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510(k) Data Aggregation
(115 days)
The FlexiPort EcoCuff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport EcoCuff blood pressure cuff is not designed, sold or intended for use, except as indicated.
This product is available for sale only upon the order of a physician or licensed health care professional.
The subject device has the same technological characteristics and indications for use as the predicate FlexiPort Blood Pressure Cuff. They both use the single port FlexiPort technology. They both are cuffs with an integrated bladder with a hook and loop closure system.
The subject device is made of polypropylene and has a slot feature in addition to the cuff range marker. The polypropylene is an economical material for use in a single patient use setting. The slot provides the clinician an additional means to correctly select the proper cuff size for the patient.
The provided text is a 510(k) summary for the Welch Allyn FlexiPort EcoCuff blood pressure cuff. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It explicitly states "Clinical Performance Data: Not Applicable". Therefore, the information requested regarding acceptance criteria, study details (sample size, ground truth, expert involvement, MRMC studies, standalone performance), and training set details for a clinical study cannot be extracted from this document, as such a study was not conducted or presented herein.
The document primarily relies on bench top testing and adherence to relevant standards to establish substantial equivalence.
Here's an attempt to address your request based only on the provided document, acknowledging the significant limitations due to the nature of the submission (non-clinical):
Acceptance Criteria and Study Details (Based on Provided Document)
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria with corresponding performance data from non-clinical tests. Instead, it states that "Bench top testing was conducted to ensure expected performance of the FlexiPort EcoCuff" [1]. The acceptance criteria are implicitly met by adherence to the performance requirements outlined in the listed standards for blood pressure cuffs.
| Acceptance Criteria (Inferred from Standards & Description) | Reported Device Performance |
|---|---|
| Material Properties: Suitable for single patient use, economical. | Made of polypropylene, described as an "economical material for use in a single patient use setting" [1]. |
| Functionality: Single port FlexiPort technology, integrated bladder, hook and loop closure. | Confirmed to have "the same technological characteristics" as the predicate device, including "single port FlexiPort technology" and "an integrated bladder with a hook and loop closure system" [1]. |
| Sizing Aid: Slot feature and cuff range marker for correct size selection. | Has a "slot feature in addition to the cuff range marker" which "provides the clinician an additional means to correctly select the proper cuff size for the patient" [1]. |
| Standard Compliance (e.g., Accuracy, Durability, Biocompatibility as per standards): | "The following standards were applied to the FlexiPort EcoCuff" [2]. Successful testing is implied by the conclusion of substantial equivalence. The specific test results (e.g., pressure retention, cycling durability, accuracy when used with a measurement system) are not provided in this summary. |
| ISO 10993-1 (Biological Evaluation) | Implied compliance by meeting the standard. |
| AAMI / ANSI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003 (Sphygmomanometers) | Implied compliance by meeting the standard. |
| ISTA 2A (Packaged-Products) | Implied compliance by meeting the standard. |
| EN 1060-1 (Non-invasive Sphygmomanometers-Part 1) | Implied compliance by meeting the standard. |
| EN 1060-2 (Non-invasive Sphygmomanometers - Part 2) | Implied compliance by meeting the standard. |
| ISO 14971 (Risk Management) | Implied compliance by meeting the standard. |
| ISO 81060-1 (Non Invasive Sphygmomanometers - Part 1) | Implied compliance by meeting the standard. |
| ISO 81060-2 (Non Invasive Sphygmomanometers-Part 2: Clinical Validation for Automated Measurement Type) | Although listed, the document states "Clinical Performance Data: Not Applicable", suggesting this standard's clinical validation section was deemed not applicable for this 510(k) submission, likely because cuff performance was assessed via bench tests and comparison to an already validated predicate. |
| Guidance Document: Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1 | Implied compliance by meeting the standard. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (number of cuffs tested) for the bench top non-clinical tests.
Data Provenance: Not specified, but standard bench testing would typically be performed in a laboratory setting. It is not patient data, so concepts like country of origin or retrospective/prospective do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical bench test. "Ground truth" in this context would refer to the standards themselves and objective measurements against those standards, not expert clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to clinical image interpretation or data review by multiple experts. The tests conducted were non-clinical bench tests.
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 device is a blood pressure cuff, not an AI-powered diagnostic tool. The submission explicitly states "Clinical Performance Data: Not Applicable" [2].
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive medical device (a cuff), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests would be the established specifications and performance requirements outlined in the listed industry standards (e.g., ISO, AAMI, EN). Performance was measured against these mechanical and material standards, not against clinical outcomes or expert consensus.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
Summary of Limitations:
This 510(k) summary explicitly states "Clinical Performance Data: Not Applicable." The regulatory pathway for this device (a blood pressure cuff) allowed for substantial equivalence to be demonstrated through non-clinical bench testing and comparison to a predicate device with similar technological characteristics. Therefore, the questions related to clinical study design, human readers, AI performance, ground truth establishment for clinical data, and training data are not addressed in this document because they were not part of the required submission for this type of device.
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