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The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.

The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.

This document describes the Huntleigh Healthcare Ltd DMX/SRX Handheld Doppler and Probes, and its substantial equivalence to predicate devices. It focuses on engineering and performance verification, rather than clinical studies with acceptance criteria in the context of device performance metrics like sensitivity or specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the DMX/SRX Handheld Doppler, especially in comparison to clinical outcomes. Instead, it details various engineering and regulatory compliance testing.

The document states that "The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use." This implies that the acceptance criteria are met if the new device demonstrates similar performance and safety characteristics as the legally marketed predicate devices through the conducted verification and validation tests.

Below is a table summarizing the types of testing performed, which serve as the basis for demonstrating equivalence and meeting "acceptance criteria" in a broad sense for a 510(k) submission:

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The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique.

The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits.

THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.

Identically to the predicate devices K090009, K081429 e K070815, the THD Revolution is a 8 MHz continuous wave (CW) Doppler detector with a loudspeaker and a light source.

Further, as the predicate device, the THD Revolution doppler is used with dedicated accessories (optical fiber and pneumatic foot pedal) and a dedicated kit containing a proctoscope, needle holder, knot tightener, sutures, doppler probe and Surgy proctoscope in order to allow the surgical operation through the Transanal Hemorroidal Dearterialization (THD) technique.

The provided document is a 510(k) Summary for the THD Revolution device. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. It also details performance testing, but it does not contain typical "acceptance criteria" and "reported device performance" in the format of a table as might be found in a study for a new AI/software device. This is due to the nature of the device (a nonfetal ultrasonic monitor with a light source used for surgical treatment) and the type of submission (a 510(k) for substantial equivalence to existing devices, not a de novo submission for a novel device).

Therefore, I will extract the closest relevant information from the document to construct the answer, particularly from "2.8 Performance data", highlighting the differences and similarities with predicate devices which serve as the basis for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not specify formal, quantitative acceptance criteria for the THD Revolution as a new, standalone device, nor does it present "reported device performance" against such criteria in a typical tabular format. Instead, it demonstrates substantial equivalence to predicate devices by showing that the THD Revolution's performance is either the same as or improved upon the predicate devices without raising new safety questions.

The "performance data" section focuses on:

• Compliance with recognized standards.
• Acoustic signal quality, specifically addressing the improved clarity due to DSP technology.
• Light source efficacy and photobiological safety.
• Clinical effectiveness in treating hemorrhoidal disease, extending to Grade IV.

Here's an attempt to synthesize the information into a table format, focusing on the comparisons made:

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 primarily relies on two clinical studies for surgical efficacy:

• Study 1: Giorndano P, et al. Colorectal Dis. 2014 May;16(5):373-6.

  • Sample Size: 31 patients.
  • Data Provenance: Not explicitly stated, but authors' names and journal suggest potential European origin. The abstract mentions "Colorectal Dis." which is a UK-based journal.
  • Retrospective/Prospective: Not explicitly stated, but typical for such intervention studies, it would likely be prospective observation or a clinical trial. The text says "were operated," which could imply retrospective data collection on outcomes, but the context of proving effectiveness for Grade IV hemorrhoids often means dedicated follow-up.

• Study 2: Morrett R.S. Crujano General. Vol 34 Num 2; 2012.

  • Sample Size: 250 patients (including 21 patients with Grade IV hemorrhoids).
  • Data Provenance: "Crujano General" is likely "Cirujano General," a Spanish-language journal for general surgeons, suggesting data from a Spanish-speaking country (e.g., Mexico, Spain, Latin America).
  • Retrospective/Prospective: Not explicitly stated. Similar to Study 1, "were operated" suggests observation of outcomes post-procedure.

For technical performance (acoustic output, signal quality, luminous efficacy), the "tests were conducted" using the THD Revolution and predicate devices. No sample size of devices or specific data provenance is mentioned beyond "a THD Revolution prototype representative of the standard THD SpA production."

