Search Results

The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.

The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Bidop 7:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical study data for establishing sensitivity, specificity, or detailed performance metrics against a clinical ground truth for a novel AI/ML device. The "study" here refers to the testing performed to demonstrate compliance with standards and equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study. Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration of substantial equivalence to a predicate device (Smartdop 45, K050601).

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

The document does not describe a clinical "test set" in the context of an efficacy study with a specified sample size or data provenance (e.g., country of origin, retrospective/prospective). The testing described relates to engineering and regulatory compliance with standards, and comparison to the predicate device in terms of technology and indications for use. No patient data or clinical study data is detailed for an independent test set.

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

Not applicable. As no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication method is described.

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. The Bidop 7 is a cardiovascular blood flowmeter, not an AI-assisted diagnostic imaging device for which MRMC studies comparing human readers with and without AI assistance would typically be conducted. The document does not mention any AI components or MRMC studies.

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

Not applicable. The Bidop 7 is a medical device that produces diagnostic information (waveforms, numerical data, fetal heart rate) for interpretation by a human clinician. It is not an algorithm performing a standalone diagnostic task without human involvement. The document describes laboratory and engineering tests for compliance with standards and equivalence.

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

The concept of "ground truth" as typically applied in AI/ML performance evaluation (e.g., against pathology or clinical outcomes) is not discussed in this 510(k) summary. The comparison is primarily against specifications in standards and the performance characteristics of an existing predicate device. The underlying principle of operation (Doppler effect, photoplethysmography) itself is the "truth" that the device is designed to measure.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed with training data.

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

Not applicable. This device is not an AI/ML product developed with training data.

Summary of the Study (as described in the document):

The "study" presented in this 510(k) summary primarily consists of engineering verification and validation testing to ensure the Bidop 7 complies with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971) and FDA guidance for ultrasound systems and cybersecurity. The core of the submission demonstrates substantial equivalence to the predicate device, the Smartdop 45 (K050601), rather than a de novo clinical efficacy study. The document asserts that the general method of device construction and technology are identical, leading to the conclusion that the Bidop 7 is equivalent in safety and efficacy. No clinical trial data or performance metrics on a patient cohort are provided here; the focus is on technical compliance and equivalence.

Ask a specific question about this device

The Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link6 software that includes capabilities to print waveforms and export to into the facility's electronic health records.

It is not intended to be used in fetal applications or used inside the sterile field. It is intended to be used by licensed healthcare practitioners on adults and pediatrics only.

The Smartdop XT6 with Smart-XT-Link6 is designed to provide both qualitative information. The qualitative information mainly includes visual display of waveform's shapes, including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link6 software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

The Koven Technology, Inc. Smartdop XT6 (K153762) is a non-invasive device for evaluating peripheral vascular pathology. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the device's diagnostic capabilities (e.g., accuracy, sensitivity, specificity for ABI/TBI measurements). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and adherence to various medical device standards.

The primary "performance" reported is the demonstration of compliance with relevant standards and functional specifications that ensure the device operates as intended and safely.

• IEC 60601-1 (Medical electrical equipment)
• IEC 60601-1-2 (EMC)
• IEC 60601-2-37 (Ultrasonic medical diagnostic and monitoring equipment)
• ANSI/AAMI/IEC 80601-2-30 (Automated noninvasive sphygmomanometers)
• ANSI/AAMI/ISO 81060-1 (Non-invasive sphygmomanometers) |
  | Software Safety | Compliance with IEC 62304 (Medical device software) |
  | Risk Management | Compliance with ISO 14971 (Application of risk management to medical devices) |
  | Bio-Compatibility | Passed bio-compatibility testing by certified laboratories. |
  | Electrical Safety | Passed electrical safety testing by certified laboratories. |
  | Mechanical Safety | Passed mechanical safety testing by certified laboratories. |
  | Acoustic Output | Passed acoustic output testing by certified laboratories.
  (Specific for 8MHz probe: 390 mW/cm² or less) |
  | Labeling | Labeling includes instructions for safe and effective use, warnings, cautions, and guidance for use. |

Study Details for Acceptance

The document describes a series of tests and assessments performed, primarily focused on regulatory compliance and functional testing rather than a traditional clinical study with a test set of patient data and expert ground truth.

