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The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers.

The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician.

The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician.

The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.

The provided text describes the H3+ Holter Recorder (K152626) and its substantial equivalence to a predicate device. However, a detailed study proving the device meets specific acceptance criteria with reported performance metrics is not included in this document. This submission primarily focuses on demonstrating substantial equivalence to a previous version of the H3+ Holter Recorder (K043010) by outlining technological characteristics and compliance with standards.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a table format with reported device performance for specific clinical metrics. Instead, it compares the current device (H3+ version 3.0.0) with its predicate device (H3+ version 2.09) across various technical specifications. The changes are largely related to increased recording duration, updated standards compliance, and minor hardware modifications. The statement "The H3+ was designed and tested for compliance with the applicable clauses of the following standards" implies that meeting these standards serves as the acceptance criteria for technical performance, but no specific performance values are reported against them in this document.

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 focuses on technical and regulatory compliance. It does not mention any specific sample size for a test set or clinical data. It explicitly states in Section 5, item 5: "The subject of this premarket notification did not require clinical data to support substantial equivalence." This implies that the testing performed was primarily non-clinical, focusing on engineering validation and adherence to standards. Therefore, information on data provenance (country, retrospective/prospective) is also not available.

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)

Since no clinical data or clinical test set was required for this submission, there is no information regarding the number of experts or their qualifications used to establish ground truth for a test set. The device's output (ECG data) is intended to be reviewed by "trained medical personnel for the purpose of forming a clinical diagnosis," suggesting that human experts interpret the device's output, but this is not part of the device's acceptance criteria study in this document.

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

As no clinical test set requiring adjudication was used for this submission, there is no information on any 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

This document describes a Holter recorder, which acquires, records, and stores ECG data. It explicitly states the device "performs no analysis by itself." Therefore, it does not incorporate AI and no MRMC comparative effectiveness study with or without AI assistance was performed or would be relevant to this device's function.

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

The H3+ Holter Recorder is a data acquisition and recording device. It "performs no analysis by itself." Therefore, there is no standalone algorithm performance to report. Its function is to capture data that will then be analyzed by a separate Holter analysis system, with the final interpretation by trained medical personnel.

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

For the technical performance evaluations mentioned (e.g., related to standards compliance), the "ground truth" would be established by the definitions and requirements specified within those engineering and medical electrical equipment standards. For instance, frequency response or signal resolution are directly measurable against predefined norms. Since no clinical claims were made or clinical data was required for this submission, there is no ground truth related to clinical diagnoses (expert consensus, pathology, or outcomes data) established or reported for the device itself.

8. The sample size for the training set

Since this device does not perform analysis and does not incorporate AI or machine learning algorithms, there is no training set used for the device itself.

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

As there is no training set for this device, information on how its ground truth was established is not applicable.

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The H12+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

• Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
• Evaluation of adult patients for ST segment changes .
• Evaluation of adult patients with pacemakers .
• Reporting of time domain heart rate variability .
• Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or . cardiac surgery.)
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients .
• Clinical and epidemiological research studies .
• Infant patient evaluation is limited to QRS detection only .

The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H12+ recorder. The H12+ utilizes a 10-lead electrode hookup and placement that will result in three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keyboard is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keyboard can be used to enter event markers.

H12+ has a large LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various warning messages for the hook-up technician.

H12+ uses one AA battery, and a removable Compact Flash card as a memory support.

This document is a 510(k) premarket notification for the Mortara H12+ Holter Recorder. It describes the device's intended use, indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on establishing that the H12+ Holter Recorder is substantially equivalent to a legally marketed predicate device (Mortara PR4 Holter analysis Recorder (K9110977), later named H-12), based on its design, intended use, and indications for use.

Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for device clearance, not a performance study report.

