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A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.

The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.

The provided text serves as a 510(k) summary for the Dynatron Peltier ThermoStim device, which is a combination electrical stimulation and thermal therapy probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the manner typically found in a clinical trial.

Therefore, the requested information, particularly regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and comparative effectiveness data with human readers, is not present in the provided document. The document primarily describes the device's technical specifications and compares them to a predicate device to establish substantial equivalence for regulatory approval.

However, I can extract the general performance characteristics and the basis for the declaration of substantial equivalence, which can be interpreted as implicitly meeting regulatory acceptance.

Here's what can be inferred from the document:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, "acceptance" is implicitly based on demonstrating that the Dynatron Peltier ThermoStim probe performs "equivalently" to the predicate device, Dynatron ThermoStim probe (K120835). The performance characteristics are compared in relation to the predicate's known performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical Bench Testing" and "Thermal data was collected." However, it does not specify the sample size of devices tested or the number of measurements taken for either the electrical stimulation waveform analysis or the thermal data collection. The data provenance is implied to be from Dynatronics' internal testing ("Non-clinical Bench Testing"), likely in the USA where the company is located. The nature of the testing (bench testing) is prospective for these measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The device is purely a physical therapy accessory and likely does not involve diagnostic interpretation by experts for its core function. The "ground truth" for the performance tests (waveform analysis, temperature measurements) would be established by calibrated measurement equipment, not expert opinion.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need resolution. Since this document describes bench testing of a physical device, such adjudication methods are not relevant.

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 information is not provided and not applicable. The Dynatron Peltier ThermoStim is a physical therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are outside the scope of this device.

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

This information is not applicable. The device is a physical therapy probe that inherently requires human-in-the-loop operation by a practitioner. There is no "algorithm only" performance to evaluate in this context.

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

For electrical stimulation waveform analysis: Comparison against expected, known waveforms from the predicate device and the controlling Solaris console. The "ground truth" is the established electrical signal parameters.
For thermal data: Calibrated temperature measurements. The "ground truth" is the actual measured temperature by sensors.
For safety standards: Compliance with international safety standards (EN60601-1, EN60601-1-2). The "ground truth" is adherence to these normative standards.

8. The sample size for the training set

This information is not provided and not applicable. The Dynatron Peltier ThermoStim probe does not utilize machine learning or AI models that require a "training set" of data.

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

This information is not provided and not applicable as there is no training set for this type of medical device.

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A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin

The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.

The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.

There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).

This document describes the Dynatron ThermoStim Combination Electrical Stimulation and Thermal Therapy probe and its substantial equivalence to predicate devices, rather than a clinical study establishing its performance against acceptance criteria in the manner requested.

However, based on the provided text, I can extract and infer information relevant to your request regarding acceptance criteria and performance, primarily from the "Performance Characteristics" and "Non-clinical Bench Testing" sections.

The device is intended to provide therapeutic electrical stimulation and thermal therapy (hot and cold). The "acceptance criteria" here are implied by the desired therapeutic ranges and the device's ability to deliver these. The study described is a non-clinical bench test comparison.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "two body parts per patient" for the thermal data collection. There is no explicit number of patients or total "test set" samples (e.g., number of probes tested, number of measurements taken for waveforms, or number of patients if clinical). The electrical waveform analysis compares the ThermoSTIM probe to a predicate, implying at least one of each was tested.
• Data Provenance: Non-clinical bench testing. No country of origin is specified, but the submission is to the U.S. FDA by a U.S. company. The testing is retrospective in the sense that it evaluates the manufactured device; it is not a prospective clinical trial.

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

• This document describes non-clinical bench testing. Therefore, "ground truth" is established by measurement instruments (e.g., oscilloscopes, thermometers) and engineering standards (EN60601-1, EN60601-1-2). No human experts are explicitly mentioned for establishing a ground truth for the test set beyond the engineering team conducting the tests and interpreting the instrument readings against specified criteria.

4. Adjudication Method for the Test Set

• Not applicable as it's non-clinical bench testing involving objective measurements against defined engineering standards and electrical/thermal targets. There is no human subjective assessment or adjudication process described.

