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Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.

AR-1.0, AR-2.0is combined with leg, foot, garments. Leg garment has four air chambers operated by STEP3 controller and foot has one air chamber operated by STEP1. STEP3 controls a leg garment compressing sequentially in order of foot, calf and thigh and then injecting fresh air inside a leg garment through holes of garment to prevent from generating sweat by long wear of a garment.

The provided text is a 510(k) Summary for a medical device called "Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)". It is a submission to the FDA for market clearance, arguing for substantial equivalence to predicate devices.

Based on the provided text, the device did not undergo a clinical study or performance study to prove it meets specific acceptance criteria based on human or algorithm performance metrics. The submission argues for substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices.

Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, or human improvement with AI assistance) cannot be answered directly from this document because such a study was explicitly not performed.

Here's a breakdown of the information that can be extracted and an explanation of why other requested information is not present:

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

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are related to demonstrating substantial equivalence through adherence to recognized standards for safety and electrical performance, and through a comparative analysis against predicate devices. The implicit acceptance criterion is that the device is "as safe and effective" as the legally marketed predicates.
• Reported Device Performance: The "performance" reported is primarily in terms of compliance with non-clinical standards and the comparison of technical specifications to predicate devices. No specific diagnostic accuracy or AI performance metrics are reported.

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

• Not applicable. The document explicitly states: "No clinical study is included in this submission." Therefore, there is no "test set" in the sense of patient data for evaluating diagnostic or intervention performance. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility).

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. As no clinical study was performed, there was no test set requiring expert-established ground truth.

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

• Not applicable. No clinical study or test set for performance evaluation was conducted.

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 "Powered Inflatable Tube Massager," not an AI-powered diagnostic or AI-assisted interpretation device. The submission explicitly states no clinical study was done, and therefore no MRMC study.

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

• Not applicable. This is a physical device (massager), not an algorithm or AI system.

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

• Not applicable. No clinical study or performance evaluation requiring ground truth data was performed. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set.

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UAM-8100 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Compressible Limb Therapy System UAM-8100

This document, a 510(k) clearance letter for the Compressible Limb Therapy System UAM-8100, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The letter primarily:

• Confirms that the FDA has reviewed the 510(k) premarket notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Outlines post-market regulatory requirements (e.g., registration, labeling, adverse event reporting).
• Provides the "Indications for Use" for the device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter is a clearance for marketing, not a detailed technical report of performance.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain this type of information, one would typically need to review the actual 510(k) submission document itself, which contains the detailed technical and clinical study data submitted to the FDA for review. The letter provided is the FDA's decision based on that submission.

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The Hygia West Reprocessed Compression Garments operate in the identical manner as the predicate devices. They are designed for the prevention of deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insulficiency. The devices are used in both the home and institutional settings.

The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to:

• Prevent deep vein thrombosis and resulting pulmonary embolism .
• Intra-operative compression therapy

The Llygia West Reprocessed Compression Garments are intermittent compressible limb devices that are placed around cither the patient's foot (with the compression chamber placed under the plantar arch), calf (gastrocnemius muscle), thigh, or a combination there of. The garments are constructed from materials that are common to the medical device industry. Depending on the type of device, the method of fastening to the patient may vary from a hook and loop closure system to a uni-body style that is slipped over the limb. In foot compression devices, as the garment compresses the plantar plexus, the veins collapse longitudinally; this action causes an increase in the venous pressure thus eiceting the blood upward. After compression, the devices deflate allowing the veins to refill bringing oxygenared blood to the lower limbs. In devices used on the calf or thigh the compression to the area causes the blood to be ejected upwards to the heart, as the compression relaxes the valves in the veins close allowing them to refill. This cyclical method removes deoxygenated or stale blood from the region allowing fresh blood to be received. On all devices the controller predetermines the inflation and deflation sequence. The operational characteristics such as the pressure of compression, hold time, and inflation time are determined by the controller. It is the responsibility of the end user to ensure that the device is connected to an approved controller and to ensure that the controller settings are accurate. Hygia West does not repair, refurhish, or reprocess the controlling unit. Hygia West guarantees 100% of our devices ONLY if it has heen connected to an approved, functional, and correctly adjusted controller.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hygia West Reprocessed Compression Garments:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the acceptance criteria implicitly through the concept of "substantial equivalence" to predicate devices. The study aims to demonstrate that the reprocessed devices perform identically to the original devices.

