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510(k) Data Aggregation
(70 days)
The OrthoPulse® device is intended to accelerate orthodontic movement of teeth which may reduce the overall treatment time for the patient. The OrthoPulse® device is intended for use during orthodontic treatment. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. The OrthoPulse device is an intra-oral appliance that is intended for use during orthodontic treatment in conjunction with traditional orthodontic treatment with brackets and wires or aligners. The device achieves its effect by delivering light energy to the bone, accelerating the rate of tooth movement. Light-emitting diodes ("LEDs") are embedded into the mouth-guard on a flexible circuit. Light is directed toward the alveolar surface to facilitate light treatment of the anterior arch segment during orthodontic tooth movement. The intra-oral appliance is designed to treat one arch (upper or lower), and is reversible by the patient to treat the other arch. OrthoPulse is considered a low level light treatment device and produces light at levels 50-80 mW/cm² for the patient. The device is designed to comply with applicable medical device standards. OrthoPulse includes light with wavelengths in the 850 nm range (near infrared) and the treatment protocol is based on a daily treatment session of 5 minutes per arch (maxilla or mandible). The treatment time (session duration) is controlled by the software (firmware). OrthoPulse includes an integrated battery for power. The battery is rechargeable via a wireless charging platform / storage case. OrthoPulse contains a Bluetooth LE transmitter module that operates at 2.4 GHz. This module is active only when the device is not in use, but placed in the charging case and the 'Ready for Bluetooth' indicator is on.
The provided text is a 510(k) premarket notification for the OrthoPulse 2.0E device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical efficacy study with human readers and ground truth established by experts.
The key takeaway from the document is that the manufacturer claims no clinical or animal studies were needed because the technical performance, materials, and principles of operation are stated to be the same as the predicate device. The changes are minor (larger mouthpiece, new battery with increased capacitance, new microcontroller, updated firmware), and the safety and performance were demonstrated through non-clinical tests (electrical safety, EMC, software verification and validation, specific battery and environmental temperature testing).
Therefore, I cannot provide a table of acceptance criteria for a clinical study or details about human reader performance (MRMC, standalone algorithm performance, number of experts for ground truth, adjudication methods) because such a study was explicitly stated as not conducted or needed for this 510(k) submission.
Here's what can be extracted from the document regarding the device's validation:
1. A table of acceptance criteria and the reported device performance:
Since no clinical efficacy study was conducted for this 510(k) submission, there are no "acceptance criteria" related to a clinical outcome or human-in-the-loop performance per se. The "acceptance criteria" were related to engineering and regulatory compliance, and these were met.
| Category | Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Patient contact materials and manufacturing processes are the same as the predicate. | No biocompatibility testing needed as all patient contact material and manufacturing processes for the relevant components (mouthpiece only) are the same. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-57 standards. | Full testing conducted to all standards the predicate device was submitted to. The device complies to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-57 standards. |
| Electromagnetic Harmony | Compliance with IEC 60601-1-2. | Full and complete EMC testing conducted according to standard IEC 60601-1-2. |
| Software Functionality | Software performs as intended, no failure or latent flaw results in injury to patient/operator, no dangerous situations caused by software failure. | Software verification and validation testing conducted according to FDA guidance. Software considered "minor" level of concern. Standard techniques (code review, regular testing) covered all specified states, device actions, and signals. Device and software ensure no dangerous situations. |
| Battery Performance | Sufficient duration for maximum treatment time; recharge within specified maximum time. | Testing conducted with three devices; successfully completed 2 full treatments (4 full sessions). All charge times were less than the specified maximum. Device continues to meet its specifications. |
| Environmental (Temperature) Safety | Device operates safely within specified temperature limits; automatically stops/shuts off when critical temperatures are reached; no hazardous states. | All specific features tested (mouthpiece internal temp, surface temp, battery charging temp, rigidboard temp, LED array temp, restart after cooldown). Testing successfully demonstrated device is as safe and effective as the predicate under all thermic conditions. |
| Overall Safety & Effectiveness | As safe and effective as the predicate device. | All tests conducted successfully. Favorable data supported the assumption that the device OrthoPulse 2.0E is as safe and effective as the predicate. Non-clinical data supports substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Battery Testing: 3 devices
- Environmental (Temperature) Testing: Not explicitly stated as a number of devices, but implies testing of the device's various temperature sensing and safety features. Likely performed on representative units.
- Electrical Safety, EMC, Software V&V: Typically performed on a limited number of engineering or production samples, not a "test set" in the clinical study sense.
- Data Provenance: Not specified as external data. This was internal validation testing conducted for the 510(k) submission. Therefore, the data would be "prospective" in the sense of being generated specifically for this submission's testing requirements. No country of origin for test data is specified, but the submitter is in Austria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission did not involve a clinical study with a "test set" requiring expert-established ground truth for performance evaluation against a clinical outcome. Validation was done through engineering and safety testing.
4. Adjudication method for the test set:
- Not applicable. No expert review or adjudication process was described or required for the type of bench and engineering testing conducted.
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:
- No. An MRMC study was not done. The device is not an AI/imaging diagnostic tool that assists human readers. It is a phototherapy device for accelerating orthodontic movement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable as the device is not an algorithm for diagnosis or image analysis. Its performance is related to its light emission, safety features, and battery life.
7. The type of ground truth used:
- Not applicable for clinical ground truth. The "ground truth" for the engineering tests was established by adherence to recognized consensus standards (IEC 60601 series), design specifications, and functional requirements of the device. For example, for battery testing, the "ground truth" was whether the device could run for the specified treatment duration and recharge within the specified time. For safety features, it was whether the safety mechanisms activated as designed under specific conditions.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set was used.
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