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The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office.

The MedStar Monitoring System II comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The provided text lacks the detailed study information required to complete the table and answer all questions comprehensively. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and specific statistical results.

Here's an attempt to extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the "bench testing" mentioned suggests internal testing, not necessarily human patient data.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation.

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 MedStar System II is a data transfer device, not an AI-powered diagnostic tool used by human readers.

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

• Yes, implicitly. The "bench testing" mentioned would be a standalone evaluation of the device's technical performance (e.g., successful data transmission, accuracy of data transfer) without human intervention in its core function. However, specific results are not provided.

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

• For a data transfer device, the 'ground truth' would likely involve verifying the integrity and accuracy of the transmitted data against the original source data (e.g., verifying that a blood glucose reading of 'X' from the monitor is correctly received as 'X' by the server). The document does not specify the method used for this verification.

8. The sample size for the training set:

• Not applicable. This device is not described as using machine learning or AI that would require a training set.

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

• Not applicable, as there's no mention of a training set.

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The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.

The Datrix E-Tac EX-1000 (here simply: EX-1000) Electrocardiographic [ECG] Event Recorder is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Lightweight and compact, the EX-1000 is designed to be as non-intrusive as possible to the patient, and can operate up for 30 days on two AAA alkaline batteries. The patient's ECG data are acquired via patient leadwires (two-lead, one-channel). At the onset of an event, the patient presses the [Record] button to store his or her ECG data in the recorder's flash memory. Events are recorded according to one of four user-selectable memory configurations. Up to two events may be recorded before transmission of the data to a compatible receiving station is required. The patient initiates data transmission via telephone by removing the patient leadwires and pressing the [Send] button, upon which the stored data are transmitted. A physician or other qualified medical professional reviews the transmitted data. Feedback on the EX-1000 recorder status is provided to the user (technician and/or patient) via a multi-colored LED and audible tones.

Here's an analysis of the Datrix E-Tac EX-1000 Electrocardiographic Event Recorder's acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Datrix E-Tac EX-1000 are implicitly defined by its compliance with recognized performance standards and its substantial equivalence to predicate devices, particularly regarding amplitude and timing (frequency) reproduction of ECG signals.

Additionally, a detailed comparison to predicate devices showed:EX-1000: Amplitude reproduction was not significantly different or better than all other devices in 20 of 24 cases, and not significantly different or better than at least one device in 3 of 24 cases.Only 1 of 24 cases showed significant difference for EX-1000: This occurred for a 2.0mV and 0.5 Hz input signal with measurements from EKG Speaks™ software. For the same signal with GEMS™ Lite, it was substantially equivalent to the King of Hearts Express.The overall conclusion was that the performance of the Datrix EX-1000 was substantially equivalent or better than the three predicate devices with regards to amplitude reproduction in nearly all combinations tested. |
| Compliance with Safety Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971 (General requirements for safety, electromagnetic compatibility, and risk management). | Met: The device has been tested and conforms to IEC 60601-1, IEC 60601-1-2, and ISO 14971. This indicates it meets safety, EMC, and risk management requirements. |
| Software firmware considered "minor level" of concern and in compliance with FDA guidance and design controls (21 CFR 820.30, FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", ISO 14971, "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management"). | Met: The firmware was designed, documented, and validated in accordance with required device Design Controls and considered "minor level" of concern. Risks were analyzed per FDA guidance. |
| Substantial Equivalence to Predicate Devices (Overall comparison of features, specifications, and performance). | Met: The study concluded that the Datrix E-Tac EX-1000 is substantially equivalent to other predicate ambulatory ECG event recorders currently in commercial distribution, based on direct comparisons of performance (amplitude and timing reproduction) and detailed specification breakdowns in the provided tables. The device demonstrated performance that was generally equivalent or superior to the predicate devices. |

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

• Sample Size: A total of 24 in-house simulated events were recorded. These 24 events were then transmitted twice each (2 x 24 = 48 transmissions) to two different receiving stations.
• Data Provenance: The data was in-house simulated, meaning it was generated under controlled laboratory conditions rather than collected from actual patients.

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state that human experts were used to establish ground truth for this performance testing.
• Instead, the ground truth was based on "known input signals." This implies that the amplitude and frequency characteristics of the signals fed into the devices were precisely defined and known beforehand due to their simulated nature.

