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To be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.

The second-generation WiTouch Pro (a.k.a. WiTouch/Neubac) device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The device accessories are the replaceable Gel Pads, the Mobile App, and the optional wireless handheld remote control. The Gel Pads serve to gently adhere the TENS unit to a user's skin on the lower back, and serves to dissipate electrical stimulation across the surface area of the electrode. The Gel Pads are intended for single person use with the number of uses dependent upon skin type, oils, and pH levels.

The TENS unit adheres to the user's lower back across the spine in the area where pain is perceived. Once placed, a user can choose from four 30-minute preprogrammed stimulation output modes, and the level of intensity that is most comfortable. The preprogrammed modes are identified as WiTouch Pro Exclusive, High Frequency, Low Frequency, and High-Low Combo.

Accessories:

• Pairs of replaceable hydrogel pads (Gel Pads) ●
• Mobile Medical Application control using a smartphone via Bluetooth® ● connection (Apple® iOS® or Android® platforms)
• Handheld wireless Remote Control.

Here's an analysis of the provided text regarding the acceptance criteria and study for the WiTouch Pro, WiTouch, Neubac device:

It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For such devices, acceptance criteria and studies typically focus on electrical safety, electromagnetic compatibility, biocompatibility, and functional performance, rather than clinical efficacy studies in the same way an AI-powered diagnostic device would require.

The document does not describe an AI/ML-powered device. It's a TENS device, and the "study" mentioned is conformity to recognized standards and non-clinical performance testing against a predicate device. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable here.

Acceptance Criteria and Device Performance (Not Applicable for AI/ML performance, but for device characteristics and safety standards)

• Number of Output Channels: 1
• Regulated Current or Regulated Voltage?: Voltage
• Waveform: Asymmetrical biphasic (0 net DC charge)
• Amplitude: 0 – 80mA (Measured @ 500 ohm load)
• Pulse Width: 120 - 250μs (Preprogrammed)
• Pulse Rate: 2 - 120 Hz |
  | Safety Features | - Low battery indicator: Yes
• Automatic Shut Off?: Yes
• User Override Control?: Yes (Off button immediately stops treatment) |
  | Physical and Operational Characteristics | - Power Source(s): (2) "AAA" Alkaline Batteries (TENS Unit), (1) "CR 2032" Lithium-ion coin battery (Remote Control)
• Software/Firmware/Microprocessor Control?: Yes
• Indicator Display: On/Off Status (Yes), Low Battery (Yes), Voltage/Current Level (No)
• Timer Range: Nonadjustable (30 minutes)
• Weight: 4.8 oz. w/ batteries included
• Dimensions: 7.5 (w) x 3.5 (h) x 0.7 in (d) |
  | Compliance with Recognized Standards | • FDA Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06
  • FDA Recognition Number 19-4: ANSI/AAMI ES60601-1:2005 Ed. 3 + C1:2009 + A1:2012
  • FDA Recognition Number 19-16/19-7: ANSI/AAMI HA60601-1-11:2015/2011
  • FDA Recognition 19-8. IEC 60601-1-2:2014 Ed. 4
  • FDA Recognition Number 19-14: IEC 60601-1-11 Edition 2.0 2015-01
  • FDA Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06
  • FDA Recognition Number 5-40: ISO 14971 Second edition 2007-03-01 |

Detailed Analysis for AI-Specific Questions (Not Applicable as per the document):

Given that this is a 510(k) for a TENS device and not an AI/ML-powered device, the following points are largely not applicable based on the provided text. The "study" here refers to non-clinical testing and conformity to engineering and safety standards, demonstrating substantial equivalence to a predicate device.

1. Sample size used for the test set and the data provenance:

   • Not Applicable. The document describes non-clinical testing for substantial equivalence to a predicate TENS device, not a diagnostic AI test. No "test set" in the context of an AI algorithm's performance is mentioned. The device's performance characteristics (e.g., amplitude, pulse width, pulse rate) are tested against engineering specifications and compared to the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is not an AI diagnostic device requiring expert-established ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. No ground truth adjudication process for AI performance is described.

4. 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:

   • Not Applicable. This device is a direct-to-patient TENS unit, not an AI assistance tool for human readers/clinicians, so no MRMC study or AI assistance effect size is relevant or described.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. The device is a standalone TENS unit, but not a standalone AI algorithm. Its performance is evaluated through non-clinical metrics (e.g., electrical output, adherence to safety standards).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. For this TENS device, "ground truth" would relate to its physical and electrical properties meeting specifications and safety standards, rather than a clinical diagnostic truth. The "truth" is whether it functions as designed and is safe.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set or ground truth establishment for AI is mentioned.

Summary of the Device Evaluation per the Document:

The evaluation for the WiTouch Pro, WiTouch, Neubac device focused on demonstrating substantial equivalence to its predicate device (the first-generation WiTouch Pro K120398). This was achieved through:

• Non-Clinical Testing: Verification, validation, and performance data of the second-generation device.
• Conformity with Recognized Standards: Various IEC and ANSI/AAMI standards related to electrical safety, medical device software, and biocompatibility (though biocompatibility testing itself is not detailed, it's typically covered by standards compliance).
• Comparison of Characteristics: A detailed table comparing the subject device's features (e.g., indications for use, power source, output parameters, safety features) to those of the predicate device. The document explicitly states, "The differences between the predicate device and the subject device do not raise new questions about safety or effectiveness."

The document concludes that "Clinical testing was not required to support substantial equivalence for the second-generation WiTouch Pro TENS device" because the intended use is well-established, and hardware/software verification demonstrates comparable performance to the predicate.

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Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fracture
• Joint pain
• Discogenic pain

The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.

The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.

