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Hokanson Digit and Penile cuffs are intended to measure blood pressure in small peripheral body parts. In general, the width of a blood pressure cuff should be approximately 40% of the diameter of the limb or digit being measured. The length of the cuff, in the case of these devices, is long enough to completely encircle the object being measured. The usage is the same as the predicate device which has been manufactured by our company since 1973.

Hokanson Blood Pressure Digit and Penile cuffs

I am sorry, but to answer your request with the specific details about acceptance criteria, device performance, and study information, I would need a clinical study report or a 510(k) summary that contains such data.

The provided document is an FDA 510(k) clearance letter for the "Hokanson Blood Pressure Digit and Penile Cuffs." This letter primarily:

1. Confirms substantial equivalence: It states that the device is substantially equivalent to legally marketed predicate devices.
2. Specifies the regulation number and class: It classifies the device as a Class II blood pressure cuff.
3. Lists the indications for use: It states that the cuffs are intended to measure blood pressure in small peripheral body parts.

However, this document does not contain:

• Acceptance criteria or reported device performance data.
• Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication method, MRMC studies, or standalone performance).
• Information about the training set.

Typically, this kind of performance data and study design would be found in the 510(k) summary submitted by the manufacturer, which is often a separate document from the clearance letter itself.

Therefore, I cannot provide the requested table and detailed study information based solely on the text you provided.

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This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

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

This information is not present in the document. Since a specific performance study with a test set is not described, these details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

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

This information is not present 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:

This information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

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

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

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

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

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

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

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The intended use of the Al6 is the measurement of arterial blood flow by means of venous occlusion plethysmography. The Al6 replaces the predicate instruments which are used primarily in research studies. Applications include studies that relate to protocols that influence limb blood flow through exercise, reactive hyperemia, or the influence of drugs.

The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.

The Al6 Blood Flow Measuring system measures blood flow in one or two limbs or digits simultaneously using the principles of venous occlusion plethysmography. This involves inflating a blood pressure cuff on the proximal part of the limb to a pressure that exceeds the venous pressure in the limb, but which is less than the arterial pressure. The cuff inflation is done quickly so as to obtain a distinct starting point for the measurement. When the cuff is inflated the limb begins to swell due to the blood flowing into the limb since the normal venous outflow is stopped by the cuff. The resulting change in the volume of the limb is measured by the plethysmographs and the rate of change is equal to the blood flow at the moment of venous occlusion. The Al6 is controlled by a computer program that causes the cuff inflators to inflate, records the plethysmographic volume measurements and calculates the rate of change of volume. By combining the instruments and controlling them with one computer it is possible to make measurements in quick succession and more easily analyze the results.

The provided documentation describes the Hokanson Blood Flow Measuring System (AI6), but it does not contain a typical acceptance criteria table with reported device performance metrics against specific thresholds. Instead, the submission focuses on demonstrating equivalence to predicate devices through comparisons of key components and their performance.

Here's a breakdown of the requested information based on the provided text, highlighting where information is present and where it is absent:

1. Table of acceptance criteria and the reported device performance

As mentioned, a formal table of acceptance criteria with specific performance metrics and their corresponding thresholds is not present in the provided document. The submission assesses performance relative to predicate devices.

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

This information is not provided in the document. The submission describes bench testing and comparisons to predicate devices, not studies involving human subjects or specific data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The evaluation described is based on engineering and performance characteristics of components, not on expert-adjudicated ground truth from a test set of medical data.

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

This information is not applicable/provided. There is no mention of a test set requiring adjudication in the context of this submission.

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

A MRMC study was not conducted. This device is a measurement system and does not involve AI assistance for human readers or interpretation of medical images.

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

This is a physical medical device (Blood Flow Measuring System) that performs measurements. While it is computer-controlled, it's not an "algorithm only" device in the sense of an AI diagnostic tool. The description focuses on its standalone measurement capabilities as equal to combined predicate devices. Therefore, the functional performance of the device itself can be considered standalone, but it's not an AI algorithm.

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

The "ground truth" for this submission is based on physical constants, engineering specifications, and the established performance of the predicate devices. For example, pressure accuracy is measured against a known standard (mmHg), and inflation speed is measured against a known time (mSec). The core claim is that since the components and their performance are equivalent to legally marketed predicate devices, the new device is also safe and effective.

8. The sample size for the training set

This information is not applicable/provided. This device does not use machine learning or AI algorithms that require a "training set."

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

This information is not applicable/provided as there is no training set for an AI algorithm.

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The EC6 is two plethysmographs in one. A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

The EC6 is two plethysmographs in one. A mercury strain gauge plethysmograph accurately measures volume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse volume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared photo plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes and measure blood pressure in the extremities in conjunction with blood pressure cuffs.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding the substantial equivalence of the "EC6 Plethysmograph" to legally marketed predicate devices, and an "Indications for Use" statement. It does not contain details about performance studies, sample sizes, ground truth establishment, or expert qualifications.

