Search Results

To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.

The C.A.L.M. Sleeve is of circular knit construction, and is constructed from Nylon and Spandex yarns. The sleeve is intended to be worn on the arm, and covers the arm from wrist to 2" below the pivot point of the shoulder. The C.A.L.M. Sleeve is non-sterile, and is not intended to be sterilized in use. The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve. The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm.

The provided text is a 510(k) summary for the Albahealth C.A.L.M. Sleeve, a medical support stocking for the arm. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for AI/ML devices.

The K020592 submission for the Albahealth C.A.L.M. Sleeve, a gradient compression arm sleeve, predates the widespread use of AI/ML in medical devices and therefore does not include the detailed performance study information typically required for such devices today.

The document primarily focuses on:

• Device Description: Circular knit construction from Nylon and Spandex, graduated compression (20 to 30 mmHg at the wrist, decreasing towards the upper arm).
• Intended Use: To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.
• Substantial Equivalence: Claimed equivalence to Jobst Ready-to-Wear Arm Sleeve (K991570) and Juzo Expert Line Compression Arm Sleeve (K number unknown) based on similar compression levels and intended use.
• Safety Data: Search of FDA's MAUDE database did not reveal adverse events directly associated with compression arm sleeves, but identified 10 events associated with graduated compression products for the leg.
• Effectiveness Data: Mentions "articles documenting the benefits and effectiveness of compression garments in the treatment of edema and lymphedema" but does not provide details of any specific study conducted on this particular device. This is likely referring to general literature supporting the mechanism of action for such devices.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text because such information is not present within this 510(k) summary for this type of device.

To directly answer your request based on the provided text, without making assumptions:

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

   • Acceptance Criteria: Not explicitly stated in terms of performance metrics for this device. The primary "acceptance criteria" for this type of device at the time of this 510(k) would have focused on demonstrating substantial equivalence to predicate devices, particularly regarding compression levels. The reported compression level of "20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm" is stated.
   • Reported Device Performance: The device "yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm." This is presented as a characteristic of the device, not necessarily a performance metric against a predefined acceptance criterion from a specific study on this device.

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

   • Not applicable/Not provided. The document does not describe a performance study for this specific device.

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 provided. No performance study involving expert assessment is described.

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

   • Not applicable/Not provided.

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/Not provided. This type of study is not relevant to a compression arm sleeve.

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

   • Not applicable/Not provided. This device is not an algorithm.

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

   • Not applicable/Not provided.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is a physical product, not an AI/ML algorithm requiring a training set.

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

   • Not applicable/Not provided.

Ask a specific question about this device

The indications for use and the contraindication are listed separately in this application.

The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.

This appears to be a 510(k) summary for a medical device submitted to the FDA in 1996. The provided text describes the device and its intended use, but does not contain the information requested in your bullet points regarding acceptance criteria, study details, or performance data.

The summary describes the "albahealth PAS Wrap System," an inflatable leg wrap designed to prevent embolisms by alternately inflating and deflating to apply pressure to the calf. It mentions that the device is applied similarly to the "Jobst Athrombic Pump System 2000" and uses the "albahealth Pulsatile Anti-Embolism System pump" to deliver pressure. It also states that indications for use and contraindications are listed separately in the application and that "articles showing the benefits of this device and also MDR's and adverse experience reports" are summarized.

To answer your questions, I would need access to the full 510(k) submission, clinical study reports, or other documentation that details the performance testing and acceptance criteria. This summary only provides a high-level overview of the device and its predicate.

Ask a specific question about this device