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510(k) Data Aggregation
(198 days)
BASBA E-MACHINE
The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Basba E-Machine is a non-invasive, transcutaneous electrical stimulation device, which is intended for use as an adjunctive treatment for individuals suffering from chronic intractable pain. The system consists of a.TENS Unit, AC-DC adapter to power the unit and a serial RS-232 connection cable. The Unit is approximately 17 cm x 15 cm x 4 cm. Two light emitting diodes (LED) are located on the faceplate of the Unit. The green LED indicates the working status of the device and the red LED is the power indicator. There are four sockets located on the faceplate of the Unit: three of them labeled "OUT" provide the output electrical current for 3 different types of connectors and the fourth socket is the ground socket labeled GND.
The Basba E-Machine is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The provided document is a 510(k) premarket notification summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting an efficacy study with acceptance criteria and performance data in the typical sense of a clinical trial.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly filled from this document. This submission primarily relies on comparing technical characteristics and intended use to already cleared devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific acceptance criteria or performance metrics (e.g., pain reduction scores, percentage of users experiencing relief) in a quantifiable manner as would be expected from a clinical efficacy study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technical, functional, and performance characteristics to existing predicate devices.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Safety: Device operates without raising new safety concerns. | "The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." Functional performance testing and electrical safety testing were conducted. |
| Functional Performance: Operates as intended for a TENS device. | "The Basba E-Machine has comparable technical and performance characteristics as currently marketed TENS devices." "The E-Machine and the referenced predicate devices use similar electronic components to provide electrical stimulation via paired electrodes to the subject. All of these devices are operated at continuous wave duty cycles." |
| Efficacy: Performs comparably to predicate TENS devices for intended use. | "The Basba E-Machine is designed to comply with the generally accepted performance specifications for TENS devices." "The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." It has the "same intended uses and similar technical, functional and performance characteristics" as predicate devices. |
| Electrical Safety: Compliant with relevant standards. | Electrical safety testing was conducted. (Specific standards or results not detailed in this summary.) |
| Intended Use: Matches predicate devices for pain relief. | "The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain." This matches the general intended use of predicate TENS devices. |
2. Sample Size for Test Set and Data Provenance
The document describes functional performance and electrical safety testing of the device itself, but does not describe a clinical study on a human test set. Therefore, information like sample size, country of origin, or retrospective/prospective nature for clinical data is not applicable or provided.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission does not involve expert-adjudicated ground truth from a clinical study.
4. Adjudication Method
Not applicable. This submission does not involve clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than a direct comparative clinical trial against a "without AI" arm.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is not an algorithm or AI system. It's a physical TENS device. The performance described (functional and electrical safety testing) is inherently "standalone" in the sense that it refers to the device's own operation.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is primarily the technical specifications and established safety/efficacy profiles of the predicate devices. The Basba E-Machine's tests (functional performance and electrical safety) demonstrate its compliance with, and similarity to, these established benchmarks. There is no biological or clinical "ground truth" established for individual cases as would be found in diagnostic device studies.
8. Sample Size for Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable. No training set for an AI/ML algorithm is involved.
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