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510(k) Data Aggregation
(292 days)
The intended use of the Cuff Saver will be to cover all types of blood pressure cuffs and/or cuff bladders prior to the cuff or cuff bladder being applied to the patient. This will protect the patient and the health care worker from overt and covert exposure since blood pressure cuffs are often contaminated.
The Camouflage Cuff Saver is essentially a non woven paper drape that can cover/contain a reusable blood pressure cuff, a disposable cuff, or a cuff bladder. It is fluid repellent and acts to ensure a clean cuff for each patient as it is discarded after single patient use. It is manufactured of medical grade Sontara non woven fiber with 3M brand double sided adhesive tape as a fastening along one vertical edge of the unit and an adhesive patch located on the printed side of the unit. This patch is used to secure the device to its own surface after the device and the cuff it covers are applied to the patients arm. As stated, the device is printed with a design and typical marking for a blood pressure cuff (Artery placement, Range line, etc.). It is available on a perforated roll so that the user can tear off one unit at a time just as one removes a paper towel from its roll.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Camouflage Cuff Saver:
Acceptance Criteria and Device Performance
The document doesn't explicitly list a formal "acceptance criteria" table with pass/fail thresholds in the typical engineering sense. Instead, the performance is described in terms of equivalence to existing devices and absence of interference. The primary acceptance criterion appears to be that the Camouflage Cuff Saver does not alter the performance of standard blood pressure cuffs when used as a cover, and performs as well as a standard cuff when used with an inflation bladder.
Therefore, the table below reflects the reported device performance against the implicit acceptance criteria derived from the study's conclusions.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy (when used as a cover for reusable cuffs): No discernible or appreciable difference in blood pressure readings compared to conventional blood pressure cuffs without the Cuff Saver. | "The finding of the testing process showed no discernible or appreciable difference between the blood pressures taken with the conventional blood pressure cuffs and those fitted with the Camouflage Cuff Saver device." |
| Blood Pressure Measurement Accuracy (when used as a standalone cuff with inflation bladder): No discernible or appreciable difference in blood pressure readings compared to conventional blood pressure cuffs. | "There was also no appreciable or discernible difference between the blood pressures taken with the conventional cuff and those taken with the Camouflage Cuff Saver fitted with the standard inflation bladder." |
| Data Acceptance Limits: Conformance to the pass/fail criteria of a 95% Confidence interval of 4.3 or less. | "All of the measurements obtained to the data acceptance limits set forth in the testing protocol and all results conformed to the pass/fail criteria of a 95% Confidence interval of 4.3 or less derived from data collected from measurement of blood pressure taken with the calibrated Dinamap brand blood pressure machine and the two industry standard cuffs used in the study." |
| Biocompatibility: Materials used are biocompatible. | "Materials consist of DuPont Sontara FRO2 nonwoven fiber... and 3M brand No. 9890 Double Coated Medical tape... Both products are biocompatible according to the test information supplied by the respective companies. Both products are already in use in the medical industry." |
| Ink Information: Complies with national industry standards. | "Ink information is also supplied in the body of the notification and complies with national industry standards." |
| Infection Control (in terms of bacterial growth): Protected cuffs show "no growth" or 0 colony count compared to unprotected cuffs. (This is a separate "small culture study" and not the primary BP accuracy study). | "In our study, the cuff that was protected with our device during patient contact produced 'no growth 48 hrs' and a 0 colony count. This was not the case with the unprotected cuffs which all grew bacteria." (This refers to a "small culture study" by the company). |
| Compliance with AHA recommendations for cuff size and calibration: The cuff should be at least 40% as wide as the circumference of the limb for accuracy, and monthly calibration of manual sphygmomanometer units against an aneroid or mercury sphygmomanometer. | "The Camouflage Cuff Saver complies with these AHA recommendations." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 17 human volunteers of various sizes and upper arm circumference.
- Data Provenance: Retrospective, conducted by N. A. Braggs Medical, Inc. The country of origin is not explicitly stated but implied to be the US given the FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used to establish ground truth for the blood pressure measurements. However, the study mentions that "Measurement accuracy was confirmed by checking the Dinamap machine against pressure taken with a calibrated mercury sphygmomanometer." This implies the use of a calibrated and accepted reference measurement, which serves as the de-facto ground truth for blood pressure readings.
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Adjudication method for the test set:
- The document does not describe an explicit adjudication method for the test set measurements. The comparison was based on direct numerical readings from the Dinamap machine and the calibrated mercury sphygmomanometer.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it is a physical medical device (blood pressure cuff cover/disposable cuff).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical product, not an algorithm. The "standalone" performance in this context refers to its efficacy as a blood pressure cuff itself (when used with an inflation bladder), which was tested.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure measurement accuracy: The ground truth was established by comparison to a calibrated mercury sphygmomanometer, which is considered an industry standard for accurate blood pressure measurement.
- For infection control: The ground truth was bacterial culture results ("no growth 48 hrs" and "0 colony count") from a "small culture study."
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The sample size for the training set:
- This is not applicable as there is no "training set" in the context of a physical medical device. The device does not involve machine learning or AI that requires training data.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this physical medical device.
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