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Light therapy to provide topical heating for:

Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

The Dynatron Tri-wave™ light pad and Dynatron Tri-wave™ light probe generate therapeutic topical heating treatments through the medium of multi-wavelength light energy to targeted tissue.

The Dynatron Tri-wave™ light pad is a bifurcated pad with two 5" x 7" treatment pads connected by a 24" cable between them and a 72" cable connecting to the Dynatron Solaris plus™ controlling console. The two pads accommodate treating both sides of a shoulder, elbow, knee, etc. or may be used side by side to treat larger areas such as the lower back.

The Dynatron Tri-wave™ light probe is designed with super luminous diodes emitting three different wavelengths of light. The Infrared LEDs have a wavelength of 850nm, the Red LEDs have a wavelength of 624nm and the Blue LEDs have a wavelength of 464nm. The light probe handle has an ergonomic design and is suited for treating small areas such as the hand, wrist or neck.

The provided text from K113250 describes a 510(k) premarket notification for the Dynatron Tri-wave™ light pad and probe. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria in a clinical study for a new device.

Therefore, many of the typical questions regarding acceptance criteria, study design, sample sizes, expert ground truth, and MRMC studies are not applicable in the context of this 510(k) submission.

Here's an breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the new device performs similarly and is as safe and effective as the already-cleared devices. No specific "acceptance criteria" in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device) are mentioned for the Dynatron Tri-wave™ light pad and probe. Its performance is implicitly accepted if it performs similarly to the predicate devices.

2. Sample sized used for the test set and the data provenance

Not applicable. This submission does not describe a new clinical performance study with a test set of data. It relies on the established safety and effectiveness of its predicate devices.

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

Not applicable. There is no described test set requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. There is no described test set requiring adjudication.

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 device is a light therapy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.

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

Not applicable. This device is a hardware device for light therapy, not an algorithm.

7. The type of ground truth used

Not applicable. As there is no de novo performance study, there is no ground truth established for the new device's performance against specific criteria. The ground truth, in a broader sense for this type of submission, is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This device is a hardware device; machine learning training sets are not relevant here.

9. How the ground truth for the training set was established

Not applicable. As per point 8, there is no training set for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) Submission):

The "study" in this context is the substantiation of substantial equivalence to legally marketed predicate devices, as documented in the 510(k) submission.

• Mechanism of Proof: The submission aims to prove that the Dynatron Tri-wave™ light pad and probe are substantially equivalent to the Dynatron Xp Infrared Pad (K051261) and D880 Infrared Probe (K031329), respectively.
• Basis for Equivalence:
  • Intended Use/Indications For Use: The indications for use for the Dynatron Tri-wave™ devices are stated to be "consistent with the cleared indications for the predicate devices" (temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, minor pain and stiffness associated with arthritis).
  • Technological Characteristics: The new devices generate therapeutic topical heating through multi-wavelength light energy (Infrared, Red, Blue LEDs). While the predicate devices operate with one primary wavelength, the submission likely argues that the addition of wavelengths does not raise new questions of safety or effectiveness, or that the overall effect is still comparable. The controls and power mechanisms are stated to be the same as the predicate devices.
  • Safety and Effectiveness: The submission states, "There are no substantive differences between the products defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices." It further mentions that the devices are developed under Dynatronics' Quality Management System, subject to design/change control, and verification/validation to applicable standards. This implies that the accepted safety and effectiveness of the "predicate" device's technology form the basis for accepting the new device's safety and effectiveness.

In essence, the acceptance criteria are largely centered on demonstrating that the new device is as safe and effective as the existing predicate devices, and that any technological differences do not introduce new safety or efficacy challenges. The "study" proving this is the careful comparison of the new device's specifications and intended use against those of the predicate devices.

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The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The Dynatron DX2 also functions as a system console for controlling the function of infrared therapy devices such as the Dynatron D880 (K031329) and the Dynatron D890 (D040729). Indications for use of these infrared therapy devices are to provide topical heating for temporary increase in blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.

Components:

System console, model Dynatron DX2, containing electric motor and control electronics with LCD alpha-numeric display.

Pull-head or Goniometer attaches patient harnesses and applied force. Feedback from the Goniometer displays force applied and angle of force.

Accessories such as traction belts.

Output ports on the back of the DX2 system console accommodate infrared therapy devices such as the Dynatron D880 (K031329) and Dynatron D890 (K040729).

This document is a 510(k) premarket notification for the Dynatron® DX2 Combination Traction Unit and Infrared Therapy device. It aims to demonstrate substantial equivalence to predicate devices rather than proving specific performance beyond pre-established standards. Therefore, the information typically found in a study proving acceptance criteria for novel AI/software devices is not present here.

Based on the provided text, I can infer the acceptance criteria relate to:

• Substantial Equivalence: The primary "acceptance criteria" for a 510(k) device is that it is substantially equivalent to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness.
• Compliance with Applicable Standards: The device must conform to relevant standards, such as those outlined in 21 CFR sections 1010 (Performance Standards for Electronic Products: General).
• Safety and Effectiveness: The device must be safe and effective when used as indicated under a clinician's supervision/therapy program. This is often demonstrated by showing similarity to predicate devices that have already proven safe and effective.
• Quality Management System: The device development and documentation must comply with the Quality System Regulation, 21 CFR Part 820.

The "study" that proves the device meets these acceptance criteria, in the context of this 510(k) submission, is the entire submission itself. However, it is fundamentally a comparative analysis rather than a performance study with quantitative metrics and ground truth establishment in the way one would describe for an AI/software device.

Here's an attempt to structure the information, acknowledging the differences:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of this 510(k) submission. This is not a study with a test set of data points (e.g., medical images, patient records) to be analyzed by the device. The "test set" in this type of submission refers to the comparative analysis against predicate devices.
• Data Provenance: Not applicable. The submission relies on a comparison of device characteristics and intended use to existing cleared devices, not on data derived from a study on patient outcomes or diagnostic performance.

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

• Number of Experts: Not applicable. There is no specific "ground truth" to be established by experts for a test set in this 510(k) submission. The safety and effectiveness are inferred from the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no test set in the traditional sense that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human reader performance is being evaluated. The Dynatron DX2 is a physical therapy device.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone performance study (as understood for AI/software) was not done. The device's function is mechanical traction and controlling infrared therapy devices, not an algorithm performing a diagnostic or interpretive task. Its intended use inherently involves human supervision ("under a clinician's supervision/therapy program").

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. For a 510(k) submission demonstrating substantial equivalence for a physical therapy device, the "ground truth" is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and regulatory history, along with compliance with general performance standards for electronic products.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device does not involve machine learning algorithms that require a "training set."

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

• Ground Truth Establishment: Not applicable.

SUMMARY OF WHY MANY FIELDS ARE "NOT APPLICABLE":

This document describes a 510(k) submission for a physical therapy device (traction unit and infrared controller) aiming to demonstrate substantial equivalence to existing predicate devices. The requirements for such a submission are fundamentally different from those for novel AI algorithms or diagnostic devices, which typically involve extensive performance studies with specific acceptance criteria, test sets, ground truth establishment, and expert review. The "proof" in this context is the detailed comparison of the new device's characteristics, intended use, and compliance with standards against those of already cleared devices.

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