(308 days)
The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:
- Electronystagmography
- Visual evoked potentials,
- Auditory evoked potentials, and
- Electrical (somatosensory) evoked potentials.
The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and electrical. A thermal printer is built in, and laser printer connection is supported.
The provided text describes the Amplaid MK12, an evoked potential electrodiagnostic system, and its substantial equivalence to a predicate device, the Amplaid MK15. However, the document does not contain details about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically used for such studies in the context of AI/ML or a new, novel medical device.
The submission is a 510(k) for a device that is stated to be "similar in design and function" to a previously cleared device (K861014). The primary focus of the 510(k) summary is to demonstrate substantial equivalence, rather than to present a de novo performance study against explicit acceptance criteria.
Therefore, many sections of your request cannot be fulfilled by the provided text.
Here is an attempt to address your request based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device is "as safe and effective as the predicate device" through a comparison of characteristics.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Amplaid MK12) |
|---|---|---|
| Intended Use | Same as predicate device | Electronystagmography, Visual Evoked Potentials, Auditory Evoked Potentials, Electrical (Somatosensory) Evoked Potentials (Same as MK15) |
| Physical Characteristics (Size/Weight) | Comparable to predicate device | 21.25"H x 19.7"D x 7.9"H, 28.6 lbs (Different from MK15, but acceptable) |
| Energy Source | Same as predicate device | 115/230 Vac, ± 10%, 50-60 Hz (Same as MK15) |
| Hardcopy Output | Equivalent or improved functionality to predicate device | Built-in via 640 point thermal printer or laser printer connection (Improved/added functionality compared to MK15's computer interface output) |
| Electrical Safety | Compliance with UL-544, IEC 601 | UL-544, IEC 601 (Same as MK15) |
| Safety and Effectiveness | As safe and effective as predicate device | Reported as "as safe and effective as the predicate devices" based on "bench and user testing." |
| Technological Differences | Few and do not raise new questions of safety or effectiveness | Has "few technological differences" compared to the predicate. |
| New Indications for Use | None | No new indications for use. |
2. Sample size used for the test set and the data provenance
The document mentions "bench and user testing" but does not provide details on:
- The specific sample size (number of cases, subjects, or data points) used for this testing.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the testing mainly aimed to establish substantial equivalence based on safety and effectiveness comparable to a predicate, it's unlikely a formal "ground truth" establishment by multiple experts, as understood in an AI/ML context, was performed or detailed.
4. Adjudication method for the test set
This information is not provided 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
An MRMC study is not mentioned. The device is an evoked potential electrodiagnostic system and does not appear to be an AI-assisted diagnostic tool for human readers in the way an AI-powered image analysis system would be.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the device described. The Amplaid MK12 is a multi-channel system for electrodiagnosis, implying human operation and interpretation of the evoked potentials. It's not a standalone algorithm in the sense of AI/ML.
7. The type of ground truth used
The document does not specify the type of ground truth used. For an evoked potential system, "ground truth" would generally relate to the accuracy, reliability, and precision of the physiological signal acquisition and processing compared to established medical benchmarks or the performance of the predicate device.
8. The sample size for the training set
The concept of a "training set" in the context of machine learning is not applicable here, as the device is not described as using AI/ML algorithms that require training data.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).