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

• Test Set Size: Not explicitly stated as a number of patient cases or samples in the context of diagnostic performance. The "testing" sections refer to compliance testing (e.g., electrical, mechanical, EMC) and internal verification/validation, not a clinical test set for diagnostic accuracy.
• Data Provenance: Not applicable for a traditional clinical test set. The compliance testing was likely conducted in a laboratory setting, and internal validation would use test data generated or simulated by the manufacturer.

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

• Not applicable. There is no mention of a test set requiring expert ground truth for diagnostic accuracy evaluation in this submission. The "ground truth" for the compliance and functional tests would be the established performance limits and specifications defined by the relevant standards and the device's design.

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

• Not applicable. There was no clinical test set requiring expert adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasonic transducer/Doppler system for physical measurements, not an AI-assisted diagnostic imaging interpretation tool.

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

• The device performs measurements (systolic pressures, blood flow, temperature) which can be considered "standalone" in the sense that the device itself generates these quantitative outputs. However, there's no "algorithm only" performance reported in the context of, for example, classifying disease or interpreting complex images without human input, as might be found in an AI/CADx device. The device provides "information" (qualitative waveforms, quantitative measurements) that is then used by a "licensed healthcare practitioner."

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

• For the technical and safety testing, the "ground truth" would be the established requirements and specifications of the referenced standards (e.g., IEC, ISO, ANSI/AAMI). For internal performance validation, the ground truth would be the defined functional specifications from the Device Master Record. There is no indication of clinical ground truth (e.g., pathology, outcomes) being used for performance evaluation in this submission.

7. The sample size for the training set:

• Not applicable. This document describes a traditional medical device (ultrasonic transducer) and does not refer to machine learning or AI components that would require a "training set."

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

• Not applicable, as there is no training set mentioned or implied for this device.

Ask a specific question about this device

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

Ask a specific question about this device

The Smartdop XT is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe- brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs and/or Doppler probe. The optional foot temperature provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link software that includes capabilities to print waveforms and export to into the facility's electronic health records.

It is not intended to be used in fetal applications or used inside the sterile field.

The Smartdop XT with Smart-XT-Link is designed to provide both qualitative and quantitative information. The qualitative information mainly includes visual display of waveform's shapes. including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

Here's an analysis of the provided text regarding the Smartdop XT device, focusing on its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K131623) is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance metrics against specific acceptance criteria for a novel device. The document mostly outlines a series of standards and guidance the device was designed to meet and states that testing was completed with acceptance to these standards. It doesn't explicitly list quantitative acceptance criteria with corresponding performance results in a table format.

However, based on the document's content, we can infer some implied acceptance criteria and the general statement of compliance:

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

The provided document does not specify a sample size for any clinical test set. The testing described is primarily focused on compliance with engineering and safety standards rather than clinical validation with a patient cohort. The document mentions "performance testing by certified laboratories" and "unit testing, verification, performance testing, and validation" internally, but these refer to bench testing and engineering verification, not clinical studies on patient data.

Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Since the testing described is not a clinical study involving diagnosis or interpretation of medical images/data by experts, the concept of "ground truth" as established by medical experts for a test set doesn't apply in the context presented.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a clinical test set requiring expert interpretation or diagnosis, there's no adjudication method described.

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 mentioned or described in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to standards, not on comparing human reader performance with and without AI assistance.

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

Given the nature of the device (an ultrasonic transducer for non-invasive peripheral vascular evaluation providing qualitative and quantitative information for examiner aid), it is likely designed for human-in-the-loop operation. The document describes it as aiding "the examiners in obtaining systolic segmental blood pressures."

No specific standalone algorithm performance study is described. The device is a diagnostic tool that provides data and waveforms, not an automated diagnostic algorithm meant to operate independently.

7. The Type of Ground Truth Used

Based on the described testing, the "ground truth" would be related to:

• Engineering and Safety Standards: Compliance with the numerous IEC, ISO, and ANSI/AAMI standards listed (e.g., electrical safety, acoustic output limits, EMI/EMC limits).
• Functional Specifications: The device's internal "functional specifications listed in the Device Master Record." This implies that the 'ground truth' for verification is defined by the manufacturer's own design requirements and expected performance parameters during bench testing.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical context within this document.

8. The Sample Size for the Training Set

The document does not mention or describe any training set for an algorithm. The Smartdop XT is an ultrasonic transducer and software system for data acquisition and display, not an AI/ML-based diagnostic algorithm that requires a training set.

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

Since there is no mention of a training set, this information is not applicable/not provided.

