(59 days)
FREEPRINT® splintmaster is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment. FREEPRINT® splintmaster is indicated for the fabrication, by additive manufacturing, of orthodontic and dental objects such as mouthguards, splints, and repositioners.
The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce dental mouthguards, nightguards, splints, and repositioners. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment.
The Subject device is used by a dental professional (dentist or dental technician) for the additive Computer-Aided Manufacturing (CAM) of dental mouthguards, nightguards, splints, and repositioners. There are two models of the Subject device which are referred to as FREEPRINT® splintmaster flex and FREEPRINT® splintmaster taff with slightly different material properties for either a more flexible or rigid final product.
The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.
The provided text describes a 510(k) premarket notification for a medical device called FREEPRINT® splintmaster. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets them.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses:
- Indications for Use: What the device is intended for (fabrication of orthodontic and dental objects like mouthguards, splints, and repositioners).
- Device Description: It's a light-cured methacrylate-based resin used in 3D printers.
- Equivalence to Marketed Devices: Comparison of the subject device with predicate devices (GR Splint Resin System, KeyPrint KeySplint Soft, KeyPrint KeySplint Hard) in terms of indications for use and technological characteristics.
- Non-Clinical Performance Testing: Mentions that physical property testing was performed to ISO 20795-2, and biocompatibility testing was done to ISO 10993 standards. It also states that "Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above."
Missing Information:
Crucially, the document explicitly states:
- "No clinical or animal testing data is included in this submission."
- It does not provide a table of acceptance criteria, specific performance numbers for the device against those criteria, or details regarding the methodologies for setting ground truth, expert qualifications, sample sizes for test or training sets, MRMC studies, or standalone performance.
**Therefore, I cannot fulfill your request for: **
- A table of acceptance criteria and the reported device performance: This detailed information is not present. The document only broadly states that the device met acceptance criteria for non-clinical tests.
- Sample sizes used for the test set and the data provenance: Not specified, as clinical data was not included. "Test set" here refers to non-clinical chemical and mechanical tests, not a clinical dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as ground truth typically refers to clinical diagnosis or outcomes, which were not part of this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical material testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Explicitly stated "No clinical or animal testing data is included."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a material (resin) for dental manufacturing, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it's not a diagnostic device or AI. The "ground truth" for the material is its physical and chemical properties as measured by ISO standards.
- The sample size for the training set: Not applicable, as no AI model was described requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document is a clearance letter for a 3D printing resin based on engineering and material property testing, rather than an AI/diagnostic device that would typically involve the detailed study information you are asking for.
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