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The ANS2000 is an ECG Monitor and Respiration Pacer that measures heart rate and provides a respiration timer for the purpose of measuring heart rate variations in response to respiration. The measuring board is used in studies of patients in which it is important to know the interval between heartbeats and also to have analysis with the patient's breathing.

The ANS2000 is an ECG Monitor and Respiration Pacer.

The provided text is a 510(k) premarket notification letter from the FDA to D.E. Hokanson, Incorporated, regarding their ANS2000 ECG Monitor and Respiration Pacer. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory letter indicating that the device has been found substantially equivalent to a predicate device for its stated indications for use.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report.

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NIVP3 is a computer program which is used with Hokanson vascular diagnostic instruments and an IBM compatible personal computer to produce comprehensive reports. These reports are stored in a computer database and may be sorted, retrieved, and printed. The program allows the user to select and record plethysmographic and Doppler waveforms and blood pressure measurements .. Patient demographics and history are also stored by the program. The user may enter comments to enhance the report.

Safety and effectiveness of NIVP3 are equal or better than for NIVP. The same non-invasive diagnostic instruments are used to provide data inputs to the computer. These are the MD35 Procord (K896034), the TL400 Totalab (K872517), the EC5R Plethysmograph (K932812), and the TD312 Calculating Cuff Inflator K842067). In each case optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument. Data is collected by the computer and incoming waveforms are displayed on the computer screen. The user selects the data to be retained and may edit decision points by moving cursors on the screen. The data is stored in a database using the ACCESS® database engine. A run-time version of ACCESS® is furnished with the program.

No diagnostic decisions are made by the program. The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports. The advantages of using NIVP3 are that reports are neat and uniform and that patient records are easily stored and retrieved. In some cases tests, like arterial inflow, are semi automated since the program can perform some functions such as inflate a cuff or balance and calibrate the plethysmograph at the correct time to facilitate data collection. Extensive use is made of the Windows® help system to aid the user in operation of the program and give instructions on how to perform certain diagnostic tests.

The provided text describes the 510(k) submission for the NIVP3 Non-Invasive Vascular Program. However, it does not contain specific acceptance criteria or details of a study designed to prove the device meets such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device, NIVP, rather than providing a detailed performance study with acceptance criteria.

Here's how to address each point based on the provided text, highlighting what is not available:

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

• Uses non-invasive diagnostic instruments (MD35 Procord, TL400 Totalab, EC5R Plethysmograph, TD312 Calculating Cuff Inflator) to collect data.
• Displays incoming waveforms on the computer screen.
• Allows user to select and retain data, and edit decision points by moving cursors.
• Stores data in an ACCESS® database.
• Produces neat, uniform, and easily retrievable reports.
• Semi-automates some tests (e.g., arterial inflow: inflates cuff, balances/calibrates plethysmograph).
• Employs optical isolation to prevent electrical leakage. |
  | Device safety (e.g., electrical safety) | "Optical isolation is employed to prevent electrical leakage from a computer power supply from reaching the diagnostic instrument, and from there being able to reach a patient. There is no direct electrical connection from the computer to the diagnostic instrument." |
  | Device effectiveness (in terms of increasing technologist efficiency) | "The program is not intended to replace the need for a skilled vascular technologist, but is intended to increase the technologist's efficiency by eliminating the need for cutting out chart recordings and writing extensive reports." |

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. The document does not describe a specific test set or clinical study with a defined sample size for evaluating the NIVP3's performance against detailed acceptance criteria. The focus is on the device's functional equivalence and safety features.

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 applicable / Not provided. Since no specific test set or clinical study with ground truth establishment is described for NIVP3, this information is not available. The program's design explicitly states: "No diagnostic decisions are made by the program." and "The program is not intended to replace the need for a skilled vascular technologist." This indicates that the program is a data management and reporting tool, not an AI/diagnostic aid that would require ground truth for diagnostic accuracy.

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

• Not applicable / Not provided. As no test set for diagnostic performance is described, there's no adjudication method mentioned.

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. An MRMC study was not done. The NIVP3 is described as a software program to assist vascular technologists with data collection, storage, and reporting, aiming to increase efficiency. It does not perform diagnostic decisions or offer "AI assistance" in the modern sense that would lend itself to an MRMC study comparing human performance with and without an AI algorithm.

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

• Not applicable. The NIVP3 is explicitly designed as a human-in-the-loop system. The user selects data to retain, edits decision points, enters comments, and makes diagnostic decisions. The program itself does not make diagnostic decisions in a standalone capacity.

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

• Not applicable / Not provided. As the device is not making diagnostic claims or predictions, there is no discussion of ground truth in the context of diagnostic accuracy. The ground truth for the data it handles would be the measurements and waveforms captured by the connected diagnostic instruments, which are then reviewed and interpreted by a skilled vascular technologist.

8. The sample size for the training set

• Not applicable / Not provided. The NIVP3 is a software application for data management and reporting, not an AI or machine learning algorithm that requires a "training set" in the conventional sense to learn patterns or make predictions. Its functionality is based on predefined logic for data handling, display, and reporting.

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

• Not applicable / Not provided. No training set is mentioned for this type of software.

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