Ask a specific question about this device

The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.

The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.

The provided text describes a medical device, the "Valvulotome by Koven," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria, device performance metrics, or details of a study that would typically quantify its performance against such criteria.

The 510(k) summary primarily focuses on:

• Device Description: What the device is, its parts, and materials.
• Intended Use: For excising or disrupting venous valves during in-situ vascular procedures.
• Substantial Equivalence: Comparison to a predicate device (Lemaitre Valvulotome II, K946352).
• Testing: It states that testing was done, including "laboratory bond strength testing of all joined elements" and "bench testing for the determination of adequacy and safety of the device for the disruption of valves in blood vessels of the leg." It concludes that the device "successfully completed all testing with positive end points achieved."

Missing Information:

The document explicitly lacks the following information required to answer your prompt adequately:

• Specific Acceptance Criteria: No quantitative thresholds or qualitative standards are defined for "successful completion."
• Reported Device Performance: No specific data (e.g., success rates, force measurements, blade sharpness metrics, time to complete a procedure, etc.) from the testing is provided.
• Study Design Details:
  • No sample size for test sets (e.g., number of valves tested, number of devices tested).
  • No data provenance (country, retrospective/prospective).
  • No mention of experts, ground truth establishment, or adjudication for any performance testing.
  • No MRMC study details or AI components.
  • No standalone algorithm performance (as it's a mechanical device).
  • No details on training set size or ground truth for a training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and details.

The document's statement: "The Valvulotome by Koven successfully completed all testing with positive end points achieved" is a summary of the outcome, but it does not provide the underlying data or the specific criteria for "successful completion" that would be needed to fill the table. It indicates that some form of "adequacy and safety" was determined through bench testing related to disrupting valves, but the metrics are not specified.

Ask a specific question about this device

The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Peripheral Vascular.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.

The Smartdop 45 is a hand held bi-directional Doppler is designed to obtain blood flow velocity. Ultrasound is transmitted from probe to patient and is reflected by the moving object (blood flow). The reflected ultrasound is received by the probe and is converted into electrical signals. The incoming Doppler Shifted signals are applied to the Velocity Circuity Circuits to remove unnecessary signals and to provide a bi-directional readout. This phase-shifting technique is a standard method employed in direction seeking Doppler, known for several decades. It continues in wide use.

The waveform data are applied to the CPU for all the digital processing on LCD Display. The waveform data are applied to the off for the routing to the routing to the speaker to operate the analogue signals before digital processing.

The LCD display can display combined bi-directionally separated waveforms. The printer can print out patient information and waveform.

Integrated speaker provide Doppler sounds. A headset can be used, when is used it will mute the speaker.

The following probes may be utilized with the Smartdop 45 Doppler:

1. 2 MHz for fetal heart rate
2. 4 MHz detections of arterial and venous blood flow velocity
3. 5 MHz detections of arterial and venous blood flow velocity
4. 8 MHz detections of arterial and venous blood flow velocity
5. 10 MHz detections of arterial and venous blood flow velocity

The Smartdop 45 is intended for evaluation of the following:

• Fetal Heart rate
• ABI studies
• PEAK & MEAN blood velocity determinations
• Peripheral vascular procedures
• Blood pressure segmental studies
• Venous compressions
• Penile & digit systolic pressures
• Flow velocities in recovery room

The provided text is a 510(k) summary for the Koven Technology, Inc. Smartdop 45 Bi-Directional Doppler. It largely focuses on establishing substantial equivalence with a predicate device and safety information. There is no detailed study described that establishes explicit acceptance criteria with reported device performance in the way typically found in performance studies for AI/ML devices.

Here's an analysis of the provided information based on your request:

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

The provided text does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or similar performance measures for specific clinical tasks. Instead, it refers to "extensive safety, performance, and validation tests" and states the device "meets all of its functional requirements."

The closest the document comes to performance claims or criteria are the intended uses and the comparison to the predicate device. For example:

• "The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate."
• "The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator."
• "The Smartdop 45 has the same device characteristics as the predicate device, except... a 2 MHz fetal heart rate 2 MHz probe capability."
• "The conclusion drawn from these tests is that the Smartdop 45 device is equivalent in safety and efficacy to its predicated device."

Since no specific performance metrics are given, a table of acceptance criteria and reported device performance cannot be created from the provided text.

