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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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