(53 days)
The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.
The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a Dot-matrix LCD display, a semiconductor sensor, an internal air pump, a battery power or ac/dc power source, and keys for operation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K-jump Arm Blood Pressure Monitor, Model KP-7600 series:
Based on the provided snippets, the 510(k) submission for the K-jump Arm Blood Pressure Monitor, Model KP-7600 series, relies on conformity to established standards rather than a specific clinical study with detailed results for this particular device.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Blood Pressure Measurement Devices (based on ANSI/AAMI SP10:2002)
| Metric/Standard | Acceptance Criteria (ANSI/AAMI SP10:2002) | Reported Device Performance (KP-7600 series) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference (algorithm vs. reference): ≤ ± 5 mmHg | The device complies with ANSI/AAMI SP10:2002. Specific mean difference or standard deviation values for this device are not explicitly reported in the provided text. |
| Standard deviation of differences (algorithm vs. reference): ≤ 8 mmHg | ||
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) | The device complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2001 (Medical Electrical Equipment - EMC) | The device complies with IEC 60601-1-2:2001. |
Note: The provided text explicitly states that "This Arm BPM also complies with the electrical safety standards 60601-1 Medical Electrical Equipment- Part 1: General Requirements For Safety & 60601-1-2:2001 Medical Electrical Equipment- Part 1-2: General Requirements For Safety- Collateral Standard: Electromagnetic Compatibility-Requirements and Tests." and "In addition to the conformity standards, ANSI/AAMI SP10:2002 Manual, Electronic or Automated Sphygmomanometers, of the predicate device." While it states compliance, it does not provide the specific performance data (e.g., mean difference and standard deviation of differences for BP measurements) for the KP-7600 series against the ANSI/AAMI SP10:2002 criteria. It's implied that because it complies, it meets these thresholds.
2. Sample size used for the test set and the data provenance
The provided text does not explicitly state the sample size used for a test set for the KP-7600 series' blood pressure accuracy.
The data provenance (country of origin, retrospective/prospective) is also not specified for any performance study directly related to the KP-7600 series. The submission primarily references compliance with standards. It's possible that an internal verification was performed, but details are not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not provide information on the number or qualifications of experts used to establish ground truth. Since the submission relies on compliance with a standard (ANSI/AAMI SP10), the ground truth for such a standard is typically established by trained technicians following a specific protocol using auscultatory reference measurements performed by multiple observers, not necessarily "experts" in the clinical sense specified (e.g., radiologists, which are irrelevant for BP monitors).
4. Adjudication method for the test set
The provided text does not specify an adjudication method. For ANSI/AAMI SP10 compliance, the standard outlines specific consensus methods for obtaining reference blood pressure values, often involving simultaneous auscultation by multiple trained observers.
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, an MRMC comparative effectiveness study was not done or reported. This type of study is not relevant for a standalone blood pressure monitor, which is a measurement device, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, implicitly. The device is a "Blood Pressure Monitor," which functions as a standalone algorithm-only device in terms of generating the blood pressure measurement. Its performance is evaluated against a reference standard (e.g., auscultation). The direct measurement by the device (algorithm only) is what is assessed against the ANSI/AAMI SP10 standard.
7. The type of ground truth used
The ground truth used for verifying blood pressure accuracy in relation to the ANSI/AAMI SP10 standard is typically auscultatory reference measurements performed by trained observers. This involves a gold standard method where human observers listen for Korotkoff sounds to determine systolic and diastolic blood pressure.
8. The sample size for the training set
The provided text does not mention a training set sample size. Digital blood pressure monitors like this typically do not have a "training set" in the machine learning sense. Their algorithms are developed based on physiological principles and validated against reference methods. If iterative algorithm refinement occurred, the data used for that is not disclosed as a "training set" here.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" for the KP-7600 series in the machine learning context, the method for establishing its ground truth is not applicable/not provided. The device's algorithm development and validation would rely on established medical knowledge and comparisons to reference methods (like auscultation) as outlined in standards like ANSI/AAMI SP10.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).