Search Results

The BODYTRONIC 200 is a photoelectric plethysmograph intended for the measurement of the leg vein function.

The BODYTRONIC 200 is based on light reflection rheography. A small quantity of infrared light is radiated into the legs just above the ankles, and the reflected light is measured. On the basis of the quantity of reflected light over a defined period, conclusions can be drawn about the flow of blood in the veins.

The provided text describes the 510(k) Premarket Notification for the Bauerfeind BODYTRONIC 200, a photoelectric plethysmograph. However, it does not contain any information about acceptance criteria, device performance metrics, or experimental studies performed to prove the device meets specific acceptance criteria.

The document focuses on establishing substantial equivalence to a predicate device (Elcat vasoquant VQ1000 D-PPG) based on intended use and technological characteristics, and compliance with various international standards related to electrical safety, EMC, usability, software life-cycle, risk management, biocompatibility, and photobiological safety.

Therefore, I cannot provide the requested information from the given text. The text primarily details:

• Device Description: The BODYTRONIC 200 uses light reflection rheography to measure blood flow in leg veins.
• Intended Use: Measurement of leg vein function.
• Predicate Device: Elcat vasoquant VQ1000 D-PPG (K944395).
• Regulatory Information: Classification as Class II, Product Code JOM, under 21 CFR 870.2780.
• Standards Compliance: Listing of various IEC and ISO standards the device complies with.
• FDA Premarket Notification Outcome: FDA's determination of substantial equivalence.

Without a study report or performance data, I cannot fill out the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies.

Ask a specific question about this device

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.

Ask a specific question about this device