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The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh (excludes pediatic subjects).

BlueTooth, wireless connectivity will be offered as an option.

The Oscar 2 monitor is worn by the patient on a waist belt and is connected to an ABPM blood pressure cuff around the non-dominant upper arm. The cuff is inflated automatically at intervals which can be programmed during setup. Blood pressure is measured by the oscillometric method which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured.

The Oscar 2 is a small hand-held or portable device, approximately 120 x 72 x 32 mm in size and weighs approximately 284 g including batteries. For convenience during a 24 hour study, the device can be worn with an optional pouch on a belt shoulder strap. The ABPM cuff is connected to the device, and the control buttons provide stop/start, day/night switch, event marking and dosage response capabilities. The LCD graphic screen allows for function monitoring and appropriate icon display. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by two (2) "AA" batteries located at the rear of the device. A USB port connection is used to download the patient information into the AccuWin Pro™ v4 software located on a separate PC. The AccuWin components include a flash drive and a USB cable.

Here's an analysis of the acceptance criteria and study information for the SunTech Medical Oscar 2, Model 250, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a comprehensive clinical trial report with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific performance numbers, sample sizes for test/training sets, expert qualifications, and adjudication methods for the new device's own performance studies is not directly present in this document. The document primarily states that the device was tested to applicable standards and demonstrated substantial equivalence to predicates.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance for the Oscar 2, Model 250 itself. Instead, it states that the device was tested to harmonized standards, implying that it met the requirements of those standards relevant to non-invasive blood pressure measurement. The key standard referenced for clinical investigation is ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type.

Likely Implied Acceptance Criteria (from ISO 81060-2:2013, general for NIBP devices):

While not explicitly stated in the document with actual results, conformance to ISO 81060-2:2013 typically requires the following for blood pressure measurement accuracy:

For Central Blood Pressure (CBP) Algorithm: The document states the device derives CBP and that the SphygmoCor® XCEL (a predicate device) also provides derived ascending aortic BP and central arterial indices. The acceptance criteria for the accuracy of a derived central blood pressure waveform and parameters are not detailed in this 510(k) summary. Given its reliance on the SphygmoCor® XCEL algorithm, it's likely they would have aimed to demonstrate comparable performance to that predicate, which itself would have had its own validation studies.

Study Details for the SunTech Medical Oscar 2, Model 250:

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

   • The document states that the device was tested to ISO 81060-2:2013. This standard generally requires a minimum of 85 participants for clinical investigation of automated non-invasive sphygmomanometers. However, the exact sample size used for this specific device's test set (Oscar 2, Model 250) is not specified in the provided text.
   • Data Provenance: Not specified. Typically, such studies are prospective, but this document does not state it. The country of origin of the data is also not mentioned.

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

   • Not specified. For NIBP validation under ISO 81060-2, manual reference blood pressure measurements are typically taken by a minimum of two trained observers (experts) following a specific protocol (e.g., auscultatory method). Their qualifications would typically involve being trained and validated against a mercury sphygmomanometer, but the exact information for this study is not provided.

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

   • Not specified. For NIBP validation, the "2+1" method (two observers, with a third if their readings differ significantly) or similar expert consensus is standard for establishing reference blood pressure. However, the document does not detail the method used.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is an automated non-invasive blood pressure monitor and does not involve human "readers" interacting with an AI to interpret images or data in a diagnostic context that would necessitate an MRMC study.

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

   • Yes, a standalone performance study was conducted implicitly. The statement that the device was "tested to the applicable requirements of the following standards and requirements" including ISO 81060-2:2013 indicates that the device's algorithmic performance in measuring blood pressure was assessed independently against a reference standard. The nature of an automated sphygmomanometer being a measurement device means its primary function is standalone measurement. While human operators apply the cuff and initiate measurements, the core blood pressure calculation is algorithmic (standalone).
   • The Central Blood Pressure (CBP) algorithm's performance is also implicitly standalone, deriving the waveform and parameters from the brachial cuff measurements.

