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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.

2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for substantial equivalence, not a clinical study on a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this type of submission.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For the technical specifications, the "ground truth" is the established electrical and physical properties of the device as measured and tested against recognized standards and the specifications of predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In essence, the "study" proving the device meets acceptance criteria (as determined by the FDA for TENS devices in a 510(k) context) is the technical comparison presented in the predicate comparison table and the declaration of conformity to established safety and performance standards. It demonstrates that the WiTouch™ Pro is as safe and effective as previously cleared TENS devices already on the market, based on its electrical characteristics and design.

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