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510(k) Data Aggregation
(113 days)
The DigiLine Direct Print Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The DigiLine Direct Print Aligner System repositions teeth by way of continuous gentle force.
The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental movements that move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.
The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each aligner stage is fabricated by additive manufacturing, specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-based resin. Methacrylate-based resins are commonly used for the production of dental structures.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Device Name: DigiLine Direct Print Aligner System
Regulation Name: Orthodontic Plastic Bracket
Product Code: NXC
Predicate Device: Tera Harz Clear (K223355)
Reference Device: LuxCreo Clear Aligner (K212680)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for device performance (e.g., a specific percentage of dimensional accuracy or a force measurement). Instead, it describes general compliance with standards and internal specifications. The performance is assessed by demonstration of manufacturing validation and material testing meeting requirements.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Manufacturing Validation | Capable of successfully fabricating the device; dimensional accuracy and quality of aligners meet pre-established criteria. | Manufacturing validation was performed, demonstrating the additive manufacturing process is capable of successfully fabricating the DigiLine Direct Print Aligner System. The dimensional accuracy and quality of the aligners resulting from the process met the pre-established acceptance criteria. |
| Material Testing | Meet internal design specifications and applicable performance standards (specifically ISO 20795-2:2013). | Material testing was conducted on the aligner material, meeting internal design specifications and the applicable performance standard ISO 20795-2:2013. |
| Biocompatibility | Meet requirements of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." | Biocompatibility testing was conducted for the aligner material (the only patient-contacting aspect) in accordance with ISO 10993-1. All testing met the requirements of the applicable standard. |
| Clinical Equivalence | The device is as safe, as effective, and performs as well as or better than legally marketed devices. | The conclusion from the non-clinical testing (manufacturing, material, biocompatibility) is that the DigiLine Direct Print Aligner System is as safe, as effective, and performs as well as or better than the legally marketed predicate and reference devices. Clinical testing was not required. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size for any test sets.
- Data Provenance: The document does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. Given that no clinical studies were performed, this information is not applicable to patient data. The non-clinical tests would have been performed in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This submission relies on non-clinical performance testing (manufacturing validation, material testing, biocompatibility) against established standards rather than clinical data requiring expert review for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical studies requiring expert review for ground truth were conducted, there was no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Testing was not required for the Predicate Device or the DigiLine Direct Print Aligner System."
- Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The device is a physical orthodontic aligner system, not an AI software.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The DigiLine Direct Print Aligner System is a physical orthodontic device manufactured using 3D printing. It is not an algorithm or AI software for which standalone performance would be measured. While a "digital scan" is used for design, the core device under review is the physical aligner.
7. Type of Ground Truth Used
- The "ground truth" for proving the device meets acceptance criteria is based on engineering standards, internal design specifications, and quality control metrics established for manufacturing, materials, and biocompatibility.
- Specifically:
- Compliance with ISO 20795-2:2013 for material performance.
- Compliance with ISO 10993-1 for biocompatibility.
- Demonstration of successful fabrication and meeting pre-established dimensional accuracy and quality criteria during manufacturing validation.
8. Sample Size for the Training Set
- Not applicable. This section relates to the training of an AI algorithm. The DigiLine Direct Print Aligner System is a physical medical device. The "design" phase involves digital scans and physician approval, but this is distinct from a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no AI algorithm training set for this physical device.
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(301 days)
Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.
The Park Dental Research Aligners device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
This document, K180648, is a 510(k) premarket notification for the "Park Dental Research Aligners." It appears to be a submission demonstrating substantial equivalence to a predicate device, rather than a submission for a novel artificial intelligence/machine learning (AI/ML) device that would typically involve extensive performance testing against acceptance criteria for AI algorithms.
Therefore, the provided text does not contain the information requested in points 1-9, as it describes a traditional medical device (clear aligners) and seeks clearance based on its similarity to an existing device, not based on AI/ML performance. The "Non-Clinical Performance Testing" section primarily discusses material biocompatibility and manufacturing validation related to software for fabrication, but this is not an AI/ML algorithm performance study.
Therefore, I cannot extract the requested information from the provided text.
To illustrate what a response would look like if the document contained AI/ML device performance data, here's a hypothetical structure and explanation of what each point would cover:
Hypothetical Acceptance Criteria and Study Proof (If this were an AI/ML device submission):
This section is not based on the provided document K180648, as the document does not describe the performance testing of an AI/ML algorithm for a medical device. It is a hypothetical example of what the requested information would look like if the submission were for an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Endpoints | ||
| Sensitivity (for Condition A Detection) | ≥ 90% | XX% |
| Specificity (for Condition A Detection) | ≥ 85% | YY% |
| Secondary Endpoints (if applicable) | ||
| AUC (for Classification) | ≥ 0.92 | ZZ |
| Agreement with expert readers (Kappa) | ≥ 0.80 | WW |
| Processing Time per case |
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(158 days)
Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.
Juell 3D Volo Base 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printed product is placed in a UV-light curing box for final polymerization.
3D printer is not included with the device.
The provided text describes a 510(k) premarket notification for a dental device, Juell 3D Volo Base. The device is a light-cured resin intended for the fabrication of denture bases using a CAD/CAM system. The submission argues for substantial equivalence to a predicate device, NextDent Denture/E-Denture.
However, the provided document does not contain information about a study that describes acceptance criteria, device performance against those criteria, or details regarding expert involvement, ground truth establishment, or sample sizes related to AI/ML device testing.
The document discusses "Bench Testing" in the context of material properties (Flexural Strength, Flexural Modulus, Water Solubility, and Residual Monomer) and states that "All test were passed" in compliance with ISO 20795-1 Type 4 Material. It also mentions biocompatibility. This is standard for material-based devices, not for AI/ML performance.
Therefore, I cannot provide the specific information requested about acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The device described (Juell 3D Volo Base) is a material, not an AI/ML system.
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