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

   • For brachial blood pressure measurement validation (per ISO 81060-2), the ground truth is typically established by simultaneous, direct arterial measurement using an invasive catheter (less common in routine validation) or, more commonly, manual auscultatory measurements obtained by trained observers using a mercury sphygmomanometer (or equivalent validated reference cuff device) on the contralateral arm or sequentially. The document implies the latter through its reference to ISO 81060-2.
   • For the derived central blood pressure, the ground truth would typically be invasive central blood pressure measurements, though the document relies on substantial equivalence to a predicate that also derives this non-invasively. The validation of the derivation itself would typically involve comparison to invasive central measurements.

7. The sample size for the training set:

   • Not specified. This document does not provide details about a training set for the NIBP or CBP algorithms. For a device like this, the algorithms would typically be developed and potentially refined using various datasets, but a distinct "training set" for regulatory submission is not usually detailed in this type of 510(k) summary unless the AI component is novel and centrally a "machine learning" algorithm in the modern sense. Given the age of the submission (2016) and the nature of an oscillometric algorithm, it's more likely based on established physiological models and signal processing rather than deep learning requiring large, explicitly defined training sets.

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

   • Not applicable/Not specified, as no specific "training set" details are provided. If implicitly part of algorithm development, the ground truth would be established similarly to the test set (e.g., expert-referenced blood pressure values).

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The SunTech Medical Tango M2 NIBP monitor with optional Pulse Oximeter is indicated for use in measuring and displaying blood pressure, heart rate, functional oxygen saturation of arterial hemoglobin (SpO2) of adult patients in hospitals, medical facilities, and subacute environments.

The Tango M2, a microprocessor based blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango M2 has the ability to make blood pressure and saturation measurements at predetermined intervals (normally from a schedule determined by the physician), or on demand. Additionally, the TangoM2 has the ability to make an Oscillometric blood pressure determination at the command of the operator while the patient is stationary.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SunTech Medical Tango M2 Blood Pressure Monitor:

Unfortunately, the provided text does not contain the detailed acceptance criteria or the specific study results that comprehensively prove the device meets these criteria in the format requested. The document is primarily a 510(k) summary for a Special 510(k) submission, focusing on establishing substantial equivalence for a modified device rather than presenting a de novo performance study.

Here's what can be extracted and what is missing based on your request:

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

This information is not explicitly provided in the given text. The document states that the Tango M2 has been tested to applicable standards and requirements, and these tests "have indicated passing results," but it does not specify what those acceptance criteria were for blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method) or the actual results achieved.

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

This information is not provided. The 510(k) summary does not detail a specific clinical test set for performance validation, as it is a Special 510(k) based on modifications to an existing device.

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. As no detailed performance study is presented, there's no mention of experts establishing a ground truth.

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

This information is not provided.

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 this device. The Tango M2 is a blood pressure monitor, not an AI-assisted diagnostic imaging device used by human readers.

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

The device is a standalone blood pressure monitor ("algorithm only" in the sense that it automatically determines blood pressure). However, the document does not present a standalone performance study with specific results. It references "Korotkoff sounds to determine blood pressure," which is the underlying method, but no detailed performance numbers are given.

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

This information is not explicitly stated in the provided document. For blood pressure monitors, the "ground truth" during validation typically involves a reference standard method like invasive arterial line measurements or auscultation by trained observers (often two observers blinded to each other's readings and the device reading), following protocols like ISO 81060-2. The document infers a reliance on established methods by stating "uses Korotkoff sounds to determine blood pressure," which is a standard method for reference.

8. The sample size for the training set:

This information is not applicable and not provided. Blood pressure monitors using Korotkoff sounds are typically based on established physiological principles and signal processing, not on machine learning models requiring extensive "training sets" in the modern AI sense.

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

This information is not applicable and not provided for the reasons mentioned above.

Summary of available information:

The document states that the Tango M2 is a non-invasive blood pressure monitor that uses Korotkoff sounds and an optical finger sensor for oxygen saturation. It measures and displays systolic and diastolic blood pressure, and optionally SpO2, for adult patients during cardiac or exercise stress testing under physician supervision.

