(153 days)
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components:
Katalyst Suit: Worn by the client, the Katalyst Suit is a compression textile with embedded electrodes connected by a cable harness. When connected to the Impulse Pack it provides localized EMS impulses to major muscle groups at controllable intensities.
Impulse Pack: A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers electrical impulses through a battery powered regulated booster. The Impulse Pack is operator controlled wirelessly via the Katalyst Application over Bluetooth.
Katalyst Application: Controlled by the Operator, the Katalyst Application is run on a Microsoft Surface Pro 3 running Windows 10 Professional. It is used to configure and run a Katalyst training, including the setting of independent intensities for each muscle group channel.
Accessories included: cable harnesses and an Impulse Pack charging cable.
The provided document is a 510(k) Summary for the Katalyst Mark 1 Muscle Stimulation System. It details the device, its indications for use, comparison with predicate devices, and non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or effect size for AI assistance.
Instead, the document outlines various non-clinical tests conducted to demonstrate that the device is substantially equivalent to existing predicate devices in terms of safety and effectiveness, based on recognized standards and guidance. The 'acceptance criteria' in this context refer to compliance with these standards and established performance parameters of the predicate devices, rather than a specific performance target for diagnostic or assistive accuracy.
Therefore, many of the requested sections of your prompt, particularly those related to a clinical study demonstrating AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, cannot be extracted from this document as such information is not present. The Katalyst Mark 1 is a physical muscle stimulation system, not an AI-powered diagnostic or assistive tool in the way your prompt defines.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a powered muscle stimulator, the "acceptance criteria" are primarily based on compliance with electrical safety, EMC, and biocompatibility standards, as well as a comparison of its technical specifications (e.g., waveform, output voltage, current, pulse width, frequency) to predicate devices to establish substantial equivalence.
| Acceptance Criteria (Compliance/Comparison) | Reported Device Performance (Katalyst Mark 1) |
|---|---|
| Biocompatibility (ISO 10993-10:2009, ISO 10993-5:2009) | Tested to standards under GLP. |
| Software Verification & Validation (Moderate level of concern) | All software requirement specifications met, all software hazards mitigated to Accepted risk level. |
| Electrical Safety (IEC/EN 60601-1:2005 Ed 3.1) | Complies and tested. |
| Muscle Stimulator Specific Safety (IEC 60601-2-10:2012 Ed 2.0) | Complies and tested. Specifically, concerning current density >2mA/cm², additional warnings and guidance included in Operator's Guide, and tested to standard. |
| Electromagnetic Compatibility (EMC) (IEC/EN 60601-1-2:2014 Ed 4.0) | Complies and tested. |
| Battery Safety (IEC 62133 Ed 2.0, for Li-Po) | Tested by battery manufacturer for compliance. |
| Wireless Risks Mitigation (FDA Guidance: "Radio Frequency Wireless Technology in Medical Devices") | System validation testing scenarios covering mitigation of wireless risks were added to full system testing protocol to ensure safe and effective use. |
| Output Waveform | Symmetrical Biphasic, Rectangular. |
| Maximum Output Voltage | 60 V @ 500 Ω, 96 V @ 2 kΩ, 114.2 V @ 10 kΩ. |
| Maximum Output Current | 120 mA @ 500 Ω, 48 mA @ 2 kΩ, 11 mA @ 10 kΩ. |
| Positive Pulse Width | 75µs or 175µs. |
| Negative Pulse Width | 75µs or 175µs. |
| Frequency | 85Hz or 100Hz. |
| Net Charge [µC/pulse] | 0.5 [µC] @ 500Ω, Excitation pulse fully compensated. |
| Maximum Phase Charge [µC] | 21µC @ 500 Ω. |
| Maximum Current (RMS) Density [mA/cm2] | 2.4mA/cm² @ 500Ω. |
| Maximum Power Density [mW/cm2] | 5.04mW/cm² @ 500 Ω. |
| Adherence to FDA Guidance Document for Powered Muscle Stimulator 510(k)s (1999) | Testing conducted in accordance with recommendations. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is non-clinical (bench testing, software validation, component testing) rather than a study on a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided as this is not a diagnostic device involving expert ground truth for image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. The device is a muscle stimulator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The "system validation testing" for software ensures that the device's software functions as intended to control the electrical stimulation, but it's not an AI algorithm performing a diagnostic or interpretive task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Biocompatibility: Ground truth is established by the pass/fail criteria of the ISO 10993 standards.
- Software Verification and Validation: Ground truth is established by the software requirement specifications and hazard analysis.
- Electrical Safety, EMC, Battery Testing: Ground truth is established by the pass/fail criteria of the respective IEC/EN standards.
- Engineering Bench Testing: Ground truth is established by comparing measured output waveforms, voltages, currents, etc., against the specified design parameters and potentially against predicate device performance characteristics (though not explicitly stated as direct comparison on every parameter, rather overall substantial equivalence).
8. The sample size for the training set
This information is not applicable and not provided. The term "training set" is usually relevant for machine learning models, which is not the primary focus of this submission. The software validation is for deterministic software.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
§ 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).