(128 days)
Indications for use: 8 channel EMG amplifier
- To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
- To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system
- To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
- To measure relative (intra-patient) levels of activity of several muscles during a functional act
Indications for Use: 2 channel JVA amplifier
- To record and display sounds / vibrations from the temporomandibular joints
- To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the waveform in various standard plots (together with K981563)
- To aid the clinician in comparing a patient's current stand plots to previous recordings before, during and after treatment
- To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations, allowing intra-patient comparisons (only) by the clinician
The BioEMG III is a multi-channel electromyographic amplifier which includes; a) eight (8) identical high-gain differential input amplifiers, b) eight (8) identical opto-coupler isolation units and c) eight (8) ourput buffer amplifiers. The overall amplification of the BioEMG III is calibrated to 5000X. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3 dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The BioEMG III includes an isolated power converter that converts non-isolated +5 vdc into isolated + 5 and - 5 vdc. It may be connected to a personal computer through an analog to digital converter. Only three (3) functions are provided by the BioEMG III; I) amplification, 2) bandwidth limiting and 3) electrical isolation of the patient.
Analogous to the BioEMG II, the BioEMG III also incorporates two (2) additional inputs for recording vibrations from the left and right temporomandibular joints. They consist of: a) two (2) identical high-gain amplifiers and b) two (2) output buffer amplifiers. For these inputs no isolation is required because there is no electrical connection to the patient. The amplification is calibrated to 5000X and the bandwidth filtering is set from 30 Hz to 1000 Hz (± 3dB). These channels are also powered from an external +5 vdc non-isolated source, which is converted to +5 and -5 vdc. The vibration signals may also be connected to a personal computer through an analog to digital converter. The two (2) functions performed by these "JVA" channels include: 1) amplification and 2) bandwidth limiting.
The provided text is a 510(k) summary for the BioEMG III device. It focuses on demonstrating substantial equivalence to a predicate device (BioEMG II) through technological characteristics and non-clinical test data. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria in a clinical setting with human readers or a standalone algorithm.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, HRMR studies, ground truth details) cannot be extracted from this document as it primarily addresses regulatory submission for substantial equivalence based on technical specifications.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates performance by showing the BioEMG III retains the "same levels of amplification, isolation and band-pass filtering" as the predicate device (BioEMG II).
| Characteristic | Acceptance Criteria (Implied: Same as BioEMG II) | Reported Device Performance (BioEMG III) |
|---|---|---|
| Overall Amplification | 5000X | Calibrated to 5000X |
| Bandwidth Filtering (EMG) | 30 Hz to 1000 Hz (± 3 dB) | Set (fixed) from 30 Hz to 1000 Hz (± 3 dB) |
| Common Mode Rejection Ratio (EMG) | ≥ 130 dB at 50/60 Hz | ≥ 130 dB at the power line frequency (50/60 Hz) |
| Bandwidth Filtering (JVA) | 30 Hz to 1000 Hz (± 3dB) | Set from 30 Hz to 1000 Hz (± 3dB) |
| Isolation (EMG channels) | Electrical isolation of the patient | Electrical isolation of the patient |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not mentioned. The testing was non-clinical, using a function generator and oscilloscope.
- Data Provenance: Not applicable/Not mentioned. The testing was described as non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not mentioned. The "ground truth" was established purely through instrumental measurements against known calibration signals.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not mentioned. No human assessment or adjudication process was described for the non-clinical tests.
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
- MRMC Study: No. This device is an electromyograph and joint vibration amplifier, not an AI-powered diagnostic imaging tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a hardware amplifier; its performance is based on its electronic specifications (amplification, filtering, isolation) rather than algorithmic output. The non-clinical test data focused on these hardware characteristics.
7. The type of ground truth used
- Ground Truth Type: Calibrated function generator signals and oscilloscope readings. This represents a technical "ground truth" for electrical signal processing.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. As there's no training set, this is not relevant.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).