(58 days)
The All Purpose Cuff is intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. They are not intended to be used on neonates. They are intended to be used with prescription (clinical grade) blood pressure monitors; they also could be used with Prescription Use X (Part 21 CFR 801 Subpart D) (AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
The All Purpose Cuff is an accessory for noninvasive blood pressure systems. It is comprised of a connector attached to tubing attached to an air tight bladder which is enclosed within an inelastic sleeve. The All Purpose Cuff comes in a range of sizes. Each is marked with the appropriate limb circumference for which the cuff is intended.
The provided text describes a 510(k) summary for the SunTech Medical All Purpose Cuff. However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document states that the device has been "tested to the applicable requirements" of various AAMI, EN, and IEC standards, and "These tests have indicated passing results." It also mentions a "Marketing Specification, (SunTech document # 97-0037-XX-FS), version 11," but the content of this specification is not provided.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
Here's a breakdown of what could be provided based on the very limited information, along with what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | "These tests have indicated passing results." (Specific values not provided) |
Missing Information: The document states testing was done according to AAMI SP10, EN1060, and IEC60601-2-30. These standards would contain specific performance criteria (e.g., accuracy, pressure stability, leak rates) for blood pressure cuffs, but the document does not enumerate them or report the specific numerical performance of the device against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information: The document does not specify any sample sizes for testing or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "These tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Missing Information: There is no mention of experts, ground truth establishment, or any human-based evaluation in the provided text. The testing appears to be primarily related to engineering and performance standards for the physical cuff itself.
4. Adjudication Method for the Test Set
Missing Information: Not applicable, as no expert evaluation or ground truth establishment process is described.
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
Missing Information: This device (All Purpose Cuff) is a physical blood pressure cuff, not an AI-powered diagnostic tool interpreting medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Missing Information: This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "standalone" performance would be its inherent physical performance characteristics as a cuff. The document states "These tests have indicated passing results" for various standards.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Missing Information: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus for image interpretation) is not explicitly discussed for this device. The "ground truth" for a blood pressure cuff's performance would be derived from physical measurements against calibrated references and adherence to engineering standards. The specific methods are not detailed beyond referencing AAMI, EN, and IEC standards.
8. The Sample Size for the Training Set
Missing Information: This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Missing Information: Not applicable, as there is no "training set" for this physical device.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).