4. Adjudication Method for the Test Set

• There was no explicit adjudication method described for the test set in the traditional sense (e.g., 2+1, 3+1).
• Since the study used "known input signals" as the ground truth, the comparison was directly between the device's output and these pre-defined, objective reference signals. Measurements were taken from printouts, implying direct quantitative comparison rather than a qualitative human assessment requiring adjudication.

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

• No MRMC comparative effectiveness study was done. This study focused on the technical performance of the device itself (measurement accuracy) rather than its impact on human reader performance or diagnosis. The ECG data transmission is for a physician or qualified medical professional to review, but the study did not evaluate human interpretation.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was evaluated. The study measured the ability of the EX-1000 (and predicate devices) to accurately reproduce amplitude and timing/frequency of known input signals without human interaction in the measurement process (beyond setting up the simulation and taking measurements from printouts). The device's firmware handles the acquisition, storage, and transmission of data autonomously. The comparison was device-to-predicate and device-to-ground truth (known input signals).

7. Type of Ground Truth Used

• The ground truth used was based on precisely controlled and "known input signals." This is a form of objective, engineered ground truth where the exact characteristics (amplitude and frequency) of the test signals are defined prior to testing.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device appears to be a hardware-based event recorder with firmware, not a learning algorithm. The "firmware" was designed, documented, and validated according to design controls, implying traditional software engineering development and testing, not a dataset-driven training process.

9. How Ground Truth for the Training Set Was Established

• As there was no stated training set for a machine learning model, this question is not applicable. The device's functionality is based on its direct electronic processing of ECG signals according to its engineering design and firmware instructions.

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The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

The PER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The PER stores the ECG before and after the `record' button is depressed. The recording period is preset up to 80 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the PER

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a transtelephonic ECG event recorder (PER). It focuses on substantial equivalence to a predicate device, KING OF HEARTS® EXPRESS (K920984), rather than a detailed performance study with specific acceptance criteria that would include metrics like sensitivity, specificity, or accuracy derived from a test set and ground truth.

The document mentions:

• Comparison of Electrical Characteristics and Data Transmission: This indicates a comparison was done to show the PER's performance in these areas was equivalent or better than the predicate. However, it does not provide specific acceptance criteria or results in a table format.
• Summary of Safety: This references compliance with various safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2, AAMI EC11:1991). This confirms the device meets these standards, but these are general safety and performance standards for the device type, not specific acceptance criteria for a clinical study validating diagnostic accuracy.
• Risk Analysis: Discusses failure modes and mitigation, but not performance against clinical acceptance criteria.

Therefore, I cannot provide the requested table, sample sizes for test/training sets, details about expert ground truth, adjudication methods, MRMC studies, standalone performance, or how training ground truth was established, as this information is not present in the provided text.

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This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; Dizziness, Palpitations, Syncope, Chest pain.

The King of Hearts® Express + AF Monitor is an triggered cardiac event recorder designed for auto diagnostic evaluation of transient symptoms. The device uses a two-wire single channel lead set for event recording. Using looping memory, the device captures ECG data; auto triggering after the patient experiences a cardiac symptom or manually after the patient pushes the RECORD button. The number of Events can be physician adjusted according to the programmed lengths of Before and After data acquisition duration for each recording. These segments of stored ECG can then be transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is manually depressed. The device is configured in the same compact sized case approximately 4 inches long, 2 % inches wide and 5/8 " thick as the predicate devices. The two wire lead set is the same as is used in the predicate device [King of Hearts Express Monitor (K920984)}.

The provided text describes the "King of Hearts® Express + AF Monitor," and its 510(k) submission for FDA clearance. However, it does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, sample sizes for testing or training, ground truth establishment, or multi-reader multi-case study information.

The document primarily focuses on:

• Identifying the device and its intended use.
• Stating its equivalence to predicate devices.
• Highlighting the addition of atrial fibrillation (AF) detection as a key modification.
• Confirming that the modifications do not impact safety and effectiveness.

Therefore, I cannot fulfill the request for a detailed table and study description based on the provided input. The document explicitly states: "The King of Hearts Express + AF Monitor is Safety and Effectiveness: considered safe and effective for use when used in accordance with the instructions provided in the Owners Manual which accompanies each device. This device is a modification of previously cleared products currently manufactured by Instromedix. The only modifications are stated above. Based on these minor changes, there is no impact on safety and effectiveness." This indicates that extensive new studies for safety and effectiveness, beyond demonstrating the new AF detection feature, were likely not required for this 510(k) given the device's predicate status and the nature of the modification.

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