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

• No, a MRMC comparative effectiveness study was not done. This document primarily focuses on demonstrating substantial equivalence through non-clinical bench testing, comparing the new device's technical performance characteristics to existing predicate devices and safety standards. There is no mention of human readers or AI assistance in this context.

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

• Not applicable. This device is a manual therapy accessory that requires a human practitioner to apply it. It is not an algorithm-only device or an AI system. The "standalone" performance here refers to the device's ability to deliver electrical and thermal energy as designed, which was evaluated in the bench tests.

7. The Type of Ground Truth Used

• The ground truth for the non-clinical bench testing was primarily objective physical measurements (electrical waveforms, temperature readings) compared against engineering specifications and regulatory standards (e.g., EN60601-1, EN60601-1-2).

8. The Sample Size for the Training Set

• This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The device's design and manufacturing processes are refined through engineering development and testing.

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

• As above, this is not an AI/ML algorithm, so there is no "training set" or establishment of ground truth for a training set in that context. The device's "training" or development involves iterative design, prototyping, and engineering validation to meet design specifications and regulatory requirements.

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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® Ion™ iontophoresis electrode is designed for clinical use to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
The Dynatron® Ion™ iontophoresis electrode is indicated to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection

The Dynatron® Ion™ iontophoresis electrode consists of an active drug delivery electrode and a return electrode. Electrodes are designed for single patient use.

This 510(k) submission does not contain a study to prove acceptance criteria were met. Instead, it relies on substantial equivalence to a predicate device.

Here's why and what information is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance for the Dynatron® Ion™ iontophoresis electrode in this document. The submission asserts "substantial equivalence" to a predicate device rather than presenting performance data against defined criteria.

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

No test set was used for this device as detailed in the submission. The submission relies on substantial equivalence.

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

Not applicable. No test set was used for performance evaluation against ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was conducted. The submission does not compare the new device's performance to human readers with or without AI assistance.

6. Standalone Performance Study:

No standalone (algorithm only without human-in-the-loop performance) study was conducted for the Dynatron® Ion™ iontophoresis electrode.

7. Type of Ground Truth Used:

Not applicable. No ground truth was established for a testing phase of this device, as its approval is based on substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML device and therefore does not have a "training set."

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

Not applicable. As above, this is not an AI/ML device and does not involve a training set with established ground truth.

Summary of the Submission's Approach:

The submission for the Dynatron® Ion™ iontophoresis electrode is a 510(k) premarket notification which seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (the North Coast Buffered Iontophoresis Electrode, cleared under K052019).

The core argument for safety and effectiveness is that:

• "The Dynatron® Ion™ iontophoresis electrode shares the same or similar basic characteristics, features and intended use as the predicate device"
• "There are no substantive differences between the product defined in this 510(k) submission and the predicate device."
• "They are similar to the technologies that are currently used in other similar medical devices."
• "The product is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program."

Therefore, no new studies or performance data are presented to establish acceptance criteria or demonstrate the device's performance against such criteria. The device's safety and effectiveness are inferred from its similarity to an already cleared device.

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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

"There are no substantive differences between the products defined in this 510(k) submission and the predicate device. They are similar to the technologies that are currently used in other similar medical devices." |
| Intended Use | Intended Use/Indications for Use consistent with cleared indications for predicate devices. | "The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices." |
| Performance Standards | Conforms to applicable requirements of 21 CFR 1010 (Performance Standards for Electronic Products: General). | "The Dynatron DX2 device conforms to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General)." |
| Safety and Effectiveness | Device is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program. | "The products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program." (This is asserted based on similarity to predicate devices and being developed under a Quality Management System). |
| Quality System | Developed and documented under a mature Quality Management System (21 CFR Part 820), under design/change control, and verified/validated to applicable standards/guidance. | "They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and are verified/validated to applicable standards/guidance documents." |

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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Infrared 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® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy. Components: System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays. Infrared pad, model Dynatron Xp, for administering IR therapy. Hand-held infrared probe, model D405, for administering IR therapy. Accessories such as power cord.

The provided text is a 510(k) premarket notification for the Dynatron® Solaris™ Series of infrared therapy devices. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness. Therefore, the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details will not be found in this document.

