(155 days)
Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should connected to a Non Invasive Blood Pressure Monitor to complete the function. There is various sizes for different arm range as follows:
| Model | Arm range |
|---|---|
| KD-525-P31 | 20cm-34cm |
| KD-525-P32 | 30cm-44cm |
| KD-525-P33 | 40cm-48cm |
| KD-525-P34 | 15cm-24cm |
| KD-5917-P42 | 22cm-42cm |
Here's an analysis of the provided text regarding the acceptance criteria and study for the Andon Blood Pressure Cuff:
Acceptance Criteria and Device Performance
The provided text for the Andon Blood Pressure Cuff (K133117) states that "the device met all applicable requirements of the standard" for its clinical tests. However, it does not explicitly provide a table of specific numerical acceptance criteria and the reported device performance against those criteria. Instead, it refers to compliance with standards.
Here's a breakdown of the information available:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| IEC 80601-2-30 (Clinical Test) | Met all applicable requirements of the standard. |
| IEC 80601-2-30 (Non-clinical Test) | Safety and performance characteristics tested. No new questions of safety/effectiveness raised. |
| ISO 10993-1, ISO 10993-5, ISO 10993-10 | Biocompatibility tests performed and conform to standards. No new questions of safety/effectiveness raised. |
Study Details
2. Sample size used for the test set and data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical test has been done in accordance with IEC 80601-2-30...". IEC 80601-2-30 Section 201.12.1.101 (Clinical investigation of AUTOMATED SPHYGMOMANOMETERS) typically specifies a minimum of 85 subjects for accuracy evaluation. Without the full standard report, the exact number used in this specific study cannot be determined from the provided text.
- Data Provenance: Not explicitly stated. It's not mentioned whether the data was from a specific country or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- This information is not provided in the given text. For blood pressure cuff validation according to standards like IEC 80601-2-30, ground truth is typically established by trained observers (auscultation method) using a reference sphygmomanometer, but the number and qualifications of such observers are not detailed here.
4. Adjudication method for the test set
- This information is not provided in the given text.
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
- No MRMC comparative effectiveness study was done or mentioned. This device is a blood pressure cuff, a passive medical device, not an AI-powered diagnostic tool that human readers would interact with.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was conducted implicitly. The clinical and non-clinical tests, particularly the clinical test in accordance with IEC 80601-2-30, evaluate the device's performance (i.e., its ability to measure blood pressure) as a standalone component when used with an NIBP monitor. The "algorithm" here refers to the cuff's physical characteristics and how it interfaces with the NIBP monitor to facilitate the measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on the reference to IEC 80601-2-30, the ground truth for blood pressure measurement studies typically involves:
- Simultaneous auscultation: Trained observers (experts) using a mercury sphygmomanometer or another validated reference device on the opposite arm or using a Y-connector with a reference device. This method provides the reference systolic and diastolic blood pressure values.
8. The sample size for the training set
- Not applicable/Not provided. This device is a blood pressure cuff, not an AI/machine learning model that would require a distinct "training set." The tests performed are for validation of the physical device's performance against established standards.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As explained above, a training set associated with ground truth is not relevant for this type of device and its validation.
§ 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).