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• Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy
• Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling
• Temporary decrease in blood circulation, where applied, . reduces pain and swelling.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the BREG, Inc. Polar Care 500 device. This document primarily focuses on regulatory approval and does not contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance studies.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document confirms the device's substantial equivalence to a predicate device and lists its indications for use, but it does not detail the specific performance studies that led to this determination.

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BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Breg, Inc. for their "E-Pain Care" device. This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the company to market the E-Pain Care device. It lists the device name, regulation number, regulatory class, and product code, and clarifies the "Indications for Use."

Therefore, I cannot extract the information asked for in your request from this document.

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The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.

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I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a medical device. The document is an FDA 510(k) clearance letter for a device called "Pain Care 4200," indicating that it has been found substantially equivalent to a predicate device.

The clearance letter primarily states:

• Device Name: Pain Care 4200
• Regulation Number: 880.5725 (Infusion Kit)
• Regulatory Class: II
• Product Code: MEB
• Indications For Use: To provide continuous infusion for post-operative management of pain.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given input.

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BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain.

The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

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Here is an analysis of the provided text regarding the Pain Care 3200 device, focusing on acceptance criteria and a study to prove its performance:

Based on the provided FDA 510(k) clearance letter (K013928) for the Breg Pain Care 3200, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The FDA letter is a substantial equivalence determination, meaning the device (Pain Care 3200) was deemed substantially equivalent to a legally marketed predicate device (Pain Care 3000) for its stated intended use. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often without requiring new standalone clinical studies against specific performance metrics outlined in your request.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a detailed technical study report.

To directly answer your prompt based on the absence of this information in the provided text:

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

   • Not Available: The provided document does not specify quantitative acceptance criteria or report performance metrics from a study for the Pain Care 3200. The clearance is based on substantial equivalence to the Pain Care 3000.

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

   • Not Available: The document does not describe a test set, sample size, or data provenance for performance evaluation.

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 Available: No ground truth establishment is described in relation to performance testing in this document.

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

   • Not Available: No test set or adjudication method 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 an infusion pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.

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

   • Not Available/Not Applicable: The Pain Care 3200 is an infusion pump, a medical device with mechanical and electronic components; it is not an algorithm, so standalone algorithm performance is not relevant. The substantial equivalence determination implies that its performance is equivalent to the predicate without requiring a new "standalone" study in the sense of an algorithm.

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

   • Not Available: As no performance study with a test set is described, no ground truth type is mentioned.

8. The sample size for the training set:

   • Not Applicable: This is an infusion pump, not a machine learning model, so there is no "training set."

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

   • Not Applicable: There is no training set for this device.

In summary, the provided FDA communication is a regulatory clearance document. While it indicates that the device has been cleared for market based on substantial equivalence, it does not include the detailed technical study information that your questions are looking for regarding acceptance criteria and performance studies. Such information would typically be found in a separate design validation report or a clinical investigation report, which are not part of this 510(k) summary letter.

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BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

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This document is a 510(k) clearance letter from the FDA for a device called "PAIN CARE 2000." This type of document typically grants market clearance based on substantial equivalence to a predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria.

While the letter confirms the device can be legally marketed, it does not contain the detailed information requested regarding acceptance criteria and performance study specifics. It primarily focuses on the regulatory determination of substantial equivalence.

Therefore, most of the information requested in your prompt (Table of acceptance criteria, sample sizes, ground truth details, MRMC study, standalone performance) is not present in the provided text.

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Ask a specific question about this device

Ask a specific question about this device