(29 days)
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
Here's a breakdown of the acceptance criteria and study information for the Statcorp Medical UltraCheck® Spacelabs ABP Cuffs, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document specifically refers to clinical accuracy testing performed "per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)." While the table below summarizes the core requirements of this standard, the document does not explicitly state the numerical acceptance criteria met by the device for each specific requirement. Instead, it generally concludes that the device performed per the methodology and requirements.
| Acceptance Criteria (Based on AAMI ANSI ISO 81060-2 (2013) - General Requirements) | Reported Device Performance |
|---|---|
| Criterion 1: Mean difference between the test device and reference measurement for systolic blood pressure (SBP) ≤ ±5 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 2: Standard deviation of the differences for SBP ≤ 8 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 3: Mean difference between the test device and reference measurement for diastolic blood pressure (DBP) ≤ ±5 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 4: Standard deviation of the differences for DBP ≤ 8 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 5 (Additional Mechanical Tests): Pressure cycle testing to 10,000 cycles for life validation. | Met (validated life). |
| Criterion 6 (Additional Mechanical Tests): Application testing to 1,000 cycles for life validation. | Met (validated life). |
| Criterion 7 (Additional Mechanical Tests): Mechanical stress testing for ring durability. | Met (validated ring durability). |
| Criterion 8 (Additional Mechanical Tests): Cleaning validation tests for cleaning recommendations. | Met (validated cleaning recommendations). |
| Criterion 9 (Additional Mechanical Tests): Label integrity testing for chemical resistance and legibility. | Met (validated label chemical resistance and legibility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample size (number of subjects/measurements) used for the clinical accuracy testing. AAMI ANSI ISO 81060-2 (2013) typically recommends a minimum of 85 subjects for validation studies.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide this information. For blood pressure cuff validation, ground truth is typically established by trained technicians using a reference device (e.g., mercurial sphygmomanometer with a stethoscope) following a strict protocol.
4. Adjudication Method for the Test Set:
The document does not provide this information. For blood pressure cuff validation, adjudication (e.g., by two independent observers measuring simultaneously) is often part of the AAMI standard's methodology.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No, an MRMC comparative effectiveness study was not performed.
- Effect Size of Human Readers with/without AI: Not applicable, as this is a medical device (blood pressure cuff) and not an AI-assisted diagnostic tool for image or data interpretation.
6. Standalone (Algorithm Only) Performance:
- Was it done?: Yes, in essence, the clinical accuracy testing performed per AAMI ANSI ISO 81060-2 (2013) is a standalone performance evaluation of the device in its intended use. The device (cuff) is being tested for its ability to accurately measure blood pressure.
7. Type of Ground Truth Used:
For the clinical accuracy testing, the ground truth would be reference blood pressure measurements obtained simultaneously using a validated and calibrated reference device (e.g., a mercurial sphygmomanometer with auscultation by trained observers), as per the AAMI ANSI ISO 81060-2 standard.
8. Sample Size for the Training Set:
Not applicable. This device is a blood pressure cuff, which does not employ machine learning or AI algorithms requiring a "training set" in the conventional sense. Its function is based on mechanical properties and calibrated pressure readings.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this 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).