(179 days)
The Amplaid MK22 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 MK22 Multi-channel system for electrodiagnosis consists of a two 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 Amplaid MK22 is an evoked potential electrodiagnostic system. The submission establishes substantial equivalence to the Amplaid MK15 (K861014).
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the acceptance criteria are based on substantial equivalence to the predicate device, Amplaid MK15. This means the new device must be as safe and effective as the predicate device and have the same intended uses, with no new indications for use. Performance is implicitly assessed by demonstrating that the key characteristics of the new device are either identical or comparable to the predicate device and that any differences do not raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Predicate Device: Amplaid MK15) | Reported Device Performance (New Device: Amplaid MK22) |
|---|---|---|
| Intended Uses: | Electronystagmography, Electroneurography, Visual evoked potentials, Auditory evoked potentials, Electrical (somatosensory) evoked potentials | (Same) Electronystagmography, Electroneurography, Visual evoked potentials, Auditory evoked potentials, Electrical (somatosensory) evoked potentials |
| Physical characteristics: | ||
| Number of channels | 2 or 4 | 1 or 2 (Difference noted, but acceptable as it's a reduction in channels, not an increase in complexity or new functionality requiring more channels than available) |
| Size/weight | 20.8" W x 18.9" D x 13.4" H, 44 lbs. | 10" W x 14" D x 14" H, 22.2 lbs (Smaller and lighter, considered an improvement or neutral difference) |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | 95-250 VAC, 50-60 Hz 100 VA (Wider voltage range, acceptable as it signifies wider compatibility without compromising safety) |
| Display | CRT monochrome (green), 9" | CRT, monochrome (green), 9", 640 x 400 (Same) |
| Hardcopy Output: | Built in via 640 point thermal printer or laser printer connection | (Same) Built in via 640 point thermal printer or laser printer connection |
| Standards and Safety characteristics: | ||
| Electrical safety: | UL-544, IEC 601, Type BF | (Same) UL-544, IEC 601, Type BF |
| Conclusion: | The predicate device is safe and effective, with established performance for its intended uses. | The new device is as safe and effective as the predicate device, has fewer channels (which is not a new safety/effectiveness concern), and has no new indications for use, thus rendering it substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical performance study with human subjects or a defined set of data for algorithm evaluation. The assessment for this 510(k) is based on bench and user testing and a comparative analysis of specifications against the predicate device.
- Sample Size: Not applicable in the context of a traditional performance study. The evaluation focuses on the device hardware and software specifications, and its equivalence to a previously cleared device.
- Data Provenance: Not specified as there isn't a clinical data set being referenced for performance evaluation. The "bench and user testing" information is general and does not refer to specific patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This 510(k) submission is for an electrodiagnostic system, and its clearance is based on substantial equivalence to a predicate device, not on diagnostic accuracy against a ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. There is no specific "test set" and corresponding adjudication process described for evaluating device performance in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC comparative effectiveness study was not performed or referenced in this 510(k) submission. The device is an electrodiagnostic system and the clearance pathway relies on demonstrating equivalent technical specifications and intended uses to a predicate device, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Amplaid MK22 is a medical device (an electrodiagnostic system) that acquires and processes physiological signals for medical diagnosis by a clinician. It is not an AI algorithm that produces a diagnostic output on its own. While it involves signal averaging, storage, and display, this is part of standard electrodiagnostic equipment functionality, not an AI algorithm performing diagnostic interpretation without human input.
7. The Type of Ground Truth Used
Not applicable. The submission does not refer to a ground truth for diagnostic accuracy, as it focuses on demonstrating the device's technical specifications and intended uses are substantially equivalent to a predicate.
8. The Sample Size for the Training Set
Not applicable. The Amplaid MK22 is a hardware and software system for electrodiagnosis; it is not an AI algorithm that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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).