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

• Sample Size for Test Set: The document mentions "Comparative bench testing was utilized" and "a NTH level combination irritation/sensitization human skin patch test was conducted." However, no specific numerical sample sizes are provided for either the bench testing or the human skin patch test. The "NTH level" for the skin patch test is unclear without further context.
• Data Provenance: The data is generated by Hygia West, Inc. as part of their 510(k) submission. It represents prospective testing conducted by the manufacturer to demonstrate substantial equivalence for their reprocessed devices. The country of origin for the data is implicitly the USA, where Hygia West, Inc. is based and where the regulatory submission is made to the FDA.

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

• Number of Experts: The document does not specify the number of experts used for establishing ground truth, nor does it detail any expert involvement in the testing process beyond the general statement of "testing was utilized."
• Qualifications of Experts: Not provided.

4. Adjudication Method for the Test Set:

• The document does not describe any adjudication method for the test set. The tests mentioned appear to be objective performance and biocompatibility tests rather than assessments requiring human adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• No, an MRMC comparative effectiveness study was not done. The device in question is a reprocessed compression garment, and the studies performed are bench tests and a human skin patch test, not studies involving human readers interpreting medical cases. Therefore, there is no mention of "human readers" or "AI assistance."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This question is not applicable to the device described. The Hygia West Reprocessed Compression Garments are physical medical devices (compressible limb sleeves), not an AI algorithm or software. The "performance" refers to the physical function of the garment, not an algorithm's output.

7. The Type of Ground Truth Used:

• For functional performance, the ground truth appears to be the performance characteristics of the original, new predicate devices. The reprocessed devices are compared against these known, established performance metrics.
• For biocompatibility, the ground truth is established based on accepted standards for human skin irritation and sensitization, as evaluated by the "NTH level combination irritation/sensitization human skin patch test."
• For intended use and technological characteristics, the ground truth is the stated and established properties of the predicate devices.

8. The Sample Size for the Training Set:

• This question is not applicable, as the device is a reprocessed physical medical device, not an AI algorithm or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the same reason as point 8.

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The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.

The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.

The provided text describes a 510(k) premarket notification for a reprocessed compressible limb sleeve. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often seen for novel devices or software.

Here's an analysis based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Comparative bench testing," which implies a sample was used, but the size of this sample is not provided.
• Data Provenance: The study was "conducted at Medical Device Services, Inc." It appears to be a bench test conducted by the manufacturer, rather than a clinical study with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the way they would be for patient-centric studies.

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

• Not Applicable. This submission describes bench testing for a physical medical device (a reprocessed limb sleeve), not a diagnostic algorithm that requires expert interpretation for ground truth. The "ground truth" here would relate to the functional and safety specifications of the device itself, likely assessed through engineering tests and measurements.

4. Adjudication Method for the Test Set

• Not Applicable. As this is bench testing and not an expert-based ground truth establishment, adjudication methods like 2+1 or 3+1 are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI-powered diagnostic device, and therefore, an MRMC study is not applicable. The device is a reprocessed compressible limb sleeve.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This is not an algorithm, so standalone performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this comparative bench testing would be the functional and safety specifications of the original new device (Kendall Model 6325 SCD Sequential Compression System). The reprocessed devices were tested against how the original, new devices are expected to perform. This likely involved quantitative measurements of parameters like inflation pressure, cycle times, air leakage, material integrity, and biocompatibility (though the latter isn't explicitly detailed in the summary).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

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