(273 days)
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.
The provided text describes a 510(k) premarket notification for a neuromuscular stimulator (BMLS03-3) and does not contain detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for performance claims of AI/ML or diagnostic devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as a set of quantified performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) for clinical or diagnostic outcomes.
The "acceptance criteria" here implicitly revolve around demonstrating functional equivalence based on device specifications to the predicate devices.
Acceptance Criteria (Implied from Substantial Equivalence Claim):
- Output Pulse Strength Equivalence: The BMLS03-3's output pulse strength must be equivalent to that of the BMLS03-1 predicate device.
- Other Device Parameters: The BMLS03-3 must be identical to the BMLS02-5 predicate device in all other aspects (e.g., waveform, pulse rate, pulse width, intensity range, modes, display).
Reported Device Performance (from "Comparison to Predicate Device"):
| Specific Acceptance Criteria | Reported Device Performance |
|---|---|
| Output Pulse Strength (relative to BMLS03-1) | "The output pulse strength of the BMLS03-3 is equivalent to the predicate (BioMedical Life Systems, Inc.) BMLS03-1." |
| Identity to BMLS02-5 (excluding output pulse strength) | "The BMLS03-3 is identical to the predicate (BioMedical Life Systems, Inc.) BMLS02-5 device in every way except for output pulse strength." |
| Clinical Effectiveness for Listed Indications (e.g., muscle reeducation, disuse atrophy) | Not applicable. No clinical studies were performed. The device's clinical effectiveness is presumed based on the predicate device's established use. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical "test set" in the context of patient data was used. The testing was limited to "bench testing" of the physical device.
- Data Provenance: Not applicable, as no human data was used for testing. The "bench testing" would involve laboratory measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no ground truth for a test set established by experts, as no clinical or diagnostic performance was being evaluated. The equivalence was determined through engineering bench tests.
4. Adjudication method for the test set
- Not applicable. No adjudication method was used, as there was no test set requiring expert review or consensus.
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 a medical device (neuromuscular stimulator), not an AI/ML or diagnostic imaging device. Therefore, MRMC studies and "human readers" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluated the device's physical output characteristics.
7. The type of ground truth used
- The "ground truth" for the equivalence claim was based on measurements from bench testing comparing the physical output characteristics (specifically pulse strength) of the BMLS03-3 directly against the BMLS03-1 predicate device, and other parameters against the BMLS02-5 predicate device. It's not a clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that employs a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
Summary of the Study:
The "study" to prove the device meets acceptance criteria was non-clinical bench testing.
- Methodology: The BMLS03-3 was directly compared to two predicate devices:
- BMLS02-5: The BMLS03-3 was found to be "identical in every way" except for output pulse strength.
- BMLS03-1: The output pulse strength of the BMLS03-3 was determined to be "equivalent" through bench testing.
- Purpose: To demonstrate that the new device (BMLS03-3) is substantially equivalent to legally marketed predicate devices, thereby allowing it to be cleared for market without requiring new clinical trials.
- Conclusion: Based on the bench testing, the FDA determined the device to be substantially equivalent to the predicate devices for the stated indications for use. No clinical trials were deemed necessary, as explicitly stated in the document ("Clinical Testing: Not applicable.").
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).