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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.

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Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions: Edema Lymphedema Hypertrophic scars

While the JUZO Gauntlet is flat knit and sewn together from fabric made of spandex, viscose and nylon yarns, the JOBST Ready-To-Wear Gauntlet is circular knit with spandex and nylon yarns. The thumb piece is then sewn in place in a second operation. Both products are available in two compression ranges, 20-30 mmHg and 30-40 mmHq. the compression ranges most often prescribed by physicians for the indications involved. Both products are sized based on the palm and wrist measurements. Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic absorption.

The provided text describes a 510(k) submission for a medical device, the Jobst Ready-To-Wear Gauntlet. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria related to device performance in a clinical setting.

Therefore, the requested information pertaining to acceptance criteria and a study proving those criteria are met for a diagnostic AI device (which would involve performance metrics like sensitivity, specificity, etc.) is not applicable to this submission. This is a low-risk device (medical support stockings) where the primary concerns are biocompatibility and mechanical equivalence to an existing product.

Here's why each point you asked for is not relevant or cannot be extracted from the provided text for this specific device:

1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance metrics like accuracy, sensitivity, or specificity. The "performance" is primarily defined by providing compression in a specific range and being biocompatible.
2. Sample size used for the test set and the data provenance: Not applicable for a performance study. The only "test" mentioned is a biocompatibility test on rabbits, which is not a clinical performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as there is no clinical performance study in the AI sense.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For the biocompatibility test, the "ground truth" was the observation of skin irritation on rabbits.
8. The sample size for the training set: Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Provided Text (regarding equivalence and testing):

• Device Name: Jobst Ready-To-Wear Gauntlet
• Predicate Device: JUZO Gauntlet
• Indications for Use: Edema, Lymphedema, Hypertrophic scars (same as predicate)
• Mode of Action: Gradient compression provided by elastic yarns, helps reduce capillary leakage and improve capillary and lymphatic absorption (same as predicate).
• Materials: Spandex and Nylon (similar to predicate, JUZO Gauntlet uses spandex, viscose, and nylon; JOBST uses spandex and nylon). The materials are also the same fibers used in other previously cleared Jobst products (K925154, K920444, K991570).
• Compression Ranges: 20-30 mmHg and 30-40 mmHg (same as predicate).
• Sizing: Based on palm and wrist measurements (same as predicate).
• Manufacturing Difference: JUZO Gauntlet is flat knit and sewn; JOBST Gauntlet is circular knit with a sewn-in thumb piece. This difference is deemed not to affect substantial equivalence.

Biocompatibility Testing:

• Test Performed: Fastox Primary Skin Irritation test.
• Tested Product: Samples of UltraSheer stockings (which use the same fibers and dyes as the RTW Gauntlet).
• Test Subject: Three rabbits per test.
• Observation Intervals: 24, 48, and 72-hour intervals.
• Results: No evidence of any skin irritation.
• Conclusion: Unlikely that use of the Jobst RTW Gauntlet will result in significant skin irritation.

Overall Conclusion of the Submission:
The Jobst Ready-To-Wear Gauntlet is substantially equivalent to the predicate product (JUZO Gauntlet) in materials used, mode of action, and indications for use, and is considered safe and effective. The biocompatibility data from a similar product supports its safety.

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