with graduated compression products (such as anti-embolism and support stockings) designed for use on the leg. Summaries of these 10 adverse events are attached.

Also attached are articles documenting the benefits and effectiveness of compression garments in the treatment of edema and lymphedema.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Bowman Technical Director Alba-Waldensian, Incorporated Healthcare Products Division 425 North Gateway Avenue Rockwood, Tennessee 37854

APR 0 3 2002

Re: K020592

Trade/Device Name: Albahealth C.A.L.M. Sleeve, Model 59001 Regulation Number: 880.5780 Regulation Name: Gradient Compression Arm Sleeve Regulatory Class: II Product Code: DWL Dated: February 15, 2002 Received: February 22, 2002

Dear Mr. Bowman:

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

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Page 2 - Mr. Bowman

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Tir othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K020592

Statement of Indications for Use

Albahealth C.A.L.M. Sleeve - Catalog #59001 Gradient Compression Arm Sleeve

Indications:

To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.

Patricia Cucente

ivision Sign-Off) ision of Dental, Infection Control, Ceneral Hospital Devices 205 Ale 00 Humber __

Regulation Number and Section

§ 880.5780 Medical support stocking.

(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.