(189 days)
The Infinity Plus is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES) and interferential current stimulation (IFS).
As a NMES device, the Infinity Plus device is indicated for the following conditions:
- Retarding or preventing disuse atrophy .
- Maintaining or increasing range of motion .
- Re-educating muscles .
- Relaxation of muscle spasm .
- Increasing local blood circulation .
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As an IFS device, the Infinity Plus is indicated for the following conditions:
- Symptomatic relief of acute pain .
- Symptomatic relief and management of chronic intractable pain .
- As an adjunctive treatment for post surgical and post traumatic acute pain .
The Empi Infinity Plus Electrotherapy System is a battery-powered/line-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The Infinity Plus offers the following features:
- Channel 1 to 4, which are multi-purpose outputs (IF and NMES) .
- High Voltage output dedicated to the High Volt stimulation. (This is named CH5 in the Software Requirements Specification and Software Design Specification. It is a separate channel that is simply the output for the high voltage stimulation).
- Channel 1, 2, 3 and 4 support stimulation with:
- IF: 2 independent IF channels using the channel pairs: Channel 1/2 and Channel 3/4
- PM, NMES, Russian: 4 independent PM channels
- Serial contractions: 4 dependent channels forming the movement pattern
- HV out is dedicated to High Volt stimulation
- All channel outputs are electrically separated from each other
- Each channel has a dedicated intensity control, with the exception of the HV out. The intensity control of HV is achieved by using the Channel 1 intensity control.
- Maximum stimulation of 100 mA for IF, PM, NMES, and Russian; 500 V for High Volt
- Timed therapy sessions .
- Continuous or cycled stimulation .
- Adjustable pulse rates
- Adjustable ON and OFF time controls .
- Balanced symmetrical biphasic and monophasic high volt waveforms .
- Forty-three programs: three conventional interferential, three premodulated interferential, seven High Volt, thirteen NMES, thirteen Russian and four Serial Contraction
- Lock option for clinician to control treatment regimens and stimulus intensity
- Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters with stimulus intensity of zero
The provided text describes a 510(k) summary for the Infinity Plus Electrotherapy System. It details the device's intended use, description, and basis for substantial equivalence to predicate devices. However, the document does not contain information regarding
acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a clinical study report or a more detailed submission for proving device performance.
Therefore, I cannot provide a complete answer to your request. The information below is limited to what is explicitly stated or can be inferred from the provided 510(k) summary.
Here's what can be extracted based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state any quantitative acceptance criteria or provide specific reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for clinical outcomes. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and function.
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Not Explicitly Stated for Performance) |
|---|---|
| Implied: Device performs similar to predicate devices for stated indications. | Implied: Device provides NMES and IFS stimulation as intended. |
| Implied: Device delivers specified electrical parameters (e.g., maximum stimulation current/voltage, adjustable pulse rates/on/off times). | Implied: Device can deliver 100 mA for IF, PM, NMES, Russian, and 500 V for High Volt. |
| Implied: Device offers the stated features (e.g., 4 channels, specific waveforms, timed therapy, continuous/cycled stimulation, lock option). | Implied: Device possesses the listed features. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not describe any specific clinical "test set" or clinical study with a defined sample size to prove performance. The submission relies on a comparison to predicate devices. Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available for such a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific clinical "test set" is described for proving performance, there is no information provided on experts establishing ground truth. This type of information would typically be found in a clinical trial report.
4. Adjudication Method for the Test Set
As no specific clinical "test set" is described, there is no information provided on adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on device features and equivalence rather than comparative clinical outcomes with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Infinity Plus Electrotherapy System is a physical medical device for delivering electrical stimulation, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. Its performance is inherent in its ability to generate and deliver the intended electrical waveforms, which is typically confirmed through engineering verification and validation, not standalone clinical studies in the AI sense.
7. The Type of Ground Truth Used
Given that no specific studies are detailed to prove performance in the clinical sense, there is no mention of a type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" in this context for a 510(k) relating to a physical electrotherapy device would be the device's ability to produce the specified electrical output parameters accurately and safely, as measured by engineering tests.
8. The Sample Size for the Training Set
The provided document does not discuss any "training set." This term is typically associated with machine learning or artificial intelligence models, which the Infinity Plus Electrotherapy System is not.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" mentioned, there is no information on how its ground truth was established.
Summary of what the K041920 document DOES provide:
- Basis for Substantial Equivalence: The primary method for clearance for the Infinity Plus Electrotherapy System is demonstrating substantial equivalence to previously cleared predicate devices (Empi 300 PV and Chattanooga Vectra Pro 4 and Pro 2 Models).
- Comparison of Features: The document lists features of the Infinity Plus (e.g., four channels, Russian waveform, specific current/voltage limits) and highlights how these are either present in the predicate Empi 300 PV or in the other predicate devices (Chattanooga Vectra Models).
- Indications for Use: The Infinity Plus shares the same indications for use as the predicate devices for NMES and IFS.
- Regulatory Conclusion: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
This 510(k) summary is a regulatory document focused on demonstrating equivalence for market clearance, rather than a detailed report of a clinical performance study with defined acceptance criteria and results.
§ 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).