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 section is not applicable in the context of this device and submission. The performance of the THD Revolution is evaluated based on its physical/electrical characteristics and clinical outcomes (e.g., recurrence, pain, satisfaction) as reported in surgical studies, rather than by human expert interpretation of output (like in imaging AI). The "ground truth" for surgical efficacy is the patient's clinical outcome after the procedure, as assessed by the operating physician and patient reporting.

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

This is not applicable. The clinical studies cited concern surgical outcomes, not diagnostic 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

This is not applicable. The THD Revolution is a surgical device, not an AI software intended to assist human readers in interpretation. There are no "readers" involved in this use case, and thus no MRMC study or AI assistance effect size.

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

This is not applicable. The THD Revolution is a hardware device (an ultrasonic monitor with a light source) used by a surgeon. It does not operate as a standalone algorithm in the sense of AI or software. Its operation is always "human-in-the-loop" as it requires a specialist physician to use it for diagnosis and surgery.

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

For the clinical effectiveness data:

• Outcomes data: The primary ground truth for clinical efficacy is the patient's clinical outcome (e.g., resolution of hemorrhoids, absence of intra-operative complications, recurrence rates, post-operative pain levels, patient satisfaction). This is determined by the treating physicians' assessments and patient self-reports.

For the technical performance data (acoustic output, luminous efficacy, safety):

• Objective measurements and international standards: Ground truth is established by objective measurements using calibrated equipment (e.g., illuminance meter) and compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62471).

8. The sample size for the training set

This is not applicable. The THD Revolution is a hardware device. It does not use Machine Learning or AI models that require a "training set" of data.

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

This is not applicable, as there is no training set for this device.

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The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

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

The 5MHz, 8MHz, or PPG probes are designed for peripheral vascular applications.

The nominal 5MHz probe previously submitted and approved under K090465.

The nominal 8MHz probe previously submitted and approved under K090465.

The PPG probe is intended for vascular applications to determine blood flow in digits.

The simpleABI is a diagnostic ultrasound system. The system consists of a main body and one probe. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

The provided document is a 510(k) premarket notification letter from the FDA to Newman Medical for the simpleABI device. It primarily focuses on the substantial equivalence determination for the device and its transducers to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance metrics, or any specific study results (including clinical or standalone performance studies) that would prove the device meets acceptance criteria. It also does not discuss sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or details on training sets.

The relevant sections of the document describe:

• Device Name: simpleABI
• Regulation Number/Name: 21 CFR 892.1540, Nonfetal ultrasonic monitor
• Regulatory Class: II
• Product Codes: JAF and ITX
• Indications for Use: "The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, cherce une values, and index results can be printed directly from the system."
• Included Transducers: 5 MHz, 8 MHz, PPG, all for Peripheral Vascular application (CWD mode for 5MHz and 8MHz, and new indication 'N' for PPG as mentioned on page 3)

Since the document does not provide the requested information regarding acceptance criteria and study data, I cannot complete the table or answer the specific questions about performance studies. The FDA 510(k) clearance process generally focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics in the way a PMA approval might.

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This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries. The product includes two interchangeable ultrasound transducer probes and user replaceable batteries. The user interface includes an on/off button, volume control, 12 button keypad for entering pressure data and printing, single 2-1/4" speaker, and LCD display for displaying data, battery and waveform information. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic and hypoallergenic aqueous gel used for ultrasound transmission.

The Summit Doppler Systems, Inc. LifeDop 300ABI is a handheld, battery-powered, audio Doppler device used to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission is a 510(k) for substantial equivalence and there is an explicit statement "Clinical Testing: None provided," there are no specific performance acceptance criteria or reported device performance metrics in the provided document. The basis for clearance is solely on the similarity to a predicate device.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there is no test set sample size or data provenance to report.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there are no experts or ground truth establishment details to report.

4. Adjudication Method for the Test Set:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no adjudication method was used.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a diagnostic ultrasound monitor, not an AI-assisted diagnostic tool.

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

A standalone performance study was not done. The device is a diagnostic ultrasound monitor, not an algorithm, and its use inherently involves a human operator to interpret the audio Doppler signal.