The document explicitly 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."
• "They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and are verified/validated to applicable standards/guidance documents."

This indicates that the manufacturer is relying on the established safety and effectiveness of the predicate device (Dynatron® Solaris™ D705 and accessory D880 IR Probe, cleared under K031329) and adherence to general performance standards and regulations.

Therefore, I cannot extract the requested information as it is not contained within this 510(k) submission.

What can be extracted is information related to the device itself and its regulatory status:

Summary of Device and Regulatory Context (from the provided text):

• Device Name: Dynatron® Solaris™ Series (models Dyntron X3, Xp, D405); Infrared therapy.
• Intended Use/Indications For Use: Topical heating via infrared therapy for temporary increase in local 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.
• Predicate Device: Dynatron® Solaris™ D705 and accessory D880 IR Probe (cleared under K031329).
• Basis for SE: The devices share the same or similar basic characteristics, features, and intended use as the predicate.
• Safety and Effectiveness Rationale: No substantive differences from the predicate, similar to other currently used medical devices, developed under Dynatronics' Quality Management System, and verified/validated to applicable standards/guidance documents.
• Regulatory Class: Class II, Product Code ILY.
• FDA Determination Date: July 25, 2005.

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The Dynatron® IBox™ is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

The Dynatron® IBox™ is an iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

The Dynatron® IBox™ is a battery powered, solid state, microprocessor-controlled unit that delivers measured, displayed direct current as defined by the user. Treatment duration is also measured and displayed.

The device connects to any number of existing electrodes cleared for marketing in the United States that have a common snap connection. Device output is functionally identical to predicate devices.

The provided text is a 510(k) premarket notification for the Dynatron® IBox™ Iontophoresis device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving comprehensive clinical effectiveness through studies with acceptance criteria in the manner typically seen for novel devices.

Therefore, the submission does not contain information about specific acceptance criteria for device performance or a study demonstrating the device meets such criteria. Instead, it asserts that the device is "functionally identical to predicate devices" and "substantially equivalent" to them.

Here's why the requested information cannot be fully provided from the given text:

• Acceptance Criteria & Reported Performance: The document does not define specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the Dynatron® IBox™ or report any test results against such criteria. The "performance standards" mentioned refer to 21 CFR section 1010, which states that iontophoresis devices are not designated under performance standards requirements.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements of studies designed to assess direct clinical or analytical performance. Since the 510(k) relies on substantial equivalence and states the device is "functionally identical to predicate devices," it does not include new clinical or analytical study data of this type for the Dynatron® IBox™.

Based on the provided text, here's what can be stated:

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

   • Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., accuracy, precision) for this specific device in the submission. The submission relies on "substantial equivalence" to predicate devices and asserts functional identity.
   • Reported Device Performance:
     • "Device output is functionally identical to predicate devices." (Claim)
     • The device "delivers measured, displayed direct current as defined by the user."
     • "Treatment duration is also measured and displayed."

2. Sample size used for the test set and the data provenance: Not applicable. No new clinical or analytical test set or data provenance is detailed for the Dynatron® IBox™ in this substantial equivalence submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new clinical or analytical test set requiring expert ground truth establishment is detailed.

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 device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for direct current delivery, not an algorithm.

7. The type of ground truth used: Not applicable. The submission focuses on functional equivalence to predicate devices, not on proving clinical efficacy or diagnostic accuracy with a specific ground truth.

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or complex analytical models.

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

In summary: The provided document is a 510(k) summary for a Class III Iontophoresis device seeking clearance based on substantial equivalence. It highlights the device's functional similarity to existing cleared devices rather than presenting new clinical study data with defined acceptance criteria.

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Infrared 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 Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.

The provided FDA 510(k) summary for the Solaris D890™ Therapy Probe does not contain information about a study that establishes acceptance criteria or reports device performance in the way a clinical study would for a novel medical device.

Instead, this submission leverages the substantial equivalence pathway, which means the device's safety and effectiveness are established by demonstrating its similarity to a legally marketed predicate device, the Solaris D880 Infrared Probe (K031329).

Therefore, many of the requested fields regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable or not explicitly detailed in this type of submission.

