Search Results

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and is indicated for use in the management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations.

The TRUFORM® Ready-To-Wear Compression Gauntlet is intended to be used to apply pressure to the hand and wrist and is indicated for use in the management of Lymphedema and other edema.

The TRUFORM® Ready-To-Wear Compression Arm Sleeve is circular knit with nylon and spandex yarns, is available in 3 sizes -- small, medium, and large, and is latex free, air-permeable and available in beige, black and brown.

The sizing of the TRUFORM® Ready-To-Wear Compression Arm Sleeve is based on circumferential measurements taken around the smallest part of the wrist, mid-lower arm, and around the mid-upper arm and is limited to individuals that fall within those specified ranges.

The TRUFORM® Ready-To-Wear Compression Gauntlet is circular knit with nylon and spandex yarns, is available in 3 sizes - small with compression of 15- 20 mmHg, medium with compression of 20-30 mmHg and large with compression of 20-30 mmHg. The thumb piece is sewn in place during a second operation. The TRUFORM® Ready-To-Wear Compression Gauntlet is latex free, air-permeable and available in beige, black and brown.

The sizing of the TRUFORM® Ready-To-Wear Compression Gauntlet is based on circumferential measurements taken around the palm and around the smallest part of the wrist, and is limited to individuals that fall within those specified ranges in sizing chart.

This document describes the TRUFORM® Ready-To-Wear Compression Arm Sleeve and TRUFORM® Ready-To-Wear Compression Gauntlet. The acceptance criteria and study detailed below focus on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics for a novel technology.

1. Table of Acceptance Criteria and Reported Device Performance

For the TRUFORM® Compression Arm Sleeve and Gauntlet, the primary acceptance criterion was substantial equivalence to their respective legally marketed predicate devices. This equivalence was assessed in terms of compression (mmHg) and user understanding/usability.

2. Sample Size Used for the Test Set and the Data Provenance

• Comparative Compression Bench Test: The sample size for this test is not explicitly stated in the provided document. It refers to comparing "Jobst predicate sleeves and TRUFORM® sleeves" and "Jobst predicate gauntlets and ТЯυFоям® gauntlets," implying multiple units were tested from each.

  • Provenance: The provenance of the data is not specified (e.g., country of origin). It appears to be an internal bench test conducted by Surgical Appliance Industries, Inc.
  • Retrospective/Prospective: As a bench test, it is inherently prospective in its data collection from the manufactured devices.

• Usability and Label Comprehension Study: The sample size for this study is not explicitly stated. It refers to "User studies conducted," but does not give a number of participants.

  • Provenance: The provenance of the data is not specified. It implies a general user study, likely conducted within the US given the FDA submission.
  • Retrospective/Prospective: This was a prospective study, directly involving users interacting with the device and its labeling.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the studies performed for this device.

• For the comparative compression bench test, the "ground truth" was established by objective compression measurements (mmHg) using standard methods, not expert interpretation.
• For the usability and label comprehension study, the "ground truth" was established by direct user responses and their ability to successfully use the product. Experts were not used for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable to the studies performed.

• The comparative compression test relied on quantitative measurements, not subjective interpretation requiring adjudication.
• The usability study relied on direct user feedback; any inconsistencies in responses would typically be analyzed rather than adjudicated by experts.

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

There was no MRMC comparative effectiveness study done. This device is a medical compression garment, not an AI-assisted diagnostic tool.

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

There was no standalone (algorithm only) performance study done. This device is a physical compression garment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Comparative Compression Bench Test: The ground truth was objective physical measurement of compression (mmHg). This is a direct physical property of the device, not based on expert consensus, pathology, or outcomes data.
• Usability and Label Comprehension Study: The ground truth was direct user feedback and observed user behavior demonstrating comprehension and proper usage.

8. The Sample Size for the Training Set

There was no "training set" in the context of an AI/machine learning model, as this device is a physical product and not an AI-driven system.

9. How the Ground Truth for the Training Set was Established

As there was no training set for an AI/machine learning model, this question is not applicable.

Ask a specific question about this device