7. The Type of Ground Truth Used:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no ground truth was established by expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

No clinical testing was conducted or provided for this 510(k) submission. Therefore, there is no training set sample size to report.

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

No clinical testing was conducted or provided for this 510(k) submission. Therefore, no ground truth for a training set was established.

Summary of the Study:

The provided documentation (K093393) for the Summit Doppler Systems, Inc. LifeDop 300ABI explicitly states "Clinical Testing: None provided." The 510(k) clearance was based on demonstrating substantial equivalence to a previously cleared predicate device, the Summit Doppler Systems LifeDop Doppler Ultrasound System (K024197). The argument for substantial equivalence relies on comparisons of device features, materials, intended use, and performance, asserting that the new device utilizes the same Doppler ultrasound technology and has no change in intended use compared to the predicate. Therefore, no clinical studies were performed to establish performance metrics, acceptance criteria, or ground truth for this specific submission.

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The THD Slide One Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD proctoscope, sutures and a needle holder included in the THD Kits.

The THD Slide One is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD Slide One consists of the THD Evolution Doppler device and the THD Slide One Kt. The THD Evolution Doppler device is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Slide One Kit is a sterilized surgical kit comprised of a proctoscope, needle holder, knot tightener, sutures and Doppler probe. The kits used for the surgical treatment could be the THD Slide One kit or one of the kits already cleared by THD/G.F .; the THD kit that was included in the THD Submission (K070815) or the THD Slide (K081429)

The provided text describes a 510(k) summary for the THD Slide One, a nonfetal ultrasonic monitor. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance metrics.

The document primarily focuses on:

• Administrative details: Submitter, contact persons, summary preparation date, device names, classification, and predicate devices.
• Device description: Components of the THD Slide One system (THD Evolution Doppler device and THD Slide One Kit) and their function.
• Indications for Use: What the device is intended for (surgical treatment of second and third-degree hemorrhoids using Doppler-guided Transanal Hemorrhoidal Dearterialization technique).
• FDA Clearance Letter: Confirmation of substantial equivalence to a predicate device and permission to market.

Therefore, it is impossible to provide the requested information as the input text does not contain any data related to acceptance criteria, device performance studies, or ground truth establishment.

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The THD Slide Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD Slide proctoscope, sutures and a needle holder included in the THD Slide Kit.

The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD Slide consists of the THD Evolution Doppler device and the THD Slide Kit. The THD Evolution Doppler is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Kit is a sterilized surgical kit comprised of a proctoscope, a needle holder, a knot tightener and sutures.

The provided text describes a 510(k) summary for the THD Slide, a medical device. This summary primarily focuses on regulatory approval based on substantial equivalence to a predicate device and acoustic emission testing. It does not contain the detailed information typically found in a study demonstrating clinical performance or meeting specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections below cannot be fully populated from the provided document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance Study for THD Slide

The THD Slide's acceptance criteria primarily revolve around its substantial equivalence to a predicate device and meeting safety standards related to acoustic emissions, rather than specific clinical performance metrics. The study mentioned is limited to acoustic output measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Max Values:
MI: 0.032
Ispta3: 322 mW/cm²
Beam Area: 3.880 mm²
Wo: 18.500 mW

These reported values are stated to be below the recommended upper limits. |

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

• Sample Size for Test Set: Not applicable in the context of clinical performance data. For acoustic emissions, the 'test set' would refer to the measurements taken on the device itself. The document does not specify how many individual measurements were taken or if multiple devices were tested; it provides mean, standard deviation, and max values, implying multiple measurements.
• Data Provenance: The acoustic emission data would have been generated internally by the manufacturer (THD S.p.A.) as part of product testing to demonstrate compliance with standards. The country of origin for the device manufacturer is Italy.

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

• Not applicable as the 'ground truth' here relates to objective physical measurements (acoustic output) rather than expert interpretation of clinical data. Compliance with acoustic output limits is typically determined by specialized engineers and equipment.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images). For acoustic emissions, measurements are objective and compared against pre-defined regulatory limits.

