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The APOLLO IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The APOLLO IR Heat Lamp System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.

The APOLLO IR Heat Lamp System's 510(k) premarket notification (K060134) does not contain a study that proves the device meets specific acceptance criteria in the way described by your request. Instead, it relies on a demonstration of substantial equivalence to predicate devices already cleared by the FDA.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria or provide performance metrics in the format of a clinical study with results alongside those criteria. The clearance is based on equivalence to predicate devices and functional/safety testing, not on achieving specific clinical performance thresholds.

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

Not applicable. This document is a 510(k) premarket notification. It does not describe a clinical study with a "test set" of patient data for performance evaluation in the usual sense. The "testing" mentioned refers to functional performance and electrical safety of the device itself, not evaluation on a dataset representing patient cases or outcomes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no clinical study described that would require experts to establish ground truth for a test set of patient data.

4. Adjudication Method

Not applicable. As no clinical study on patient data is described, adjudication methods are irrelevant here.

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

No. The document makes no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The APOLLO IR Heat Lamp System is a physical therapy device that emits infrared energy, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI algorithm; it's a physical therapy device. Thus, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Not applicable. Since no clinical study on patient data is described for performance evaluation, there is no "ground truth" established in that context. The "truth" demonstrated for the device's functionality is its ability to emit infrared energy and comply with safety standards.

8. Sample Size for the Training Set

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

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

Not applicable.

Summary of Device Acceptance and "Study" Information from the Document:

Instead of a clinical study proving acceptance criteria, the 510(k) process for the APOLLO IR Heat Lamp System relies on the following:

• Intended Use Equivalence: The device is intended to emit infrared energy for topical heating, temporary relief of pain and stiffness, arthritis pain, muscle spasm, increased local blood circulation, and muscle relaxation. This intended use is stated to be similar to that of predicate devices.
• Technical Characteristic Equivalence: The APOLLO IR Heat Lamp System and the listed predicate devices (e.g., Meditech International Inc BioFlex Professional Therapy System, Thor International, Ltd. DDII Laser System) are all classified as "Infrared Lamps" (21 CFR 890.5500) and utilize infrared/visible laser diodes for topical heating. The submission states the device has "similar functional and performance characteristics" to these predicates.
• Functional and Safety Testing: The document states:
  • "Testing of the APOLLO IR Heat Lamp System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device."
  • "The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration."

Conclusion:

The "acceptance criteria" for the APOLLO IR Heat Lamp System, as presented in the 510(k) notification, are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and by confirming functional and electrical safety through standard testing. There is no clinical study, patient dataset, or AI performance evaluation described in this documentation. The FDA clearance (K060134) letter confirms that the device was found substantially equivalent to predicate devices for its stated indications for use.

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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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