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

The document does not specify a sample size for a test set, nor does it provide information about data provenance. It mentions "extensive safety, performance, and validation tests" but offers no details on patients, samples, or data used.

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)

The document does not mention the use of experts to establish a ground truth for a test set. The testing appears to be functional and safety-focused, rather than a clinical performance study involving expert interpretation of results.

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

Since no test set is described as being evaluated by experts, there is no mention of an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study. This device is a standalone diagnostic tool (Doppler), not an AI-assisted diagnostic aid for human readers.

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

The "Test Data" section states that "The Smartdop 45 device has been subjected to extensive safety, performance, and validation tests prior to release... Final testing for the system includes various performance and validations prior to release. It includes tests designed to ensure that the device meets all of its functional requirements and operational performance capabilities."

This implies "standalone" testing was performed to verify the device's functional and operational performance, independent of human interpretation. However, the details of these tests are not provided. The device itself is intrinsically "standalone" in its function as a Doppler, providing data (waveforms, numerical data, heart rate) for a clinician to interpret.

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

The document does not specify a type of ground truth. Given the nature of a Doppler device, ground truth for measuring blood flow or fetal heart rate would typically involve comparison to established medical standards or other validated measurement devices. However, this is not explicitly stated.

8. The sample size for the training set

The document does not mention a training set, as it is not describing an AI/ML device.

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

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

Ask a specific question about this device

Detection and displays blood velocity motion, peak velocity, mean velocity and heart rate.
Evaluation of blood flow in patients with peripheral vascular disease, heart sounds and rates.

The Echo Sounder ES-101EX 8M is a single-handed vascular Doppler system that utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within arteries and display heart rate.
The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again.
The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

The provided text describes a 510(k) submission for the Echo Sounder ES-101EX 8M Vascular Doppler. However, it does not contain the detailed acceptance criteria or the specific study details (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that you have requested.

The document states: "The Echo Sounder ES-101EX 8M Doppler device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

This is a general statement that tests were conducted, but it doesn't provide the specifics of those tests, their acceptance criteria, or the reported performance outcomes. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar characteristics and general safety/performance testing, rather than presenting a detailed comparative effectiveness study with specific quantitative performance metrics against pre-defined acceptance criteria.

Therefore, many of your requested points cannot be answered from the provided text.

Here is a summary of what can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance (Not Provided in Detail)

The document generally states that "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" were conducted. However, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or reported device performance metrics against predefined criteria are listed.

Study Information

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

   • Not provided. The submission mentions "performance tests" and "functional requirements and performance specifications" but does not detail them or the results.

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

   • Not provided. No information on the sample size or type of data used for testing is given.

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):

   • Not provided. There is no mention of expert involvement in establishing ground truth for any test set.

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

   • Not provided. No information on adjudication methods is present.

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 / Not provided. The device described (Echo Sounder ES-101EX 8M Vascular Doppler) is a diagnostic tool that detects blood flow and heart rate. It is not an AI-assisted interpretation device that would involve human readers improving with AI assistance. The submission does not mention any MRMC study.

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

   • Not explicitly described as a "standalone algorithm performance study" in the modern sense. The document states: "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." This implied standalone device performance was evaluated, but no specific metrics or study design are given.

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

   • Not provided. The document does not specify how ground truth was established for any internal testing.

8. The sample size for the training set:

   • Not applicable / Not provided. This device is a traditional Doppler system, not an AI or machine learning algorithm that requires a training set in the typical sense.

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

   • Not applicable / Not provided. As it's not an AI/ML device, there's no training set or associated ground truth establishment.

In essence, the provided 510(k) summary is a high-level overview focused on establishing substantial equivalence through a comparison of basic characteristics and general safety/performance statements, rather than detailed clinical study data with specific acceptance criteria and performance metrics often seen with new or AI-driven technologies.

Ask a specific question about this device

Detection of fetal life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.

The Echo Sounder ES-101EX Single-handed Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Echo Sounder ES-101EX:

Summary of Device Acceptance Criteria and Performance:

Based on the provided 510(k) submission summary, the Echo Sounder ES-101EX Fetal Doppler is cleared through a substantial equivalence pathway. This means its acceptance criteria are primarily met by demonstrating that it is as safe and effective as a legally marketed predicate device, rather than through independent studies proving specific performance metrics against pre-defined thresholds.

The crucial statement is: "The conclusion drawn from these tests is that the Echo Sounder ES-101EX Singlehanded Fetal Doppler device is equivalent in safety and efficacy to its predicated device."

