(7 days)
Device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds
The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive sphygmomanometer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Blood Pressure Monitor Model HT-110:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a blood pressure cuff (Model HT-110). It does not contain a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for AI/ML devices. Instead, the submission relies on the device being "virtually the same" as predicate devices and meeting established industry standards for performance.
Therefore, many of the requested items (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission for a blood pressure cuff.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) (Implied: the device passed these tests and is safe and effective). | The Model HT-110 cuff is "virtually the same" as Critikon adult devices. |
| Biocompatibility same as predicate devices. | Biocompatibility is "same as predicate devices." |
| Repeated inflations and testing to ANSI/AAMI SP-9. | The device passed "Repeated inflations and testing to ANSI/AAMI SP-9." (This is the primary performance standard referenced, implying it met the criteria within that standard, though specific values are not given). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The submission mentions "Bench and laboratory testing" but does not detail the number of subjects or tests.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This device is a manual blood pressure cuff, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- Not applicable. This is a blood pressure cuff, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (blood pressure cuff), not an algorithm. Its operation involves manual inflation and a "manual method for detecting Korotkoff sounds."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the implied ground truth would be accepted reference measurements for blood pressure as defined by the ANSI/AAMI SP-9 standard. The standard itself would dictate the procedures for establishing accuracy.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of a training set.
Summary of the Study (as described in the 510(k) summary):
The submission describes bench and laboratory testing conducted to demonstrate the safety and effectiveness of the Nissei Blood Pressure Monitor Model HT-110. The core of the evidence relies on the device being "virtually the same as the Critikon adult devices" (predicate devices) and complying with the ANSI/AAMI SP-9 standard for blood pressure monitors. Biocompatibility was also asserted to be the same as the predicate devices.
The information provided is a concise summary aimed at demonstrating substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearances. It does not elaborate on the specific details of performance studies in the way a clinical trial report for a novel AI algorithm might.
§ 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).