(110 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (as per 510(k)) |
|---|---|---|
| Substantial Equivalence | Same or similar basic characteristics, features, and intended use as predicate devices. | "The Dynatron DX2 shares the same or similar basic characteristics, features and intended use as the predicate devices and, therefore, is substantially equivalent to the Dynatron 900 Traction Unit and the Lordex Power Traction Unit (applicable 'K' numbers listed above) and the Dynatron 705 system console function for controlling infrared therapy devices." |
"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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.