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. This is not an AI/algorithm-based device in the sense of image interpretation or diagnostic assistance. It's an ultrasonic Doppler device used for guiding a surgical procedure. Therefore, an MRMC study or AI assistance evaluation is irrelevant to this submission.

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

• No. This device is not an algorithm that operates in a standalone manner. It is a physical medical device (Doppler probe and surgical kit) used by physicians to guide a surgical procedure.

7. The type of ground truth used

• For the acoustic emissions, the "ground truth" is adherence to established regulatory limits and standards for ultrasonic output, measured by calibrated equipment.
• For substantial equivalence, the "ground truth" is a regulatory determination made by the FDA based on comparison to an already cleared predicate device (K07081) regarding indications for use, technological characteristics, and safety/effectiveness. There is no clinical "ground truth" such as pathology or outcomes data presented in this specific 510(k) summary.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

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

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

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The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit.

The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD consists of the THD Evolution Doppler Device and the THD Kit. The THD Evolution Doppler is a 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler must be used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation.

The THD Kit is a sterilized surgical kit comprised of a proctoscope, sutures, a needle holder and a knot tightener.

This document details the 510(k) submission for the THD (Transanal Hemorrhoidal Dearterialization) device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The provided text is primarily a 510(k) summary, focusing on device description, indications for use, and a comparison to predicate devices for substantial equivalence.

The "Performance Data" section solely discusses acoustic output parameters of the THD Evolution Doppler and compares them to limits for diagnostic ultrasound systems, not clinical performance for treating hemorrhoids.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence to predicate devices based on safety and basic functional characteristics, rather than a detailed performance study with specific acceptance criteria related to its clinical efficacy.

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This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.

The Vista AVSTM is a diagnostic ultrasound device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi-directional Doppler for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Two additional modalities, Pulse Cuff Recording (PCR) and Photoplethysmography (PPG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, and the PPG will be used primarily to obtain toe pressures. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the device or uploaded using AVS ReportTM report generating software and an external user supplied PC via a USB port. The unit can run from an internal power source or from an external power supply, and mounts to a rolling stand.

The Summit Doppler Systems, Inc. Vista AVS is a diagnostic ultrasound device intended for the detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease. It measures systolic pressure values, provides bi-directional Doppler for blood flow, and controls pressure cuff inflation/deflation. It also incorporates Pulse Cuff Recording (PCR) and Photoplethysmography (PPG) and calculates Ankle Brachial Index (ABI) or Toe Brachial Index (TBI).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K063600) is a 510(k) premarket notification for substantial equivalence, not a detailed clinical study report with specific acceptance criteria and performance metrics for the device itself. The submission claims substantial equivalence to a predicate device (IMEXLAB 9100 Diagnostic Ultrasound Device, K973562).

Therefore, there are no explicit "acceptance criteria" or "reported device performance" metrics directly stated for the Vista AVS in this document in the typical sense of a clinical trial. Instead, the "acceptance criteria" can be inferred as demonstration of equivalence in:

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

The provided document does not describe a test set or clinical study specific to the Vista AVS for demonstrating performance against defined criteria. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to a legally marketed predicate device. There is no mention of patient data, sample sizes, or data provenance (country of origin, retrospective/prospective).

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

Since no specific test set or clinical study is described for the Vista AVS in this submission, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no described test set, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, not on directly 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

The Vista AVS is described as a diagnostic ultrasound device that aids clinicians. It is not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance without human-in-the-loop is not applicable here, and no such study is mentioned.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not applicable to this 510(k) submission. The submission is based on demonstrating substantial equivalence to a predicate device, meaning its "ground truth" for regulatory clearance is that it functions safely and effectively like the predicate device for its intended use.

8. The Sample Size for the Training Set

The Vista AVS is a physical medical device utilizing established Doppler ultrasound technology. It is not an AI system that requires a "training set" in the machine learning sense. Therefore, there is no information about a training set size.

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

Since the Vista AVS is not an AI system developed with a machine learning training set, this question is not applicable.

