(136 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 Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components: Katalyst Suit, Impulse Pack, and Katalyst Training Station. The Katalyst Suit is worn by the client and contains electrodes for major muscle groups. The Impulse Pack is a powered muscle stimulation device that connects to the suit and delivers EMS impulses. The Katalyst Training Station is a computer-based system with a touch screen and rotary encoders used to configure and run training sessions and adjust intensity levels.
This document is a 510(k) Summary for the Katalyst Mark 1 Muscle Stimulation System Model 2. It assesses the substantial equivalence of the new device to existing legally marketed predicate devices. The document does not describe an acceptance criteria table with reported device performance or a study proving that the device meets acceptance criteria in the way a clinical trial or performance study for a new AI/software device would.
Instead, this 510(k) submission focuses on demonstrating substantial equivalence through non-clinical testing, comparing device characteristics and output specifications to predicate devices, and explaining differences.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device (a powered muscle stimulator, not an AI/software as a medical device that makes diagnostic or treatment recommendations).
However, I can extract information relevant to the non-clinical testing performed and how the device's equivalence was established.
Here's a breakdown of what is available and what is N/A based on the provided text:
1. A table of acceptance criteria and the reported device performance
This specific format is not present. The document instead provides tables comparing the characteristics and output specifications of the new device to its predicate devices, aiming to show substantial equivalence. The "acceptance criteria" for a 510(k) submission like this are implicit in meeting regulatory standards and demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing.
Comparison of Device Characteristics (Table 014-2 & 014-3):
| Characteristic | New Device (Katalyst Mark 1) | Primary Predicate (Compex Sport Plus K083140) | Secondary Predicate (E-Fit EF-1280 K133225) | Similar/Different |
|---|---|---|---|---|
| Indications for Use | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. Rx Only. | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. | Stimulate healthy muscles to improve/facilitate muscle performance. Not for therapy/treatment of medical conditions. | K083140 - Similar |
| K133225 - Similar | ||||
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | K083140 - Similar |
| K133225 - Similar | ||||
| Shape | Rectangular | Rectangular | Rectangular | K083140 - Similar |
| Max Output Voltage | 60 V @ 500 Ω, 96 V @ 2 kΩ, 114.2 V @ 10 kΩ | 60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ | 36 V @ 500 Ω | K083140 - Similar (at 500 Ω) |
| K133225 - Different | ||||
| Note: Differences in output specs are addressed in the "Differences" section to show they don't adversely affect safety/effectiveness. | ||||
| Max Output Current | 120 mA @ 500 Ω, 48 mA @ 2 kΩ, 11 mA @ 10 kΩ | 120 mA @ 500 Ω, 82 mA @ 2 kΩ, 16 mA @ 10 kΩ | 72 mA @ 500 Ω | K083140 - Similar (at 500 Ω) |
| K133225 - Different | ||||
| Positive Pulse Width | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - Different |
| K133225 - Similar | ||||
| Frequency | 85Hz | 1 to 120Hz | 5 to 120Hz | K083140 - Similar (within range) |
| K133225 - Different | ||||
| Net Charge | $0.5 [\mu C] @ 500\Omega$ (fully compensated) | $0 [\mu C] @ 500\Omega$ (fully compensated) | $0 [\mu C] @ 500\Omega$ (fully compensated) | K083140 - Similar |
| K133225 - Similar | ||||
| Max Phase Charge | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - Similar |
| K133225 - Similar | ||||
| Max Current Density | $0.788mA/cm^2 @500\Omega$ | $1.49mA/cm2 @ 500\Omega$ | $0.85mA/cm2 @ 500\Omega$ | K083140 - Different |
| K133225 - Similar | ||||
| Max Power Density | $8.16mW/cm^2 @ 500 \Omega$ | $27.6mW/cm2 @500\Omega$ | $6.3mW/cm2 @ 500 \Omega$ | K083140 - Different |
| K133225 - Similar |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This refers to the number of devices tested (bench testing), not a sample size of patients or images as would be the case for AI/SaMD. The document describes several non-clinical tests (Biocompatibility, Software Verification and Validation, Electrical Safety and EMC, Battery Testing, Engineering Bench Testing). For these types of tests, the sample size typically refers to a small number of manufactured units or components. The specific number of units tested is not specified in this summary.
- Data Provenance: Not applicable in the context of patient data. The tests are bench and laboratory tests on the device hardware and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The ground truth for a muscle stimulator is established by engineering specifications, international safety standards (e.g., IEC 60601 series), and direct measurement of electrical output, not by expert medical review of patient data.
4. Adjudication method for the test set
- This is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes for establishing ground truth in image interpretation or clinical outcomes, which is not relevant for this device's testing.
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 is not applicable. This device is a muscle stimulator, not an AI for image interpretation or diagnosis. There are no "human readers" or AI assistance involved in its direct function for which an MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This device is a physical product designed for human interaction (an operator applies and controls it), not a standalone algorithm. Its software validation ensures it performs as designed, but not in a "standalone algorithm" performance sense for diagnostic accuracy.
7. The type of ground truth used
- The "ground truth" for this device's safety and performance is established through adherence to recognized electrical safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133), software verification against requirements, and engineering bench testing (oscilloscope tracings, load testing). The goal is to ensure the device outputs signals within safe and intended parameters and performs reliably.
8. The sample size for the training set
- This is not applicable. This device is not an AI/ML model that learns from large training datasets. Its software is programmed based on engineering design, not trained.
9. How the ground truth for the training set was established
- This is not applicable for the same reasons as #8. The "ground truth" for software functionality is the design specification and functional requirements, which are then verified and validated.
§ 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).