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Designed to apply controlled pressure to the leg to promote increased blood flow velocity. For use in prevention of deep vein thrombosis (DVT).

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The provided document is a 510(k) clearance letter from the FDA for the "Medline Anti-Embolism Stockings." This letter is a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing performance data against acceptance criteria for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. Specifically:

• No table of acceptance criteria and reported device performance is present.
• No information on sample size, data provenance, or number/qualifications of experts for ground truth is available, as this is not a clinical study report.
• No adjudication method is described.
• No details of a multi-reader multi-case (MRMC) comparative effectiveness study are provided.
• No information on standalone algorithm performance is included.
• No type of ground truth used is mentioned as it's not applicable to this regulatory clearance.
• No sample size for the training set or how ground truth for the training set was established is discussed.

The letter acknowledges the device's intended use: "Designed to apply controlled pressure to the leg to promote increased blood flow velocity. For use in prevention of deep vein thrombosis (DVT)." However, it does not provide performance metrics or studies to support these indications.

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Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery

Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration

Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical support stocking (Bellavar, Custom Seamless Soft). It confirms the device's substantial equivalence to a predicate device and lists its indications for use.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. These types of details are typically found in the 510(k) submission itself or in separate study reports, not in the clearance letter from the FDA.

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8-15 mmHg Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8
10-20 mmHg Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
15-20 mmHg Moderate Firm - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs - Helps prevent deep vein thrombosis for long distance travelers and edema
20-30 mmHg - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling - Helps prevent deep vein thrombosis for long distance travelers and edema
30-40 mmHg Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema - Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy

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This document is a 510(k) clearance letter for "Bossong Hosiery Medical Support Stockings." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information on acceptance criteria, a study proving device performance against those criteria, or any of the detailed study parameters requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The letter is a regulatory approval document and not a scientific study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided document.

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Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel. Over the counter use.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are made of a blend of nylon and spandex. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose provide graduated compression of the leg, with the higher compression in the ankle region and lower compression in the calf and the thigh (for the pantyhose only). Two compression ranges are available. Moderate. 15-20 mmHg. and Firm. 20-30mmHg. The compression hosiery products are produced on circular knitting machines. Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are substantially equivalent to the predicate products in product materials, mode of action, compression levels, function and indication for use, and as such, can be considered safe and effective as the referenced, predicate products. Like the products, the FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are available in a variety of colors and sizes for both men and women.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose differ from the predicate devices in the following aspects. Tsung Hau Technology Company, Limited, Shape to Fit, compression hosiery utilizes a "fresh weave odor control". The 3M FUTURO™ hosiery does not. Jobst's Travel Sock contains cotton yarn for comfort. The 3M FUTURO™ hosiery does not contain any cotton (with the exception of the cotton lined crotch in the pantyhose). No other significant differences are noted.

The provided 510(k) summary for the FUTURO™ Travel Knee-Highs, Socks, Stockings, and Pantyhose does not contain the information requested regarding acceptance criteria and a study proving device performance in the format of AI/ML software validation.

This is a medical support stocking, which is a physical device, not an AI/ML algorithm. The submission focuses on demonstrating substantial equivalence to predicate devices based on materials, mode of action, and compression levels, which are mechanical performance characteristics and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the type of device and submission described.

The summary states: "Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices." However, it does not provide the specific acceptance criteria or the detailed results of this performance testing.

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For the management of lymphedema and other edema.

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The provided text is a 510(k) premarket notification letter from the FDA for medical support stockings (Elvarex / Elvarex Soft / Elvarex Soft Seamless). This document does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/algorithm-based devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

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The Renfro Compression Socks are intended to help prevent pooling of blood in the legs by controlled pressure in the legs and help prevent deep vein thrombosis (DVT), edema and leg discomfort in individuals subjected to immobility

The Renfro Compression Socks are devices intended to help prevent pooling of blood and fluid to the extremities by applying controlled pressure. The Renfro compression socks are knitted using yarns made of nylon, polyester, cotton and spandex.

This is a 510(k) premarket notification for Renfro Compression Socks. This device is a Class II medical support stocking, and the submission establishes substantial equivalence to a predicate device rather than presenting a de novo performance study with acceptance criteria.

Therefore, the requested information elements related to standalone performance, MRMC studies, ground truth establishment, and test/training set details are not applicable in this context. The submission focuses on demonstrating that the new device has "similar physical and technical characteristics" to an already legally marketed device.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Note: The submission states that "All necessary performance testing has been conducted for the Renfro Compression Socks to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for compression strength or provide detailed results beyond stating that it was tested comparatively. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate.

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

• Not Applicable: This submission is for a medical support stocking, not a diagnostic or AI-driven device requiring a "test set" in the conventional sense of clinical data. The performance section mentions "test units representative of finished devices" for comparative compression strength, but does not provide a specific sample size or provenance for a clinical test set.

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

• Not Applicable: No clinical test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No clinical test set requiring adjudication was described.

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: No MRMC study was conducted as this is not an AI-assisted diagnostic device.

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

• Not Applicable: This is not a standalone algorithm; it is a physical medical device (compression socks).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable: The evaluation is based on technical characteristics and comparative physical performance, not on diagnostic ground truth.

8. The sample size for the training set

• Not Applicable: There is no training set mentioned, as this is a physical medical device, not a machine learning model.

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

• Not Applicable: No training set described.

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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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The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility.

15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time.

20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.

30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.

Not Found

The provided text is a 510(k) clearance letter for the Curad® Compression Hosiery. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device based on its indications for use.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a performance study with detailed acceptance criteria and results.

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The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.

The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by applying controlled pressure. The VenoTrain garments are flat knit using yarns made of nylon and spandex and then sewn together.

The provided text is a 510(k) summary for the VenoTrain curaflow medical support stocking. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria and study design are not present in the provided document. The 510(k) process for this type of device often relies on demonstrating that the new device has the same intended use and similar technological characteristics to legally marketed predicate devices, rather than requiring extensive clinical performance studies with defined acceptance criteria for a new clinical claim.

Here's an breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Not present in the document. The document states: "The safety and effectiveness of the VenoTrain curaflow is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device." It also states: "The VenoTrain curaflow is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics." This indicates that general principles of compression, rather than specific numerical acceptance criteria, are being used.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present. No specific test set or associated data is described, as the submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not present. No ground truth establishment is described for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not present. No test set or adjudication process is described.

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 medical support stocking, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not present. No ground truth is described for a performance study.

8. The sample size for the training set

• Not applicable/Not present. Training sets are typically for AI/machine learning models, which this device is not.

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

• Not applicable/Not present.

Summary based on the provided text:

The provided 510(k) summary focuses entirely on demonstrating substantial equivalence of the VenoTrain curaflow to existing predicate devices (Torbot Vascular Compression Garments (K061411) and Elvarex compression garments (K963573)).

• Acceptance Criteria/Performance Study: The document does not describe specific acceptance criteria or a study designed to prove the device meets them. Instead, the "acceptance" is based on the new device having the "same intended use and very similar technological characteristics" as the predicates.
• Intended Use: The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in the management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
• Technological Characteristics: The garments are flat knit using yarns made of nylon and spandex, and then sewn together, applying controlled pressure. This is deemed "very similar" to the predicates.

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