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The Stella BIO is a neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions

As a powered muscle stimulator, Stella BIO is indicated for the following conditions:

· Relaxation of muscle spasms,
· Prevention or retardation of disuse atrophy,
· Increasing local blood circulation,
· Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
· Maintaining or increasing range of motion,
· Muscle re-education.

As a transcutaneous electrical nerve stimulator for pain relief. Stella BIO is indicated for the following conditions:

· Symptomatic relief and management of chronic (long-term), intractable pain,
· Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.

As a biofeedback device, Stella BIO is indicated for:

· Biofeedback, relaxation and muscle re-education.

As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: · Helps to relearn voluntary motor functions of the extremities.

As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions:

· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.

· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.

Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.

Environments of Use: Clinics, hospital and home environments.

Platform: Stella BIO is a battery-powered, wireless device, accessible through software.

Device Description

The Stella BIO is a neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device, designed for stationary use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient.

Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.

For the Prescription and Home Use by prescription from a medical professional Software License, the medical professional has the ability to adjust, monitor and progress the therapy. This License comes with two User Manuals:

User Manual for the medical professionals (including instructions on how to adjust parameters ● of the programs and prescribe exercises for patients)
User Manual for the patient (including instruction on how to use programs prescribed and adjusted by the medical professional)

The Stella BIO is a battery-powered, wireless device, accessible through software on a mobile device (PC, tablet or smartphone). Statistics reqarding the completed treatment can be retrieved from the PC.

In order to gain a proper understanding of Stella BIO, it is important to read the manual before beginning to use the Stella BIO.

AI/ML Overview

This document is a 510(k) summary for the Stella BIO device, which is a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. The purpose of this summary is to demonstrate that the Stella BIO device is substantially equivalent to a legally marketed predicate device, the Stiwell med4 (K080950).

Key Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the Stella BIO to its predicate device across various "designations" (Powered Muscle Stimulator, Functional Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, Incontinence Programs, Biofeedback). Instead of defining explicit acceptance criteria with numerical targets as one might for a diagnostic AI, the acceptance criteria here are implicitly met by demonstrating that any differences between the new device and the predicate device, or adherence to relevant voluntary standards (IEC, ANSI/AAMI, FDA guidance), do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" table below is constructed by extracting the key comparative metrics and the conclusions drawn regarding their impact on safety and effectiveness.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (Implicit)	Reported Stella BIO Performance	Conclusion of Impact on SE (Safety/Effectiveness)
General Characteristics
Power Source	Must not influence essential performance or basic safety, and still align with substantial equivalence to predicate.	Battery Pack Li-Ion 7,4 V (Predicate: 11,1 V). Compliant with IEC 62133, IEC 60601-1. Battery operated, so no line current isolation needed.	Does not influence essential performance or basic safety, nor impact substantial equivalence.
Number of Output Modes	Must comply with IEC 60601-1 and IEC 60601-2-10 requirements.	4 (EMS, TENS, Biofeedback, Incontinence) (Predicate: 1).	Does not impact essential performance, basic safety, or substantial equivalence.
Compliance with Voluntary Standards	Must comply with recognized FDA standards and not raise new safety/effectiveness questions.	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304, IEC 62366, IEC 62133, ANSI/AAMI NS4 (Predicate: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). Additional standard ANSI/AAMI NS4.	Does not impact essential performance, basic safety, or substantial equivalence.
Weight & Dimensions	Compliance with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-11 requirements.	Weight: 112 g (Predicate: 440 g). Dimensions: 91.5 x 68.4 x 24 mm (Predicate: 175 x 95 x 30 mm).	Differences do not raise any safety or effectiveness issues.
Powered Muscle Stimulator (PMS)
Treatment Time Range	Compliance with IEC 60601-1 and IEC 60601-2-10.	1 - 60 min (Predicate: 2 - 120 min).	Does not impact essential performance, basic safety, or substantial equivalence.
Number of Output Channels	Compliance with IEC 60601-1 and IEC 60601-2-10.	Up to 8 (Predicate: 4).	Does not impact essential performance, basic safety, or substantial equivalence.
Waveform Shape	Electrical stimulation for all waveforms must be safe and compliant with IEC 60601-2-10.	Rectangular, triangular, trapezoidal, sinusoidal (Predicate: Rectangular). New shapes are safer due to lower maximal phase charge, current density.	Does not impact essential performance, basic safety, or substantial equivalence.
Max Output Voltage/Current	Compliance with IEC 60601-2-10.	Varied (e.g., Max Output Voltage (2kΩ): 60 V vs 115 V for predicate; Max Output Current (2kΩ): 30 mA vs 50 mA for predicate). All tested and compliant.	Does not impact essential performance, basic safety, or substantial equivalence.
Max Current/Power Density	Lower or compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and IEC 60601-2-10. Max Power density < 0.25 W/cm² to reduce thermal burns.	Max Current Density (500Ω): 0.22 mA/cm² (Predicate: 12.5 mA/cm²). Max Power Density (500Ω): 0.63 mW/cm² (Predicate: 7.9 mW/cm²). Lower, and compliant with FDA guidance (0.22 < 0.25 W/cm²).	Does not impact essential performance, basic safety, or substantial equivalence.
On/Off Time	Compliance with FDA Guidance Document for Powered Muscle Stimulator 510(k)s.	On Time: 1-10 s (Predicate: 1-20 s). Off Time: 1-60 s (Predicate: 1-50 s).	Will not raise any safety or effectiveness issue.
EMG Specifications (Applicable to PMS, FES, Incontinence, Biofeedback)
EMG Sensitivity/Sample Rate/Range	Improved performance over predicate, without impacting SE.	Sensitivity: 0.5 µV (Predicate: 1 µV). Sample Rate: Up to 4 kHz (Predicate: 3 kHz). Range: ± 6000 µV (Predicate: 1-2000 µV).	Considered an improvement; does not impact SE.
EMG Bandwidth/Signal Processing	Not impacting essential performance, basic safety or substantial equivalence due to different filtering methods/algorithms (both standard).	Bandwidth: 0 - 2 kHz pre-filtering/20 - 100 Hz post (Predicate: 70-480 Hz). Signal Processing: RMS (New) vs. AVR (Predicate).	Does not impact essential performance, basic safety, or substantial equivalence.
Synchronous/Alternating Triggering	Synchronous acquisition is an improvement over alternating; not impacting SE.	Synchronous (Predicate: Alternating). Allows sample-to-sample comparison.	Considered an improvement; does not impact SE.
Incontinence Programs
Pulse Width/Frequency	Within range of standard EMS pulse modulation and compliant with FDA Guidance and IEC 60601-2-10.	Pulse Width: 150-250 µs (Predicate: 300-500 µs). Frequency: 0-50 Hz (Predicate: 5-60 Hz).	Does not raise new safety or effectiveness questions.
Max Phase Charge/Current Density/Power Density	Compliant with FDA Guidance and IEC 60601-2-10. Max Power density < 0.25 W/cm² to reduce thermal burns.	Max Phase Charge: 25 µC (Predicate: 50 µC). Max Current Density (500Ω): 0.65 mA/cm² (Predicate: 4.7 mA/cm²). Max Power Density (500Ω): 0.40 mW/cm² (Predicate: 0.42-105 mW/cm²). Lower, and compliant with FDA guidance (<0.25W/cm²).	Does not raise new safety or effectiveness questions.
Biofeedback
Time Range	Compliance with IEC 60601-1 and IEC 60601-2-10.	5-20 min (Default 10 min) (Predicate: 5-30 min).	Does not impact essential performance, basic safety, or substantial equivalence.