Here's how the provided information relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (NA)

The 510(k) summary does not define specific performance acceptance criteria for clinical outcomes or efficacy endpoints. Instead, the acceptance is based on the device conforming to applicable regulatory standards for electronic and light-emitting products, and being substantially equivalent to the predicate device in terms of technology, intended use, and indications for use.

The "reported device performance" in this context refers to the device's technical specifications and how they align with regulatory requirements and the predicate device, rather than performance data from a clinical trial.

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

Not Applicable (NA)

No clinical test set or data provenance is detailed in this 510(k) summary. The submission relies on establishing substantial equivalence to a predicate device.

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

Not Applicable (NA)

No clinical test set requiring expert ground truth establishment is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not Applicable (NA)

No clinical test set requiring an adjudication method is described in this 510(k) summary.

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 (NA)

This device is an infrared therapy probe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.

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

Not Applicable (NA)

This device is an infrared therapy probe and does not involve a standalone algorithm for performance testing.

7. The Type of Ground Truth Used

Not Applicable (NA)

As no clinical study or test set requiring ground truth is detailed, no specific type of ground truth is mentioned. The "ground truth" for this submission revolves around regulatory compliance and technical similarity to the predicate device.

8. The Sample Size for the Training Set

Not Applicable (NA)

No training set for an algorithm is described in this 510(k) summary as it is not an AI/algorithm-based device.

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

Not Applicable (NA)

As no training set is described, the method for establishing its ground truth is not applicable.

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The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy.

1. Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
2. Transcutaneous electrical nerve stimulation and Interferential Current Therapy for: Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
3. Ultrasound therapy for: Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as: Relief of pain Muscle spasms Joint contractures
4. Infrared 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® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy. Components: System console, containing software and control electronics with alpha-numeric displays Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy Accessories such as patient cables, electrodes, transducer gel and elastic straps.

The Dynatron® Solaris™ Series (models 709, 708, 706, and 705) are therapeutic devices offering electrical stimulation, ultrasound, and/or infrared therapy. The document K031329 confirms their safety and effectiveness through substantial equivalence to predicate devices, following the FDA's 510(k) premarket notification process.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the acceptance criteria are implicitly met through demonstrating Substantial Equivalence (SE) to legally marketed predicate devices. The "reported device performance" is the confirmation of this substantial equivalence.

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

The document does not describe a "test set" in the context of a prospective clinical study with a defined sample size. The substantial equivalence determination is based on a comparison to existing predicate devices.

• Sample Size for Test Set: Not applicable or not explicitly stated as a separate test set with specific patient data. The "sample" is effectively the design, specifications, and performance characteristics of the new devices being compared to existing, cleared devices.
• Data Provenance: Not applicable in the sense of patient data. The "data" pertains to the technical specifications, intended uses, and safety/performance characteristics of the devices themselves, derived from their design documentation, manufacturing processes, and compliance with performance standards. This is not retrospective or prospective patient data from a clinical trial.

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

This information is not applicable as the document does not describe a study involving human experts establishing "ground truth" on a test set of patient cases. The "ground truth" for predicate devices is established by their prior clearance through the FDA and their safe and effective use in the market.

4. Adjudication Method for the Test Set

This information is not applicable as there is no specific "test set" and no "ground truth" arbitration process described for a diagnostic or AI performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done and is not described in the document. This type of study is typically performed to evaluate the impact of an AI diagnostic tool on human reader performance, which is not the subject of this 510(k) submission.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

A standalone performance study was not done and is not described. The devices in question are physical therapeutic devices (electrical stimulators, ultrasound, infrared) and not AI algorithms or diagnostic software that would undergo standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" in this context is established by the prior FDA clearance of the predicate devices. The new devices (Dynatron Solaris Series) are deemed safe and effective because they are substantially equivalent to devices already recognized as safe and effective by regulatory bodies. It's not based on pathology, outcomes data, or expert consensus on new patient data for the new devices, but rather on the established performance and regulatory status of the predicate devices.

8. Sample Size for the Training Set

This information is not applicable. The devices are not AI or machine learning models that require a "training set."

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

This information is not applicable for the same reasons as point 8.

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