The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.

Device Description

This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.

AI/ML Overview

The prompt asks to describe the acceptance criteria and the study that proves the device meets them, based on the provided text. However, the provided text describes a "Wright Linear Pump" which is a sequential compression pump, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable to the given text.

Here's an analysis based on the provided information, noting where sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Functional / Performance:
Produces sequential compression	Produces sequential compression
Max pressure < 101 mm Hg	Factory-preset for a maximum pressure less than 101 mm Hg
Cell pressures reach prescribed setting 10+ seconds before next cell activated	Pressures in each cell reach the prescribed setting 10 or more seconds before the next cell is activated.
Maximum pressure in proximal cell sustained before end of cycle	Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
Disengage cells in quick succession (proximal to distal) ensuring no reverse gradient	Device disengages cells in quick succession, from proximal to distal, to ensure a reverse gradient is never applied despite any slight irregularities inherent in mechanical pneumatic systems.
Safety:
Complies with physician-prescribed treatment pressures	Complies with physician-prescribed treatment pressures
Addresses potential for "slight irregularities inherent in mechanical pneumatic systems"	Designed to disengage cells in a specific sequence to avoid reverse gradient despite slight irregularities.

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

Sample Size for Test Set: Not applicable in this context. The "test set" described relates to non-clinical technical testing of the prototype device's mechanical functions, not a dataset for an AI/ML model.
Data Provenance: Not applicable. The "data" refers to measurements from a prototype device's mechanical operation, not patient data or images.

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 AI/ML, refers to labels or diagnoses. Here, the "ground truth" for the non-clinical tests would have been the objective physical measurements themselves (e.g., pressure readings from precision regulators), not subjective expert assessment.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for resolving disagreements among multiple human experts establishing ground truth for AI/ML validation. This device's testing involved direct physical measurements.

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 is a mechanical medical device, not an AI-powered system designed to assist human readers (e.g., radiologists).

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

Not applicable. This is a mechanical device. The "standalone" performance here refers to the device operating according to its design specifications, without an AI algorithm.

7. The type of ground truth used

Non-clinical test data: The ground truth was based on objective physical measurements from precision regulators and observation of the device's mechanical operation (e.g., timing of cell engagement/disengagement, pressure readings).

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model that requires a training set. The "prototype device" was likely used for iterative design and testing, but not in the sense of an AI training set.

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

Not applicable. No AI training set.

Summary regarding the device and its testing based on the provided text:

The provided text details a mechanical sequential compression pump. The "study" described is a series of non-clinical tests conducted on a prototype device to verify its fundamental mechanical and pneumatic functions against design specifications. There are no mentions of clinical studies or any AI/ML components.

The device's performance was evaluated by directly measuring parameters like:

Cell pressures using separate precision regulators.
The timing of pressure activation and deactivation in different cells.
The maximum pressure achieved.

The acceptance criteria are implied by these measurements confirming the device operates as designed, particularly in ensuring sequential compression, preventing reverse gradients, and staying within pressure limits. The primary "proof" that the device meets these criteria comes from these direct, objective physical measurements on the prototype.

Summary

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K961299

NOV - 6 1996

510(k) Summary 4.

4.1. submitter

4.1.1. Wright Linear Pump, Inc. 303 Robinson Road Imperial, PA 15126
412 695-0800 FAX 412 695-0406
4.1.2. contact Edward J. Wright
4.1.3. prepared 04/06/96

4.2. product identification

4.2.1. trade name.............................................................................................................................................................
4.2.2. common name ....................... sequential compression pump
4.2.3. classification name Compressible Limb Sleeve (Class II) 21 CFR 870.5800
4.2.4. product number ................................................................................................. 74JQW

4.3. equivalence

4.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh / Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion sequential).
- 4.3.1.1. As a sequential pressure system, the proposed device is simpler than existing gradient pressure systems (Wright Linear Pump K830577B) for treating "simple lymphedema" or mild patient cases.

4.4. description

4.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity.
4.4.2. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.

4.5. intended use

4.5.1. The proposed device is to be used to improve the return circulation
03 April 1996 01996 Wright Linear Pump, Inc. 510k Submission -- Sequential Compression Therapy Device

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of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.

4.5.2. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.
4.5.3. Complies with physician-prescribed treatment pressures.
- section 513, 801(b), 52 Stat. 1055, 90 Stat. 540-546 (21 4.5.3.1. U.J.C. 360C 371(A)

4.6. technological characteristics

4.6.1. This device is a new state-of-the-art sequential compression pump/ and appliance system which produces better results than single-4 pressure systems currently in use.
- At end of the pressure phase of the treatment cycle, this 4.6.1.1. device disengages cells in quick succession, from proximal to distal, to ensure a reverse gradient is never applied despite any slight irregularities inherent in mechanical pneumatic systems. Cell C is disengaged just before cell B and, in turn. B iust before A.
4.6.2. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.

4.7. safety and effectiveness performance data

4.7.1. non-clinical test data
- 4.7.1.1. Cell pressures of prototype device were measured using separate precision regulators for each appliance cell.
- 4.7.1.2. Pressures in each cell reach the prescribed setting 10 or more seconds before the next cell is activated.
- 4.7.1.3. Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
4.7.2. clinical test data
- 4.7.2.1. not applicable

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).