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Diagnostic ultrasound blood flow detection of the human body. The Stethoflux is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation. It facilitates: - the detection of blood-flow in the peripheral arteries - Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer

Acoustic stethoscope with ultrasonic transducer. It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode. Powered by one (6LR61) 9V lenium battery. Doppler frequency: 8 MHz. Operating time 25 h according to use. Mass 331 g.

The provided document is a 510(K) Premarket Notification Submission for the "Acoustic and Doppler Stethoscope Stethoflux®". It states that the device is substantially equivalent to a predicate device (K030466, HandyDop TM, Elcat GmbH) and does not provide detailed acceptance criteria or a dedicated study description with specific performance metrics beyond stating "Similar specifications for the common application with the 8 MHz probe."

The document explicitly states:

• "There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence."
• "Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission." (However, these clinical data are not present in the provided text.)

Therefore, based on the information provided, it is not possible to complete most of the requested sections as the submission relies on demonstrating substantial equivalence rather than meeting pre-defined acceptance criteria through detailed performance studies.

Here's what can be extracted and what cannot:

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

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

Not provided in the document. The text states that performance standards and clinical/non-clinical test data are "Not required for determination of substantial equivalence for this class of device."

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 in the document.

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

Not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a doppler stethoscope, not an AI device. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a medical device, not an algorithm.

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

Not provided in the document.

8. The sample size for the training set

Not applicable. No algorithm or AI is mentioned, so no training set.

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

Not applicable. No algorithm or AI is mentioned.

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The Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL ( Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.

The model 500H Doppler guided proctoscope consists of two parts . The first part is a Doppler probe in a proctoscope that are used integrally with each other and are not intended to be used separately. The Doppler guided proctoscope has a removable fiber optic light pipe, and a removable 8 mHz CW Doppler probe. The second part is a combination 8 mHz continuous wave (CW) Doppler detector with loudspeaker and a light source. The Doppler guided proctoscope is inserted in the rectum and rotated until one of the branches of the hemorrhoidal artery is located. The artery is located when the user hears the classical arterial blood flow sound. The Doppler guided proctoscope is rotated such that the arterial sound is maximized thus insuring that the hemorrhoidal artery is under the Doppler probe and in the Doppler guided proctoscope's rectangular slit. The physcician or surgeon can then ligate the artery . The Doppler guided proctoscope is then rotated until the next hemorrhoidal artery branch is detected. The process is repeated until all detected hemorrhoidal arteries are located and ligated. After ligation the Doppler guided proctoscope can be rotated 360 degrees to make sure that all of the hemorrhoidal arterial branches have been ligated.

The provided text describes a 510(k) submission for the Multigon Industries, Inc. Model 500H Doppler Guided Proctoscope. It does not contain a study with acceptance criteria and a detailed analysis of the device's performance against those criteria in a clinical setting.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The "Test Data" section is very brief and high-level, stating:

"The Model 500H Doppler guided proctoscope has been subjected to extensive safety, performance testing, and validation before release. Final testing of the 500H included various performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards."

This statement confirms that testing was done, but does not provide the specific acceptance criteria or the reported device performance in a way that can be tabulated.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for functional specifications and general safety are stated broadly as "met" and "complies with." Specific numerical targets for these (beyond acoustic output) are not provided in this document. The acoustic output section provides specific limits and measured values for the 500H, which are implicitly the acceptance criteria met by the device.

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

• Sample Size for Test Set: Not specified for functional or safety tests. For acoustic output, "Three probes were tested."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by the manufacturer.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, this document does not describe a MRMC comparative effectiveness study. This device is a guided proctoscope, not an AI-assisted diagnostic imaging interpretation device.

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

• Standalone Performance: Not applicable. The device is a physical instrument (proctoscope with a Doppler probe) used by a physician, not an algorithm. The document explicitly states "The 500H has no software or firmware associated with it."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not specified in detail for the functional and safety tests. For the acoustic output, the ground truth is the measured physical values against established standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware instrument and does not involve a training set in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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