The basis for regulatory acceptance is substantial equivalence to predicate devices (Tango+ K053209 and Tango K970629). The crucial statement regarding performance is: "The Tango M2 has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The listed standards are:

• IEC 60601-1:2005: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2:2007: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

While these standards cover safety and EMC, they don't explicitly define blood pressure measurement accuracy acceptance criteria (which would typically be covered by standards like ISO 81060-2 or AAMI SP10). The document implicitly relies on the fact that the specifications and measurement ranges are the same as the predicate devices, which were previously cleared based on their performance.

In conclusion, this 510(k) summary provides evidence of safety and EMC compliance and asserts substantial equivalence, but it does not present a detailed performance study with specific acceptance criteria and outcome data as you've requested for a new device's performance validation.

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The Disposable Blood Pressure cuff is intended to be used with a non-invasive blood pressure measurement system to determine blood pressure parameters on neonate, pediatric and adult patients.

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 is connected to a non- invasive blood pressure measurement system. The device is available in the following configurations:
· 15 sizes (five neonate, ten pediatric/adult)
· Single and dual cuff tubing with connectors available for use with a wide variety of manual and automated sphygmomanometers

This submission describes a disposable blood pressure cuff. The relevant information related to acceptance criteria and performance studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against two recognized standards and an internal marketing specification. The submission states, "These tests have indicated passing results." However, specific numerical acceptance criteria and the detailed performance results for each criterion are not provided in this document.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "The Disposable Blood Pressure Cuff has been tested to... standards and requirements."

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

This information is not applicable to the type of device and testing described. The device is a physical medical device (blood pressure cuff), and its performance is assessed against technical standards for accuracy and safety, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a physical device like a blood pressure cuff, performance is measured objectively against technical standards.

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

An MRMC comparative effectiveness study is not applicable as this device is a disposable blood pressure cuff, not an AI-powered diagnostic tool that assists human readers.

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

This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by the specified industry standards (AAMI SP10: 2002 and IEC 60601-2-30:1999) and an internal marketing specification. These standards define the acceptable range of accuracy for blood pressure measurements and other physical and safety features of the cuff. The device's performance is measured against these objective criteria.

8. The sample size for the training set

This information is not applicable. The development and testing of a physical blood pressure cuff do not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications, prototyping, and validation testing.

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

This information is not applicable, as there is no "training set" in the context of this device. The "ground truth" for general design and safety parameters would be established by relevant engineering principles, material science, and regulatory requirements that predate the specific device being developed.

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The SunTech Medical 247 NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

The 247 BP, Temperature and Pulse Oximeter device, a microprocessor based noninvasive blood pressure, predictive temperature and oxygen saturation measurement system, uses oscillometric signals to determine blood pressure, oral, rectal or auxiliary probes to determine temperature and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff. Deflation of the cuff is controlled by two valves. Implementation of Pulse Oximetry and temperature is achieved through the incorporation of OEM devices from companies with currently marketed products and accessories.

The provided text is a 510(k) summary for the SunTech Medical 247 NIBP, Temperature, and Pulse Oximeter device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with specific acceptance criteria and detailed performance metrics as would be found in a multi-reader, multi-case (MRMC) study for an AI-powered diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC study effect size, standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's validation against relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device has been tested to applicable requirements of several standards, and these tests "have indicated passing results." However, it does not provide specific numerical acceptance criteria or performance metrics (e.g., accuracy, precision, sensitivity, specificity) within the text itself for blood pressure, temperature, or SpO2 measurements. The acceptance criteria for these types of devices are typically defined within the cited standards.

Note: "Passing results" indicates that the device met the criteria specified in each standard, but the specific numerical thresholds and the exact performance achieved are not detailed in this summary.

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
  This type of information is typically found in the detailed test reports that are referenced but not included in this summary.

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

• Not applicable. This device is a measurement device, and its "ground truth" is typically established by comparison to other validated measurement devices or by using physical standards, not by expert consensus in the diagnostic sense.

4. Adjudication method for the test set:

• Not applicable. (See answer to #3.)

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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a vital signs monitor and does not involve human readers interpreting images or data in the context of an AI-assisted diagnostic workflow.