Painted sheet metal and ABS plastic encasement housing electronic circuitry; software and electronics engage a gear driven motor with load sensors; slide mechanism, and patient head harness to apply cervical traction.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) premarket notification letter from the FDA to Hollywog, LLC, regarding their device called "Modpod".

This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (K051938 and K053223). It details:

• Indications for Use: The medical conditions the device is intended to treat.
• Technical Specifications: Information about the device's design, power supply, components, and operational characteristics.
• Comparison to Predicate Devices: A comprehensive table comparing the Modpod to the predicate devices across various parameters like regulation, product class, intended use, anatomical site, maximum traction force, electrical standards, etc.

However, the document does not contain information about specific acceptance criteria (performance metrics) or a study report with associated data and statistical analysis that proves the device meets such criteria. It states that "The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices," which is a conclusion based on the comparison provided, but not a detailed study report with results against predefined acceptance criteria.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

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The device is for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the user's lower back.

The device is a battery powered over the counter transcutaneous electrical nerve stimulator with a wireless remote control feature. The general purpose of the device is to apply an electrical stimulus to integral electrodes that are applied to a user's lower back to relieve pain. The device includes a current generator and permanently-affixed electrodes with user replaceable single patient use hydrogel pads (gel-pads) that may be reused for a limited number of reuses. The number of reuses of the gel-pads varv person-to-person dependent upon skin type, oils and pH levels. One side of the adhesive gel-pad adheres to the electrode, and the other the device to the healthy intact skin of the user's lower back to provide an analgesic electrical stimulus to the painful area. The user controls are located on a hand-held wireless remote control commonly referred to as a Key-fob. The user controls are simple straightforward power on/off and electrical stimulus intensity up/down.

This document describes a 510(k) premarket notification for "The Pain Pilot™ (a.k.a. Pain Pilot™) / WiTouch™," a transcutaneous electrical nerve stimulator (TENS) device. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its efficacy through extensive clinical studies and acceptance criteria as might be seen for novel devices.

Therefore, the information provided focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety standards, rather than presenting a performance study with acceptance criteria in the typical sense for algorithm performance.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as performance metrics for an algorithm or device efficacy study. Instead, it demonstrates compliance with recognized safety standards and substantial equivalence to predicate devices based on technical specifications. The "performance" is implicitly tied to meeting these standards and being comparable to legally marketed TENS devices.

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

This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to existing predicate devices through technical comparisons and adherence to recognized standards. It does not present a clinical study with a "test set" and "data provenance" in the context of evaluating algorithm performance or clinical efficacy against specific acceptance criteria. The "study" here is predominantly a technical and regulatory comparison.

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

Not applicable. As noted above, there's no clinical "test set" with ground truth established by experts for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

Not applicable. This device is a TENS unit, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

Not applicable. There is no "ground truth" as would be established for an AI algorithm or diagnostic test. The device's "truth" is its compliance with safety standards and its substantial equivalence to other legally marketed TENS devices.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. No training set is involved.

Summary of the "Study" that Proves the Device Meets the Criteria:

The "study" presented in this 510(k) submission is a demonstration of substantial equivalence to legally marketed predicate devices, along with evidence of compliance with relevant FDA-recognized safety and performance standards.

• Methodology: The submission extensively compares the new device (The Pain Pilot™ / WiTouch™) to three predicate TENS devices (PM3030™, Painmaster™ MCT Patch, and T1040™). This comparison covers:
  • Indications for Use (showing equivalence for lower back pain relief).
  • Intended Use (showing equivalence in providing analgesic electrical stimulus).
  • Technical specifications (e.g., power source, output modes/channels, control mechanisms, timer, dimensions, electrical characteristics like current density and power density).
  • The submission argues that differences (like integral electrodes and wireless remote control) are "insignificant as it relates to safety and effectiveness, and is not critical to the intended use."
• Evidence: The primary evidence provided is the detailed table comparing the various specifications of the new device against the predicate devices (page 3 of 4). Additionally, declarations of conformity to numerous FDA-recognized international and national standards (IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) are provided (page 4 of 4).
• Conclusion: The FDA's letter (pages 5-6 of 6) states that they have "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the regulatory "acceptance criteria" for marketing under the 510(k) pathway.

In essence, for a 510(k) submission like this for a TENS device, the acceptance criteria are satisfied by proving the new device is as safe and effective as a device already on the market through detailed technical comparison and adherence to recognized standards, rather than through a clinical trial with performance metrics.

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The WiTouch" Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.

The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.

The provided 510(k) summary for the WiTouch™ Pro Transcutaneous Electrical Nerve Stimulator (TENS) device does not contain information about acceptance criteria or a dedicated study to prove that the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than performance metrics related to diagnostic accuracy or clinical outcomes of a new treatment modality.

Here's a breakdown of why many of your requested items cannot be fulfilled from this document:

• Acceptance Criteria & Reported Performance: This document doesn't define quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score) for the device's efficacy in pain relief. Instead, it compares technical specifications (waveform, current density, power density, physical characteristics) to predicate devices to argue substantial equivalence.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type for Test Set: These are all concepts relevant to studies evaluating the diagnostic or therapeutic performance of a device or algorithm, often involving patient data and human expert review. This 510(k) does not describe such a study. The "study" here is essentially the comparison of technical specifications against FDA-recognized safety and electrical standards and existing predicate devices.
• Training Set Sample Size & Ground Truth: These are concepts for AI/ML model development. The WiTouch™ Pro is a hardware TENS device, not an AI/ML diagnostic tool, so these concepts do not apply in this context.

Summary of Information Available from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, it demonstrates inherent safety and equivalence through compliance with recognized standards and comparison of technical specifications to legally marketed predicate devices. The "reported device performance" is essentially that its electrical output and physical characteristics are within acceptable ranges and comparable to existing TENS devices.

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