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The X-Force external, non-invasive, non-narcotic, clectrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product can be used in the home or clinic by all patients in need.

The X-FORCE device is a microcomputer controlled digital device featuring a NT Mode output. The device provides simple programming facility to customize the treatment. The panel and its keys provide easy selection for treatment. It is device that deploys the use of electrotherapy and compression to treat Osteoarthritis (OA) and rheumatoid arthritis of the knee or hand.

The X-Force consists of electrodes, the lead wires, and the signal generator. The device is portable and rechargeable battery operated. The lead wires connect the electrodes to the device. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "X-Force" and compares it to a predicate device, "J-Stim 1000".

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" through a table or specific quantitative thresholds for performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the J-Stim 1000. The key "acceptance criterion" here is that the new device, X-Force, is "as safe, as effective and performs as well as its predicate device."

The "reported device performance" is essentially that the X-Force operates under the same principles and delivers similar electrical parameters as the J-Stim 1000. The comparison focuses on technological characteristics and basic unit characteristics, where "similarity" or "sameness" acts as the performance metric.

• Device Housing: Similar (ABS material, different sizes/weights).
• Channels: Same (Two Channels).
• Modes: Same (One).
• Display: Similar (Customized LCD).
• Waveform: Same (NT (HiVolt) - Pulsed Monophasic).
• Treatment Timer: Same (YES).
• Target Populace: Same. |
  | Basic Unit Characteristics Equivalence | - Power Source: Different (Rechargeable 4x1.2V vs. 9V Li-ion).
• Line Current Isolation: Same (battery operated, isolated from mains).
• Patient Leakage Current: Same (less than 100μA normal, less than 300µA single fault, Referenced IEC 60601-1).
• Output Modes/Channels: Same (Synchronous, 1 mode, 2 channels).
• Regulated Output: Same (Regulated Voltage).
• Max Output Current/Voltage/Phase Charge/Current Density/Power Density: All reported as identical.
• Software/Firmware/Microprocessors: Same (YES).
• Automatic Trips/Shut-off/Patient Override: All same (YES).
• Indicator Display: Same (YES for On/Off, Low Battery, Voltage/Current).
• Timer: Same (YES).
• Compliance with 21 CFR 898: Same (YES).
• Program Lock Feature: X-Force has this, J-Stim 1000 does not. This is deemed not to affect safety or effectiveness.
• Digital Control of Output Power: X-Force uses digital control via microcontroller, J-Stim 1000 uses analog pots. This difference is presented without explicit safety/effectiveness impact beyond it being a technological variation. |
  | Safety and Effectiveness (Overall Equivalence Conclusion) | X-Force is concluded to be as safe, as effective, and performs as well as the predicate device, J-Stim 1000. |

2. Sample Size Used for the Test Set and the Data Provenance

The submission explicitly states:

• "Non-Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"
• "Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"

This means there was no specific test set or clinical study conducted for the X-Force device to prove its performance in an independent test, nor is there data provenance like country of origin or retrospective/prospective status for such a test set. The submission relies entirely on the established safety and effectiveness of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no specific test set or clinical study was conducted for the X-Force device, there were no experts used to establish ground truth for a test set in this submission. The ground truth for the device's equivalence is based on engineering and performance specifications comparison to the predicate device.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method applied.

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 device (TENS stimulator) is not an AI-powered diagnostic device, and the submission does not involve any "human readers" or "AI assistance" in the context of interpreting medical images or data. Therefore, no MRMC comparative effectiveness study was done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-only device. It is a physical medical device. There's no standalone algorithm performance study as it's not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this submission is the established safety and effectiveness of the predicate device (J-Stim 1000), as previously determined by the FDA's approval (K073386). The new device (X-Force) claims equivalence through comparative analysis of its specifications and intended use against this established ground truth.

8. The Sample Size for the Training Set

Since no new clinical or non-clinical testing was performed for the X-Force for this submission, there was no specific training set in the context of device performance studies. The "training" in an abstract sense comes from the design and manufacturing experience informed by devices like the predicate.

9. How the Ground Truth for the Training Set Was Established

Given that no specific training set was used for this submission, the question of how its ground truth was established is not applicable. The submission leverages the pre-existing FDA approval of the predicate device as its basis for demonstrating safety and effectiveness.

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