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

• The device itself is a "standalone" system in the sense that its algorithms perform the measurements (NIBP, SpO2, temperature) without human intervention in the calculation process. However, a specific "standalone" study comparing algorithm-only performance to a human-in-the-loop scenario is not applicable here as it's a measurement device, not an AI diagnostic tool. Its performance is validated against established measurement standards.

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

• The ground truth for this type of measurement device is typically established against reference standards or calibrated instruments as defined by the cited standards (e.g., AAMI SP10 for NIBP, ISO 9919 for Pulse Oximetry, E1112 for thermometers).

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" for diagnostic pattern recognition. Its underlying algorithms are based on established physiological principles and signal processing.

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

• Not applicable. (See answer to #8.)

Summary of what can be inferred from the document:

The SunTech Medical 247 device demonstrates its meeting of acceptance criteria by undergoing and passing tests against recognized international and national standards for medical devices and vital signs measurement. These standards define the acceptable performance limits for non-invasive blood pressure, pulse oximetry, and electronic thermometers. The 510(k) summary states that the device has "indicated passing results" for these tests, implying compliance with the performance and safety requirements outlined in the standards. The study mentioned is a series of compliance tests against these standards, not a clinical trial with a detailed statistical analysis of patient data in the context of an AI application.

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The SunTech Medical Cycle BP monitor and Pulse Oximeter is indicated for use in measuring and displaying systolic and diastolic blood pressures, heart rate, and functional saturation of arterial hemoglobin (SpO2) of adult and pediatric patients in hospitals, medical facilities and subacute environments.

The Cycle BP Monitor and Pulse Oximeter, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system compatible with ergometer stress-test systems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. The Cycle has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The provided text describes the SunTech Medical Cycle BP Monitor and Pulse Oximeter, its intended use, and its equivalence to a predicate device. It references several standards and tests, but it does not provide explicit acceptance criteria or detailed study results for device performance against those criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance directly from the given text.

Here's what I can infer and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The document broadly states that "The Cycle BP Monitor has been tested to the applicable requirements of the following standards and requirements. These tests have indicated passing results." The specific standards listed are:

• AAMI SP10: 2002 (American Association for Medical Instrumentation, standard for sphygmomanometers)
• IEC 60601-1:1996 (Medical electrical equipment – Part 1: General requirements for safety)
• IEC 60601-2-30:1999 (Medical electrical equipment – Part 2-30: Particular requirements for the safety of automatic electronic sphygmomanometers)
• ISO 9919:1992 (Pulse oximetry equipment – Particular requirements for safety and essential performance)
• IEC 60601-1-2:2001 (Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests)
• IEC 60601-1-4:2000 (Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems)
• IEC 60601-2-49:2001 (Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment)
• Functional Specification, (SunTech document # 99-0049-XX-FS)

The document claims that the device "indicated passing results" for these tests, implying that the studies conducted in accordance with these standards demonstrated compliance with their respective criteria. However, no specific data or methodology details of these studies are provided in this extract.

Missing Information from the provided text:

Due to the nature of this submission (abbreviated 510(k) summary), the detailed information about the studies is not included. The following points cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not available in the document. For AAMI SP10, there are specific requirements for subject demographics (e.g., age, blood pressure range, gender distribution) and a minimum number of subjects (typically 85 for clinical validation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the document. For AAMI SP10, ground truth (reference blood pressure) is typically established by at least two trained observers taking simultaneous auscultatory measurements.
4. Adjudication method for the test set: Not available in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone blood pressure and pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself performs the measurements. The "tests have indicated passing results" for standalone performance according to the listed standards.
7. The type of ground truth used: For Blood Pressure, it's highly likely to be expert auscultation as per AAMI SP10. For SpO2, it would be co-oximetry (invasive blood gas analysis).
8. The sample size for the training set: Not applicable/Not available. This device (from 2006) would likely use a deterministic algorithm or a simpler calibration model rather than a machine learning model that requires a "training set" in the modern AI sense. Even if it involved some algorithm development, the specifics are not disclosed.
9. How the ground truth for the training set was established: Not applicable/Not available.

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The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.

The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.

1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.

