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510(k) Data Aggregation
(428 days)
KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)
TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.
KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Low-frequency Multi-function physiotherapy instrument. This document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technical specifications and an assessment of safety and performance testing against recognized standards. It does not detail a study involving specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for an AI/CADe device, as the device itself is a physiotherapy instrument, not a diagnostic imaging AI.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment for training, etc.) are not applicable in this context.
However, I can extract the closest equivalents to acceptance criteria and reported "performance" based on the provided safety and performance tests.
Here's a breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
For a physiotherapy instrument, "acceptance criteria" relate to meeting safety and performance standards. The "reported device performance" is that the device complies with these standards.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 | Complies with standards |
| Electromagnetic Compatibility: IEC 60601-1-2 | Complies with standard |
| Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 | Complies with standards (for all user-contacting materials) |
| Usability: IEC 62366-1 | Complies with standard |
| Software Verification & Validation: FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices | Complies with FDA guidance |
| Waveform Test (Output Specifications): Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning | Complies with guidance; verifies output specifications |
| Patient Leakage Current: (e.g., < 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Average DC current through electrodes (no pulses): (< 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Maximum Output Voltage (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 55V±10%@ 500 Ω; 75V±10% @ 2K Ω; 85V±10% @ 10K Ω |
| Maximum Output Current (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 110mA±10% @ 500 Ω; 37.5mA±10% @ 2K Ω; 8.5mA±10% @ 10K Ω |
| Pulse Duration (TENS, EMS, FITNESS) | TENS: 120µs, EMS: 200µs, FITNESS: 200µs |
| Pulse frequency (TENS, EMS, FITNESS) | TENS:(20-100)Hz, EMS:(1-15)Hz, FITNESS:(2-16)Hz |
| Net Charge (per pulse) @ 500 Ω | 0µC (Balanced waveform) |
| Maximum Phase Charge @ 500 Ω | 15.97 µC |
| Maximum Average Current | 1.60mA |
| Maximum Current Density (r.m.s) @ 500 Ω | 0.064mA/cm² |
| Maximum Average Power Density | 0.08mW/cm² |
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 provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical trial with a "test set" of patients or data in the typical sense of AI/CADe validation.
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/provided. The device is a physiotherapy instrument, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication is typically for expert review of cases in diagnostic studies, which is not relevant here.
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/provided. The device is a therapeutic physiotherapy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is not an algorithm for standalone performance assessment in the context of diagnostic AI. The "performance" assessment is about meeting electrical, EMC, biocompatibility, and output specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's acceptable performance is defined by compliance with established international and FDA-specific standards and guidances for electrical safety, electromagnetic compatibility, biocompatibility, usability, software, and waveform output specifications. This effectively serves as the "ground truth" for its safety and effectiveness for its intended use.
8. The sample size for the training set
This information is not applicable/provided. The document does not describe a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided. (See point 8)
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