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The H3+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H3+ recorder and are undergoing Holter monitoring. The H3+ performs no cardiac analysis by itself and is intended to be used with the Mortara H-Scribe Holter analysis system (K004017) or other compatible Holter Analyzer. ECG data prerecorded by the H3+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Hotter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of 24 hours. The Mortara Holter Recorder H3+ is not a life-supporting device. It is diagnostic tool intended to acquire, record and store ECG data of patients requiring ambulatory (Holter) monitoring of 24 or 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

• Evaluation of adult patients with symptoms suggesting arrhythmia
• Evaluation of adult patients with pacemakers
• Reporting of time domain heart rate variability
• Evaluation of a patients response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• Clinical and epidemiological research studies
• Infant patient evaluation is limited to QRS detection only

The H3+ Holler Recorder is intended for use as part of a Holter Analysis system and is designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H3+ Holter Recorder provides two or three channels of continuous ECG data recorded over a 24-hour or 48-hour period.

The H3+ is a Holter Recorder offering micro-sized, extremely lightweight patient utility. Using existing Mortara approved technology, the H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H3+ recorder. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H3+ provides the ability to choose between a 3-Channel patient cable to record modified leads II, III and V; and a 2-Channel patient cable to record bipolar leads positioned according to clinician preference. The 3-Channel 5-lead patient cable allows for recording modified leads II, III and V. The 2-Channel 5-lead patient cable allows for recording two bipolar leads. Either patient cable can be used with the H3+ according to user preference. A LCD screen and Enter button allow for checking the lead quality during palient hook-up and starting the recording.

The H3+ uses a single AAA alkaline battery and stores acquired ECG data in internal, non-volatile memory. Stored ECG data will be downloaded for analysis to the H-Scribe, a PC based Holter Analysis system, via a standard USB interface. The recorded data will remain in memory until it has been cleared by the clinician.

The provided text describes a 510(k) notification for the Mortara H3+ Holter Recorder. However, it explicitly states that the H3+ Holter Recorder performs no cardiac analysis by itself. Its primary function is to acquire, record, and store ECG data. The analysis of this data is performed by the separate Mortara H-Scribe Holter Analysis system.

Therefore, the document does not contain information related to acceptance criteria for algorithmic performance, any accompanying study showing the device meets such criteria, or details regarding ground truth, expert adjudication, or reader studies as the H3+ device itself is merely a data acquisition and storage unit.

The provided text focuses on:

• Description of the Device: H3+ Holter Recorder, its features (2 or 3 channels, 24-hour or 48-hour recording, single AAA battery, internal non-volatile memory, USB interface).
• Intended Use: To acquire, record, and store ECG data for Holter monitoring, to be analyzed by the Mortara H-Scribe Holter Analysis system.
• Indications for Use: Evaluation of adults with suspected arrhythmia, pacemakers, heart rate variability, post-MI/cardiac surgery, therapeutic interventions, research studies. Infant evaluation is limited to QRS detection.
• Substantial Equivalence: Claimed against Mortara H12+ Holter Recorder (K021373), Ela Medical Spiderview (K032466), and Braemer / Phillips Digitrack Plus (K993617).

To address the request fully, it's important to reiterate that the H3+ is a data capture device, not an analytical one. The criteria and studies requested would be relevant for the H-Scribe Holter Analysis system (K004017), which performs the cardiac analysis, but not for the H3+ recorder itself.

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The Acuity system is intended to be used by skilled clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. The Acuity system consists of the Acuity® Central Monitoring Station. Acuity software, FlexNet™ communications network and Welch Allyn vital signs monitors. The vital signs monitors can operate standalone (according to their individual Intended Use Statement) or be networked to the Acuity central monitoring station through the Acuity FlexNet communication network.

In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.

• . Full Disclosure stores patient data for up to 96 hours.
• Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
• ST analysis module provides real-time monitoring and alarms for ST segment deviations, . from a reference beat, for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each detected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.

The most likely locations for patients monitored by an Acuity system are step-down units, telemetry departments, general med/surg floors and emergency departments. The Acuity system is available for sale only upon the order of a physician or licensed health care professional.

The Acuity system comprises four components: the Acuity Central Monitoring Station, Acuity software, the FlexNet™ communications network, and Welch Allyn vital signs monitors. The Acuity Central Monitoring Station is the heart of the system, using hardware provided by Sun Microsystems, Inc. The Acaity Central Monitation Station, Shippetwork devices on the FlexNet Betweek uring hardwired Ethernet connections (IEEE 802.3-compliant) or wireless Ethernet connections (IEEE 802.11compliant).

