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510(k) Data Aggregation
(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.
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(153 days)
PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078)
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.
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