(201 days)
The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The device is non-sterile and semidisposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.
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 noninvasive blood pressure measurement system.
The device is available in the following configurations:
- five neonatal and eight pediatric and adult sizes t
- single and dual cuff tubing, connectors, adapters and bulb/valve . assemblies available for use with a variety of manual and automated sphygmomanometers
The provided text describes the 510(k) summary for the CRITIKON Soft Blood Pressure Cuff, focusing on its substantial equivalence to previously marketed devices. The document details the device's description, technological characteristics, and performance testing, but it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria in the format requested.
The information primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device.
However, based on the provided text, here's an attempt to extract and infer information relevant to your request, acknowledging that explicit "acceptance criteria" and a detailed "study" demonstrating adherence to those criteria are not fully present for areas like accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for patient contact. | Bench and laboratory testing was conducted to demonstrate performance. (Specific results not detailed, but testing implies meeting safety standards.) |
| Reprocessing Validation: Instructions for reprocessing ensure the device remains safe and effective for limited reuse. | Validated according to a formal protocol (052496), comprising sound scientific principles and laboratory procedure. Conceptually based on AAMI TIR No. 12-1994. |
| Repeated Inflations: Device maintains integrity and function over repeated inflation cycles (for limited reuse). | Bench and laboratory testing was conducted to demonstrate performance. (Specific number of inflations or failure rate not detailed, but implies meeting durability standards.) |
| Blood Pressure Measurement Accuracy: (Inferred from device function, but not explicitly stated as an acceptance criterion for the cuff itself) | The cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The document does not provide data on the accuracy of blood pressure readings using this cuff, as that is typically evaluated for the measurement system as a whole. The substantial equivalence argument implies it performs similarly to predicate cuffs. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and laboratory testing" but does not specify sample sizes for these tests (e.g., number of cuffs tested for biocompatibility, reprocessing, or repeated inflations). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these tests are product performance evaluations rather than clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are engineering/laboratory tests (biocompatibility, reprocessing validation, repeated inflations) rather than clinical studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This is not applicable and not provided. The tests described are objective, laboratory-based performance tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or described for this device. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance might improve their performance. The CRITIKON Soft Blood Pressure Cuff is a physical medical accessory.
6. Standalone (Algorithm Only) Performance
A standalone performance study was not conducted or described. This device is a physical accessory and does not involve an algorithm.
7. Type of Ground Truth Used
For the described tests:
- Biocompatibility: Ground truth is established by recognized standards and laboratory protocols for material safety.
- Reprocessing Validation: Ground truth is established by adherence to a formal protocol (052496) conceptually based on AAMI TIR No. 12-1994, which details acceptable microbiological and material integrity outcomes after reprocessing cycles.
- Repeated Inflations: Ground truth is established by engineering specifications for durability and functional performance over a specified number of inflation cycles (though specific details are not provided).
8. Sample Size for the Training Set
This is not applicable and not provided. The CRITIKON Soft Blood Pressure Cuff is a hardware medical device and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not provided. As mentioned, there is no training set for this type of device.
§ 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).