Therefore, the "acceptance criteria" are implicitly tied to the safety and efficacy profile of the predicate device (K023143, Echo Sounder, Model ES-102EX Fetal Doppler). The submission doesn't define specific numerical performance targets for sensitivity, specificity, accuracy, or other quantitative metrics that are often seen in AI/CADe device submissions.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of an AI/algorithm-driven device. The testing described is for the device itself (hardware and its inherent functionality), not for an algorithm that processes external data.

The text states: "The Echo Sounder ES-101X Single-handed Fetal Doppler device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

No details are provided regarding:

• The number of cases or subjects used in these "performance tests."
• The country of origin of any data (if human subjects were involved in testing).
• Whether the data would be considered retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not provided. The device is a traditional fetal Doppler, not an AI or imaging device where expert interpretation or "ground truth" derived from expert consensus would typically be established for performance evaluation. The "ground truth" for a fetal Doppler is the presence or absence of a fetal heartbeat, which is directly detected by the device's physical principle.

4. Adjudication Method:

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of complex data (e.g., medical images) where an algorithm's output is compared to a consensus reading. This device directly detects a physical signal.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed, nor is it applicable for this device. This type of study involves assessing how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Echo Sounder ES-101EX is a standalone diagnostic tool, not an AI-assistant for human interpretation.

6. Standalone Performance (Algorithm Only):

The device itself operates in a standalone manner to detect fetal heart sounds and display heart rate. However, the term "standalone performance" in the context of AI/CADe usually refers to the algorithm's performance independent of human input. Since this device is a physical diagnostic instrument and not an AI algorithm performing image analysis or similar tasks, the concept of a separate "algorithm only" performance is not directly applicable in the AI/CADe sense. The "performance tests" mentioned in the submission assess the device's ability to accurately detect and display the fetal heart rate, which is its primary function.

7. Type of Ground Truth Used:

The type of ground truth for a fetal Doppler is the actual presence or absence of fetal heart activity and its corresponding rate. This is a physiological signal, not a pathology finding from a biopsy or an outcome derived from long-term follow-up. The device directly measures this physical phenomenon.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The Echo Sounder ES-101EX is a hardware device based on the established principles of Doppler ultrasound. It does not use machine learning or AI, and therefore, there is no "training set" in the computational sense.

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

This information is not applicable/not provided for the same reasons mentioned above. There is no training set for this type of device.

Ask a specific question about this device

Detection of fetal heart rate, detection of multiple pregnancies. Verify fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.

The Echo Sounder ES-102EX Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

The provided 510(k) submission for the Echo Sounder ES-102EX Fetal Doppler does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-based diagnostic devices.

The Koven Technology Echo Sounder ES-102EX Fetal Doppler is a non-AI/ML medical device. It operates on the well-understood principle of Doppler shift to detect fetal heart activity. Its submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety testing (not performance-based on clinical outcomes), and compliance with industry standards, rather than clinical performance metrics that would require acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This type of detail is not presented for this device.
2. Sample size used for the test set and the data provenance: No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such 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, and its effect size: Not applicable as this is not an AI-assisted diagnostic device.
6. If a standalone performance study was done: Not applicable in the context of AI/ML algorithm-only performance. The performance deemed sufficient is its equivalence to predicate devices based on its technical operation.
7. The type of ground truth used: Not applicable for this type of device. Its "ground truth" would be the actual physical Doppler shift it detects, not a diagnosis or clinical outcome requiring expert consensus.
8. The sample size for the training set: Not applicable as this device does not use machine learning.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's content regarding device performance and acceptance:

The document states that the Echo Sounder ES-102EX Fetal Doppler has been "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, these are general statements and do not specify particular acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) or detail the studies performed to meet them.

The primary conclusion for clearance is based on substantial equivalence to predicate devices (K942441, K991441, K010889) in terms of safety and efficacy, implying that its performance is considered acceptable because it functions similarly to devices already on the market. The FDA letter confirms this, stating the device is "substantially equivalent...to legally marketed predicate devices."

The only specific testing mentioned is the requirement for a "postclearance special report" containing "acoustic output measurements based on production line devices," to ensure compliance with approved acoustic output levels. This relates to device safety, not clinical diagnostic performance in the way an AI/ML device would be evaluated.

Ask a specific question about this device

Ask a specific question about this device