(13 days)
The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems.
Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:
Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)
Single Tube configuration with 6 types of connectors
Double Tube configuration with 2 types of connectors
The provided text describes the SURGI-CUF® REUSABLE Blood Pressure Cuffs, but it does not contain information about acceptance criteria, reported device performance, or a study involving AI or human readers. The document is a 510(k) summary for a medical device regulatory submission, focusing on establishing substantial equivalence to predicate devices primarily through physical characteristics and adherence to recognized standards for safety and effectiveness.
Therefore, I cannot fulfill your request for the specific details outlined, as those are not present in the provided text.
Here's what I can extract based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document states that performance was demonstrated per AAMI SP10:2002 and AAMI / ANSI / ISO 10993-1:2003(E) but does not list specific acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document mentions "Bench and laboratory testing" but does not provide details on sample sizes or data provenance.
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 available in the provided text. This type of information is relevant for studies involving diagnostic interpretation (e.g., imaging devices, AI algorithms), which is not the subject of this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided text. See point 3.
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 such study was done. This document is for a blood pressure cuff and does not involve AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available in the provided text. This document is for a physical medical device (blood pressure cuff), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available in the provided text. The performance was demonstrated against technical standards for blood pressure cuffs and biological evaluation, not against clinical ground truth in the manner of diagnostic algorithms.
8. The sample size for the training set
- Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI-driven system.
9. How the ground truth for the training set was established
- Not applicable/Not available in the provided text. See point 8.
Study described (bench and laboratory testing):
The substantial equivalence of the SURGI-CUF® REUSABLE Blood Pressure Cuffs was demonstrated through "Bench and laboratory testing" to conform to the following standards:
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers: This standard would address the performance characteristics of the blood pressure cuff itself, likely including aspects like accuracy of pressure transmission, durability, and functional integrity.
- AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices — Part 1: Evaluation and testing User Validation: This standard relates to the biocompatibility of the materials used in the device when in contact with the patient, ensuring it does not cause adverse biological reactions.
The document emphasizes that the device has "the same intended use and general construction" as its predicate devices, suggesting that the primary evidence for substantial equivalence relies on design similarity and compliance with recognized safety and performance standards for this type of device, rather than extensive clinical efficacy studies comparing it to a "ground truth" using complex metrics.
§ 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).