(207 days)
The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.
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 is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers
This submission describes a disposable blood pressure cuff. The relevant information related to acceptance criteria and performance studies is as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The device was tested against two recognized standards and an internal marketing specification. The submission states, "These tests have indicated passing results." However, specific numerical acceptance criteria and the detailed performance results for each criterion are not provided in this document.
| Acceptance Criteria Standard/Document | Reported Device Performance |
|---|---|
| AAMI SP10: 2002 | Passing results |
| IEC 60601-2-30:1999 | Passing results |
| Marketing Specification (SunTech document # 98-00162-XX-MS) | Passing results |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "The Disposable Blood Pressure Cuff has been tested to... standards and requirements."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of device and testing described. The device is a physical medical device (blood pressure cuff), and its performance is assessed against technical standards for accuracy and safety, rather than requiring expert interpretation for ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a physical device like a blood pressure cuff, performance is measured objectively against technical standards.
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
An MRMC comparative effectiveness study is not applicable as this device is a disposable blood pressure cuff, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified industry standards (AAMI SP10: 2002 and IEC 60601-2-30:1999) and an internal marketing specification. These standards define the acceptable range of accuracy for blood pressure measurements and other physical and safety features of the cuff. The device's performance is measured against these objective criteria.
8. The sample size for the training set
This information is not applicable. The development and testing of a physical blood pressure cuff do not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications, prototyping, and validation testing.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this device. The "ground truth" for general design and safety parameters would be established by relevant engineering principles, material science, and regulatory requirements that predate the specific device being developed.
§ 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).