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The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

The manufacturer tested the TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 for performance against the AAMI / ANSI SP10:2002 standard.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the performance and clinical test, nor does it provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The devices are blood pressure monitors and do not involve AI assistance for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This does not apply as the device is a sphygmomanometer, which is a hardware medical device for blood pressure measurement, not an algorithm. The "standing alone" performance would refer to the device's accuracy in measuring blood pressure against a reference method. The document states a clinical test was performed to AAMI/ANSI SP10:2002, which is a standard for automated sphygmomanometers, implying standalone performance was evaluated.

7. The type of ground truth used

For blood pressure monitors, the ground truth for clinical accuracy testing (such as that described by AAMI/ANSI SP10:2002) is typically established by simultaneous measurements using a clinically validated reference method (often a mercury sphygmomanometer or another auscultatory method performed by trained observers). The document does not explicitly state the specific ground truth method used, but compliance with AAMI/ANSI SP10:2002 implies such a method was utilized.

8. The sample size for the training set

This information is not applicable as the devices are hardware medical devices for blood pressure measurement and are not described as using machine learning models that require a training set in the context of this 510(k) summary.

9. How the ground truth for the training set was established

This information is not applicable (see point 8).

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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.

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).

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The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.

The device is a noninvasive blood pressure measurement system.

This document is a 510(k) premarket notification decision letter from the FDA regarding the TYTAN Professional/Economy Series Sphygmomanometer. It declares the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval letter, not a technical report or study summary. Therefore, I cannot complete the table or answer the specific questions requested.

The document only states the device's indications for use: "a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult."

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The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by Health Care Professional. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency.

This electronic Stethoscope is used for the amplification of of heart, lung and other body sounds. This Stethoscope has 3 modes for selective frequency amplification & a 8-steps volume control.

The Tytan Model #600 series Electronic Stethoscope does not include a study proving device performance against acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

Not applicable. The submission does not describe a clinical test set with human subjects or a dataset for evaluating an algorithm. The evidence presented focuses on bench testing and adherence to general safety and EMC standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable.

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 an electronic stethoscope; it is not an AI-powered diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical instrument for sound amplification, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth, in this context, would imply a reference standard for diagnostic accuracy, which is not evaluated. The "ground truth" for the performance claims appears to be adherence to recognized electrical and safety standards through bench testing.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

Not applicable.

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