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The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.

The FAST Sphyg by Koven is an aneroid sphygmomanometer that uses the auscultatory blood pressure technique in combination with a stethoscope or Doppler and occluding cuff to determine systolic and diastolic blood pressure measurement. The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.

The provided text describes the FAST Sphyg by Koven, an aneroid sphygmomanometer intended for indirect measurement of arterial blood pressure. The document focuses on establishing substantial equivalence to a predicate device and adherence to relevant performance standards.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

   The document does not present a single, consolidated table explicitly labeled "acceptance criteria" and "reported device performance" in the context of clinical accuracy for blood pressure measurement. Instead, it refers to compliance with performance standards, primarily ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.

   However, the document lists other technical standards that the device meets, which can be considered acceptance criteria for electrical safety and electromagnetic compatibility:

   Standard / Test	Acceptance Criteria / Test Level	Reported Device Performance / Compliance Level
   ISO 81060-1:2007	Requirements and test methods for non-automated measurement type	Designed and tested to meet this standard. (Specific accuracy metrics not detailed in this excerpt)
   IEC 60601-1 (2007) - Electrical Safety	Class II device (Protection class against electric shock)	Class II device, Internally powered equipment
   	Type B applied part (Protection grade against electric shock)	Type B applied part
   IEC 60601-1-2 (2007) - Electromagnetic Emissions
   RF Emissions CISPR 11	Group 1	Group 1
   RF Emissions CISPR 11	Class B	Class B
   Harmonic Emissions IEC 61000-3-2	Class A	Class A
   Flicker Emissions IEC 61000-3-3	Not Applicable	Not Applicable
   IEC 60601-1-2 (2007) - Electromagnetic Immunity
   Electrostatic Discharge (ESD) IEC 61000-4-2	±6kV Contact, ±8kV Air	±6kV Contact, ±8kV Air
   Electrical Fast Transient/burst IEC 61000-4-4	±2kV for power supply lines, ±1kV for input/output lines	±2kV for power supply lines, ±1kV for input/output lines
   Surge IEC 61000-4-5	±1kV differential mode, ±2kV common mode	±1kV differential mode, ±2kV common mode
   Voltage dips, short interruptions, and variations	< 5% UT for 0.5 cycles, 40% UT for 5 cycles, 70% UT for 25 cycles, < 5% UT for 5 s	< 5% UT for 0.5 cycles, 40% UT for 5 cycles, 70% UT for 25 cycles, < 5% UT for 5 s
   Power frequency (50/60 Hz) magnetic field	3 A/m	3 A/m
   Conducted RF IEC 61000-4-6	3 Vrms (150 kHz to 80 MHz)	3 Vrms
   Radiated RF IEC 61000-4-3	3 V/m (80 MHz to 2.5 GHz)	3 V/m

   For the primary function of blood pressure measurement accuracy, the document states, "the FAST Sphyg has been designed and tested to meet the following standards: ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type." However, the specific accuracy acceptance criteria defined within ISO 81060-1 (e.g., mean difference and standard deviation between the device and reference method) and the actual reported performance data against these criteria are not detailed in this excerpt.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   This information is not provided in the excerpt. The document states that the device was "designed and tested to meet" ISO 81060-1:2007, but it does not describe the specific study, patient cohort, or sample size used for that testing.

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):

   This information is not provided in the excerpt. For blood pressure measurement, the "ground truth" would typically come from a trained observer using a reference sphygmomanometer (e.g., mercurial sphygmomanometer or direct arterial measurement) following specific protocols, often involving multiple observers to mitigate bias (as per ISO standard requirements). However, no details on this are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   This information is not provided in the excerpt. Given that the device is a sphygmomanometer, adjudication would refer to how multiple measurements or observations by reference methods are reconciled, if 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:

   This is not applicable to the FAST Sphyg by Koven. This device is a mechanical aneroid sphygmomanometer with a battery-powered pump, not an AI-assisted diagnostic tool for image analysis or interpretation.

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

   This is not applicable to the FAST Sphyg by Koven. It is a manually operated device where a healthcare provider uses a stethoscope or Doppler to interpret the Korotkoff sounds. There is no "algorithm" in the sense of an automated analytical process that provides a standalone reading without human involvement in the detection of sounds.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   For blood pressure measurement devices, the ground truth is typically established by simultaneous measurements using a recognized reference method, such as a mercurial sphygmomanometer or direct invasive arterial pressure measurement, performed by trained observers. The document, however, does not explicitly state the specific "type of ground truth" used in its testing beyond mentioning compliance with ISO 81060-1:2007, which dictates such methods.

8. The sample size for the training set:

   This information is not applicable/not provided. As an analog medical device (aneroid sphygmomanometer), the FAST Sphyg does not involve machine learning or AI models, and therefore does not have a "training set" in the computational sense.

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

   This information is not applicable. See point 8.

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Personnel properly trained in the use of blood pressurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multipatient device. It is available in child through large adult sizes.

The device is comprised of one or two tubes attached to an inflatable latex bladder, which is covered with a stitched nylon or cotton cover. The device is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. Sizes will include child through large adult. Each cuff will be packaged in a polyethylene bag.

The GSIBP Blood Pressure Cuff was evaluated against the AAMI SP9: 1994 standard to confirm its functional and physical performance characteristics were equivalent to the predicate device, ADCUFF™.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "The cuffs were equivalent in performance," implying a comparative study was performed, but the number of cuffs or trials is not detailed.
• Data Provenance: Not explicitly stated. Given that it's a conformity assessment to a standard for a medical device submitted to the FDA, it is highly likely a prospective study was conducted by the manufacturer, or a third-party laboratory. The country of origin of the data is not mentioned, but the submitting company is Globalshop Inc. (USA) and the predicate device is from American Diagnostic Corp. (USA), suggesting a US-centric context.

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

This is not applicable as the study involved objective physical performance testing against a standard, not expert interpretation of results that would require ground truth establishment by experts in the typical clinical sense. The "ground truth" here is the adherence to the engineering and performance specifications outlined in the AAMI SP9: 1994 standard.

4. Adjudication method for the test set:

Not applicable. The performance criteria are objective and measurable against the AAMI SP9: 1994 standard, not subjective interpretations requiring adjudication.

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 is a comparison of two physical medical devices (blood pressure cuffs) against a technical standard, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth used was the specifications and performance requirements outlined in the ANSI/AAMI SP9-1994 standard for non-invasive blood pressure measurement devices. The GSIBP cuff was compared to the ADCUFF™ predicate device to confirm equivalence against these criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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