2. Sample Size and Data Provenance:

This document is a 510(k) summary for a physical medical device (neuromuscular stimulator) and associated software, not a diagnostic AI/ML model that would typically involve a "test set" of clinical data to establish diagnostic performance. Therefore, the concepts of "sample size used for the test set" and "data provenance" (country, retrospective/prospective) in the context of clinical performance are not directly applicable in the way they would be for an AI/ML diagnostic.

The "testing" mentioned in this document refers to:

Bench Testing / Electrical Safety / EMC Testing: These are engineering and performance verification tests performed in a lab setting to ensure the device meets specified electrical, safety, and electromagnetic compatibility standards (e.g., IEC 60601 series). No specific "sample size" is mentioned for these tests, as they are typically conducted on a limited number of devices to demonstrate design compliance.
Software Verification and Validation (V&V): This ensures the software functions as intended and mitigates risks. Again, this is a technical V&V process, not a clinical data-driven "test set."
Usability Testing: This assesses the user interface and safety of use.
Biocompatibility Testing: For materials in contact with the body.

The document does not describe a clinical study with patients or a "test set" of clinical data adjudicated by experts to prove diagnostic accuracy or clinical effectiveness for the device's indications for use. The substantial equivalence is argued based on technological characteristics and compliance with recognized standards, assuming that the predicate device's clinical performance and safety profile are well-established.

3. Number of Experts used for Ground Truth and Qualifications:

Not applicable, as this is solely based on substantial equivalence to a predicate device and compliance with engineering standards, rather than a clinical study requiring expert adjudication of ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies involving human readers or the measurement of human reader improvement with or without AI assistance. This device is not an AI diagnostic tool in the typical sense that would necessitate such a study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No standalone clinical performance study was done. The document focuses on the technical performance of the device's stimulation and biofeedback functions, its safety, and its electromagnetic compatibility through bench testing and compliance with recognized standards. This is not a software-only diagnostic AI that would generally have a "standalone performance" measurement against clinical ground truth.

7. The Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" is that the predicate device (Stiwell med4) is already legally marketed and presumed safe and effective for its intended uses. The "proof" is the demonstration through engineering tests and comparison of technical specifications that the new device (Stella BIO) is "substantially equivalent" to this established predicate, meaning its differences do not raise new questions of safety or effectiveness. There is no clinical "ground truth" derived from patient outcomes or expert consensus on a test set mentioned.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that undergoes "training" on a dataset. The software within the device is validated against its functional requirements and safety specifications, rather than being "trained" on data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI/ML model for this device.

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