(79 days)
The Model 950-12L Holter recorder is intended to record continuous data for up to 120 hours for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as:
- Palpitations, shortness of breath, chest pain, syncope
- Evaluating pacemakers
- Heart rate variability's
- Evaluating medications
- Clinical studies
This is a prescriptive device and is to be used by trained physicians and other licensed medical professionals only.
The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations.
The Memtec Model 950-12L recorder is not intended for infants weighing less than 22 Lbs. (10 Kg).
The Model 950-12L is a small, light weight, single battery device designed for the recording of ECG data collected from ambulatory patients. The device can record and store multiple of channels of data for up to 120 hours on a SD Card. The device has a resolution of 12-bits with a fundamental sampling frequency of 6K (SPS) per channel with selectable storage rates of 128, 256, 512, or 1024 SPS and is stored un-compressed on a removable SD or SDHC Storage Card. The data can be downloaded via USB 2.0 or removable of SD Card. Data integrity is provided by including Patient ID/Date/Time Stamps and a CRC-16 check on the recording every 2 minutes. The large LCD provides real time patient ECG signals enabling lead placement confirmation during patient hook-up. The Model 950-12L provides up to 48 hours of continuous operation using one AA alkaline or 120 hours using a Lithium "AA" battery.
The recorder is not capable of any diagnosis, nor can it provide any interpretation of the data. The device accommodates compatibility with various OEM Holter playback systems.
The provided document is a 510(k) summary for the Memtec Model 950-12L Holter Monitor, which is a device for recording ECG data. The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and general safety and effectiveness.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of algorithm performance.
The device itself is described as a "Holter Monitor (Without Analysis)" and explicitly states: "The recorder is not capable of any diagnosis, nor can it provide any interpretation of the data." and "The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations."
Therefore, many of the requested points in your prompt are not applicable to this type of device and submission. This is a hardware device intended for data acquisition, not an AI or algorithm-driven diagnostic tool.
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
-
Acceptance Criteria: The document implies that the acceptance criteria are adherence to specific industry standards for medical devices and performance equivalent to existing predicate devices. No quantitative performance metrics for disease detection or diagnosis are presented because the device does not perform these functions.
- Standards Cited:
- ANSI/AAMI EC38 (Performance standard for cardiac monitors, heart rate meters, and alarms)
- IEC60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests)
- IEC61000-4-2, 3, 6, and 8 (Electromagnetic compatibility (EMC) testing standards)
- Standards Cited:
-
Reported Device Performance: The "Conclusions From Non-clinical Testing" state: "After comparing predicated devices to the Memtec Model 950-12L, results show that with the intended use, the Model 950-12L is equivalent in safety and effectiveness." This is a qualitative statement of equivalence based on meeting the mentioned standards, not a quantitative performance metric for diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. The device does not perform diagnostic algorithms, so there is no "test set" of patient data in the context of evaluating algorithm performance for disease detection. The testing mentioned (non-clinical) would involve device-level electrical, mechanical, and safety testing, not clinical data sets for diagnostic accuracy evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. See point 2. There's no ground truth for diagnostic performance established for this device as it doesn't make diagnoses.
4. Adjudication Method for the Test Set
- Not Applicable. See point 2.
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-assisted diagnostic device. It's a data recorder.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. There is no diagnostic algorithm in this device.
7. The Type of Ground Truth Used
- Not Applicable. For a device without diagnostic capabilities, "ground truth" related to disease outcomes or pathology is not relevant to its 510(k) submission. The "ground truth" in this context would be whether the device meets electrical safety, EMI/EMC, and recording performance specifications as defined by the cited standards.
8. The Sample Size for the Training Set
- Not Applicable. There is no machine learning "training set" for this hardware device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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).