The Wright Gradient 52 - Torso and Wright 51 - Torso consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances. It is typically used to compress upper and lower body extremities and portions of the torso.

The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential. opening and closing of the solenoid valves, which are connected to five (5) external pressure ports.

The appliance assembly is made of fabric and consists of one or two limb appliances (for an arm or a leg) and a torso appliance (for abdomen or chest area). Each limb appliance comprises four cells, with the dimensions of the appliance dependent upon the physician's order and the patient's limb measurements. There are two basic variations of the torso appliance: (1) a vest-like appliance for compression of the upper torso; and (2) a girdle-like appliance for compression of the lower torso. In each case the dimensions of the appliance dependent upon the physician's order and the patient's anatomical measurements.

In operation, the pump fills the inflatable appliance(s) with air to compress the prescribed limb(s) and torso area with the prescribed pressures in a preset therapy program. The therapy program is based on manual fymph drainage massage principles and intended to improve ymphatic and venous return circulation for the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright Gradient 52 - Torso and Wright 51 - Torso device.

Key Observation: The provided documentation is a 510(k) summary for a medical device that does not involve AI or imaging. It is a pneumatic compression pump. Therefore, many standard questions related to AI/imaging device studies (such as MRMC studies, ground truth establishment by experts for image interpretation, training/test set provenance, etc.) are not applicable to this device. The summary indicates that the device's performance was evaluated through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states a general adherence to performance specifications through bench testing.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Performance Verification	Conformity to performance specifications	"All tests were verified to meet acceptance criteria."
Sequences, Timing, Pressure	Measurements of sequences, timing, and pressure of therapy delivery	"Bench performance testing consisted of measurements of the sequences, timing, and pressure of therapy delivery... All tests were verified to meet acceptance criteria."
Operator Interface Functionality	Verification of functionality of the operator interface	"...along with verification of the functionality of the operator interface. All tests were verified to meet acceptance criteria."
Safety	As safe as the predicate devices	"Evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices."
Equivalence	Equivalent performance to predicate	"Bench performance testing was performed to verify equivalent performance."
Maximum Torso Pressure	Reduced to 30 mmHg (compared to predicate)	This is a design change, implicitly met through testing. The document doesn't state it failed this, so it implies it was met.

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

Sample Size: Not applicable in the traditional sense of a clinical trial or AI model testing with patient data. The testing described is bench testing of the device hardware and software. The document does not specify a "sample size" of devices or test cycles for the bench tests.
Data Provenance: Not applicable. The "data" comes from bench tests conducted on the device itself.

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

Not applicable. Ground truth, in the context of expert consensus, is typically for evaluating diagnostic accuracy or image interpretation. This device is a pneumatic pump, and its "ground truth" performance is a measure of its physical outputs (pressure, timing, sequences) against engineering specifications. Expert judgment for device functionality verification would be part of the quality assurance process, but not in the sense of establishing "ground truth" for a test set.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretations, primarily in diagnostic studies or when establishing ground truth from multiple human readers. This is a bench test on a physical 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

Not applicable. This device is a pneumatic compression pump, not an AI-powered diagnostic or imaging device that aids human readers.

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

Yes, in a sense. The "standalone" performance here refers to the device's ability to operate according to its specifications without human intervention during its operation. The bench testing evaluated the pump's performance (pressure, timing, sequences, operator interface functionality) in a "standalone" capacity against its design specifications and compared to the predicate device. However, this is not an "algorithm only" study in the context of AI.

7. The type of ground truth used

The "ground truth" for this device's evaluation is its engineering specifications and design requirements. The device is expected to deliver specific pressures, follow specific timing sequences, and have a functional operator interface. These predefined parameters are the "ground truth" against which its performance was measured during bench testing.

8. The sample size for the training set

Not applicable. This device does not use machine learning algorithms that require a "training set" of data.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, there is no ground truth establishment for a training set.

Summary

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K131387

510(k) Summary per 21 CFR 807.92 13.

Date Prepared

Submitter Information

May 10, 2013

Wright Therapy Products 103-B International Drive Oakdale, PA 15071-3907

NOV 20 2013

Telephone: 800-631-9535 Fax: 724-695-0406

Contact Person

Proprietery name of Device

Common Name:

Device Classification:

Predicate Device

Carol Wright, Chief Technology Officer

Wright Gradient 52 - Torso and Wright 51 -Torso

Pneumatic compression pump

21 CFR 870.5800, Class II, Sleeve, Limb, Compressible Product Code JOW

Wright 51 and 52 Sequential Compression System (K071040)

Device Description:

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Intended Use

Wright Gradient 52 - Torso and Wright 51 -- Torso is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.

Summary of technological characteristics compared to the predicate devices.

The Wright Gradient 52 -- Torso and Wright. 51 -- Torso has the following similarities to the technological characteristics of the previously cleared predicate device: Wright 51 and 52 Sequential Compression System, K071040):

. Same intended use
Same operating principle .
Same fundamental scientific technology ●
. Same pump design
Same materials used .
Similar appliance design .
Similar compression sequence .

The Wright Gradient 52 - Torso and Wright 51 - Torso has the following differences in technological characteristics of the previously cleared predicate device (Wright 51 and 52 Sequential Compression System, K071040):

The maximum pressure on the torso cell has been reduced to 30 mmHg. ●
The appliances have been changed to include torso appliances and 4-cell limb appliances. .
The inflation sequence has been revised. .
The software algorithm for inflation and deflation is revised to accurately control pressure . � during the variable therapy program and the unique geometry of the torso cells.

Summary of non-clinical testing submitted, referenced, or relied on in the 510(k)

The evaluation of the device consisted of risk analysis to confirm that the device is as safe as the predicate devices and bench tests to verify conformity to performance specifications. Bench performance testing consisted of measurements of the sequences, timing, and pressure of therapy delivery along with verification of the functionality of the operator interface. Bench performance testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.

Conclusion

Based on the above, we concluded that the Wright Gradient 52 -- Torso is substantially equivalent to the identified legally marketed predicate device, is safe and effective for its intended use, and performs as well as the predicate device.

End of section.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, featuring a staff with three wavy lines representing snakes.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2013

Wright Therapy Products Ms. Carol Wright Chief Technology Officer 103-B International Drive Oakdale, PA 15071-3907

Re: K131387

Trade/Device Name: Wright 51 - Torso Wright Gradient 52 - Torso Regulation Number: 21 CFR 870.5800 Regulation Name: Cardiovascular Regulatory Class: Class II Product Code: JOW Dated: August 21, 2013 Received: August 23, 2013

Dear Ms. Wright:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Carol Wright

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. EDWARDS

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

Enclosure

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CONFIDENTIAL

ર્. Indications for Use

5 l 0(k) Number (if known):

K131387

Device Name: Wright Gradient 52 - Torso and Wright 51 - Torso

Indications For Use:

Wright Gradient 52 - Torso and Wright 51 - Torso are for treatment of lymphedema, venous insufficiencies, and other edematous conditions.

Prescription Use _X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ﻌﺒﮧ ﻋ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MEDA

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Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).