(164 days)
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.
| Feature | Predicate Device (H3+ version 2.09) | Current Device (H3+ version 3.0.0) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Indications for Use | Max 48 hours for adult patients | Max 14 days for all patient populations | Equivalent, expanded patient population and use environment | Achieved (stated as equivalent in terms of functionality) |
| Record Duration | 24 and 48 Hours | Up to 14 days | Equivalent technology but larger storage capacity | Achieved: Up to 14 days |
| Channels | 2 or 3 | 3 | Removed 2-channel functionality (still considered equivalent) | Achieved: 3 channels |
| Sampling Rate | 180 sps | 180 sps | Identical to predicate | Achieved: 180 sps |
| Frequency Response | Meets ANSI/AAMI EC38 requirements | Meets IEC 60601-2-47 requirements | Equivalent (meeting updated standard) | Achieved: Meets IEC 60601-2-47 requirements |
| Dynamic Range Amplitude | 12-bit | 12-bit | Identical to predicate | Achieved: 12-bit |
| Digital Resolution | 6.25 uV | 6.25 uV | Identical to predicate | Achieved: 6.25 uV |
| Power (battery life) | 1 AAA Alkaline battery up to 48 H | 1 AAA Alkaline battery up to 14 days | Equivalent (implied improved battery life for extended recording) | Achieved: Up to 14 days |
| Pacemaker Detection | Yes | Yes | Identical to predicate | Achieved: Yes |
| Compliance with Standards | (Implied compliance with relevant standards) | IEC 60601-1, IEC 62304, IEC 60601-2-47, IEC 60601-1-2 | Full compliance with listed standards | Document states "designed and tested for compliance" (achieved) |
| Software Validation | (Implied prior validation) | Yes | Meet all design inputs and performance requirements | Document states "undergone software validation" (achieved) |
| Performance Verification/Validation | (Implied prior verification/validation) | Yes | Ensure it meets all design inputs and performance requirements | Document states "performance verification and validation" (achieved) |
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.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).