The provided 510(k) submission document for the SunTech Medical Inc. Tango + System largely focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards, with less detail on the specific clinical study design and results for establishing acceptance criteria for device performance.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the SpO2 system was validated in a clinical test but does not provide specific numerical acceptance criteria for either blood pressure or oxygen saturation, nor does it present the quantitative results of these clinical tests. It only broadly states that the device "will have passed" several non-clinical tests and that the SpO2 system was "thoroughly tested" and "validated in a clinical test."

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The SpO2 system was validated in a clinical test." However, it does not provide any information regarding:

• The sample size used for this clinical test.
• The country of origin of the data.
• Whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document for either the blood pressure or SpO2 validation.

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

A MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's standalone performance and its equivalence to predicate devices.

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

Yes, the information provided strongly suggests that a standalone performance evaluation was conducted, particularly for the SpO2 system. The statement "The SpO2 system was validated in a clinical test" implies evaluating the device's inherent measurement capabilities. For blood pressure, the direct reference to ANSI/AAMI SP10 suggests a standalone performance evaluation against the requirements of that standard.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for either blood pressure or SpO2 measurements in the validation studies.

• For blood pressure, given the common practice for non-invasive blood pressure devices, the ground truth would typically be invasive arterial pressure measurements or auscultation by trained observers (double auscultation with a mercury sphygmomanometer) as per standards like ANSI/AAMI SP10.
• For SpO2, the ground truth for validation studies usually involves co-oximetry (arterial blood gas analysis) to directly measure fractional oxygen saturation in arterial blood, often under controlled desaturation conditions.

8. The Sample Size for the Training Set

The document does not provide any information on a training set or its sample size. This is typical for a 510(k) submission unless the device involves complex machine learning algorithms that require explicit training and validation sets. The Tango+ System appears to be based on established physiological measurement principles (Korotkoff sounds for BP, optical finger sensor for SpO2) rather than a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not applicable/not provided.

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The All Purpose Cuff is intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. They are not intended to be used on neonates. They are intended to be used with prescription (clinical grade) blood pressure monitors; they also could be used with Prescription Use X (Part 21 CFR 801 Subpart D) (AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

The All Purpose Cuff is an accessory for noninvasive blood pressure systems. It is comprised of a connector attached to tubing attached to an air tight bladder which is enclosed within an inelastic sleeve. The All Purpose Cuff comes in a range of sizes. Each is marked with the appropriate limb circumference for which the cuff is intended.

The provided text describes a 510(k) summary for the SunTech Medical All Purpose Cuff. However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document states that the device has been "tested to the applicable requirements" of various AAMI, EN, and IEC standards, and "These tests have indicated passing results." It also mentions a "Marketing Specification, (SunTech document # 97-0037-XX-FS), version 11," but the content of this specification is not provided.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

Here's a breakdown of what could be provided based on the very limited information, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states testing was done according to AAMI SP10, EN1060, and IEC60601-2-30. These standards would contain specific performance criteria (e.g., accuracy, pressure stability, leak rates) for blood pressure cuffs, but the document does not enumerate them or report the specific numerical performance of the device against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Missing Information: The document does not specify any sample sizes for testing or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "These tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Missing Information: There is no mention of experts, ground truth establishment, or any human-based evaluation in the provided text. The testing appears to be primarily related to engineering and performance standards for the physical cuff itself.

4. Adjudication Method for the Test Set

Missing Information: Not applicable, as no expert evaluation or ground truth establishment process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Missing Information: This device (All Purpose Cuff) is a physical blood pressure cuff, not an AI-powered diagnostic tool interpreting medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Missing Information: This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "standalone" performance would be its inherent physical performance characteristics as a cuff. The document states "These tests have indicated passing results" for various standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Missing Information: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus for image interpretation) is not explicitly discussed for this device. The "ground truth" for a blood pressure cuff's performance would be derived from physical measurements against calibrated references and adherence to engineering standards. The specific methods are not detailed beyond referencing AAMI, EN, and IEC standards.

8. The Sample Size for the Training Set

Missing Information: This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

Missing Information: Not applicable, as there is no "training set" for this physical device.

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