(50 days)
The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.
The TYTAN 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 TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes. Each cuff will be packaged in a polyethylene bag.
The acceptance criteria, study details, and ground truth establishment for the Tytan Blood Pressure Cuff are derived from the provided 510(k) summary (K062238).
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used
The Tytan Blood Pressure Cuff sought substantial equivalence to a predicate device (TRICOT BLOOD PRESSURE CUFF, K0515339) by demonstrating equivalent functional and physical performance characteristics. The primary ground truth for evaluating performance was the ANSI/AAMI SP9:1994 standard.
| Acceptance Criteria (Based on AAMI SP9:1994 Standard) | Reported Device Performance (Tytan Blood Pressure Cuff) |
|---|---|
| Functional Performance - Dimension | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Pressure Capacity | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Cuff Closure | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Biocompatibility (for new outer material) | Passed three Biocompatibility tests, considered substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical "sample size" in terms of number of cuffs tested for the performance evaluations. Instead, it states that "The TYTAN blood pressure cuff was compared to the TRICOT blood pressure cuff to confirm its functional and physical performance characteristics were equivalent." This implies a comparative testing methodology was used.
The data provenance is prospective testing conducted by the manufacturer for the purpose of demonstrating substantial equivalence. The country of origin for the device's manufacturer is Taiwan, but the testing details (where, by whom) are not specified beyond the reference to the AAMI standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The ground truth for performance was established by the ANSI/AAMI SP9:1994 standard itself, which is a published consensus standard. The process of developing such a standard typically involves numerous experts in the field, but this document does not detail their involvement in this specific submission. The manufacturer performed tests to show adherence to this standard.
4. Adjudication Method for the Test Set
This information is not provided. Given that the evaluation was based on compliance with a specific engineering standard (AAMI SP9:1994), an "adjudication method" in the sense of expert review committees is unlikely for these technical performance attributes. Compliance would typically be determined by meeting predefined thresholds and specifications outlined in the standard.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is a critical component. For a blood pressure cuff, the performance evaluation focuses on physical and functional characteristics, not human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was implicitly done. The "performance data" section describes the evaluation of the cuff's characteristics (dimension, pressure capacity, cuff closure, biocompatibility) based on the AAMI SP9:1994 standard. This testing focuses solely on the device's intrinsic physical and functional properties, independent of human interaction during the measurement process, beyond proper training of personnel for its use.
8. The Sample Size for the Training Set
This concept is not applicable to this device. Blood pressure cuffs are mechanical devices, not AI/algorithm-driven systems that require "training sets" in the conventional machine learning sense. The "study" for this device involved physical and functional testing against a standard, not training a predictive model.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable (see point 8).
§ 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).