The Acuity software operating system is Solaris™, the Unix®-based operating system from Sun Microsystems. Welch Allyn Protocol's application software provides the routines and services required to accomplish the tasks associated with central patient monitoring. These tasks include the user interface, communication with patient monitors, management of alarms and settings, and recording and review of patient data.

The Archythmia Analysis and ST Analysis options are being replaced with Mortara Instrument's arrhythmia algorithm software module. Mortara Instrument's arrhythmia software will now provide the data analysis for both the Arrhythmia Analysis and the ST Analysis options.

The Acuity application software receives the output from the Mortara software module and records the results in the same manner as the previous version of Acuity software. There are only a few minor changes to the user interface as described in the Acuity Directions For Use.

The Acuity hardware and software operating system are not changed.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a formal table with pass/fail thresholds. However, it implicitly sets performance expectations by comparing the new software module to the previous one and by presenting specific performance metrics from a standalone test.

Implicit Acceptance Criteria and Reported Performance:

Study Details

The document describes performance testing conducted to evaluate the new Mortara arrhythmia software module within the Acuity system.

2. Sample Size and Data Provenance:

• Test Set Sample Size: "one test case, which included 1600 beats". This refers to the specific instance where 3 ventricular beats were mislabeled. The document also mentions "playback files" being used, suggesting a standardized set of ECG recordings.
• Data Provenance: Not specified, but the use of "playback files" implies pre-recorded data, likely retrospective. There is no mention of country of origin.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document does not describe how the ground truth for the test playback files was established or who established it.

4. Adjudication Method:

• Adjudication Method: Not specified.

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

• Was it done?: No. The study focuses on the performance of the algorithm itself and mentions the improvement of the Mortara software module over the prior Acuity software module. It does not describe human readers using the AI-assisted system and comparing their performance to human readers without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Was it done?: Yes. The text explicitly states: "A standalone (non-networked) Acuity system with a single patient monitor connected was also tested with the same playback files." This represents a standalone evaluation of the algorithm's performance.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated, but based on the context of "playback files" and evaluating arrhythmia detection and labeling, the ground truth would most likely be expert consensus on ECG interpretations or potentially derived from established, adjudicated databases of ECG recordings. The document doesn't provide enough detail to definitively confirm this, but it is implied by the nature of arrhythmia analysis.

8. Sample Size for the Training Set:

• Sample Size: Not specified. The document focuses on the testing of the Mortara module within the Acuity system, not on the development or training of the Mortara algorithm itself.

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

• How Established: Not specified. As with the training set size, this information pertains to the development of the Mortara algorithm, which is not detailed in this submission.

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The H12+ Holter recorder is intended to acquire, record and store up to 24 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of 24 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

• Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
• Evaluation of adult patients for ST segment changes •
• . Evaluation of adult patients with pacemakers
• . Reporting of time domain heart rate variability
• . Evaluation of a patients response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
• . Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• . Clinical and epidemiological research studies
• . Infant patient evaluation is limited to QRS detection only

The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H12+ utilizes a 10-lead electrode hookup and placement to provide the H-Scribe system with three channels of full disclosure for Holter analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keypad is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers.

H12+ has a LCD screen to allow ECG display during the hook-up. lead quality check. system configuration and various messages for the hook-up technician.

H12+ uses one AA battery, and a removable memory card for data storage.

This document does not contain the information required to populate the requested tables and descriptions regarding acceptance criteria and study results. The provided text is a 510(k) summary for a Holter Recorder (H12+), which focuses on device description, intended use, indications for use, and regulatory substantial equivalence to a predicate device. It does not include:

• Specific acceptance criteria for device performance (e.g., accuracy metrics for ECG acquisition).
• Details of a study proving the device meets acceptance criteria.
• Information on sample size, data provenance, ground truth establishment, or expert involvement for any performance study.
• Mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.

The document states that the H12+ "performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017)." This indicates that the H12+ is a data acquisition device, and therefore, performance metrics related to cardiac analysis would likely be evaluated for the H-Scribe system, not the H12+ recorder itself.

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