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Cristaline Aligners A FLX are series of clear, lightweight, plastic appliances, indicated for treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous force.

Cristaline Aligners Z FLX are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are manufactured using a biocompatible thermoplastic sheet composed of a composite of co-polyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides a digital file (scan) of the patient's teeth to Cristaline. Based on the dental health professional's treatment plan, Cristaline develops a digital plan using commercially available treatment planning software. Upon approval by the dental health professional, molds are created with 3D-printing technology and the clear aligners are formed on the molds. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design.

The provided document is a 510(k) Premarket Notification from the FDA for a device called "Cristaline Aligners Z FLX." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria as might be seen for novel devices.

Therefore, the document does not contain information regarding traditional acceptance criteria or a study that proves the device meets such criteria in the way a clinical trial would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device.

Here's an breakdown of the relevant information provided, specifically addressing your numbered points, and highlighting what is not applicable in this context:

1. A table of acceptance criteria and the reported device performance:
   As this is a 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics in the way a clinical study would define them (e.g., sensitivity, specificity, accuracy against a gold standard). The "acceptance criteria" here are met by demonstrating substantial equivalence to a predicate device.

   The table on pages 4 and 6 titled "SUBSTANTIAL EQUIVALENCE CONCLUSION" and "Substantial Equivalence Comparison Table" serves to compare the new device to the predicate device across various characteristics.

   Implicit "Acceptance Criteria" and "Reported Performance" (as per 510(k) standards):

   Characteristic	Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison)
   Indications for Use	Same as predicate device (Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX).	"Same for the Z FLX Aligner."
   Mode of Action	No differences from predicate device (removable appliance applies continuous gentle forces on teeth).	"No differences."
   Description of Use	No differences from predicate device (removable preformed plastic tray worn by patient for 1-2 weeks, prior to next sequential aligner tray).	"No differences."
   Material	Same as predicate device (Blue Sky Bio Aligner Z FLX - Thermoplastic co-polyester polyurethane composite).	"No differences."
   Manufacturing Process	Processes used are standard in the field and similar to predicate's (forming plastic sheets on 3D printed dental models designed with treatment planning software). Does not raise new questions of safety/effectiveness.	"Manufacturing processes used are standard in the field and similar to predicate's." Any differences do not raise new questions of safety and effectiveness.
   Software	Same commercially available treatment planning software as predicate.	"Same software is used."
   Prescription Use	Both are prescription use (Rx).	"Both are Rx."
   Biocompatibility	Testing to meet requirements for Category C, relying on the same testing performed by the thermoplastic material manufacturer as the predicate.	"Relied on the same testing performed by thermoplastic material manufacturer." (Passed In vitro Cytotoxicity, Oral Mucosal Irritation, Skin Sensitization per ISO 10993).
   Process Validation	Validation to determine fit and form of manufactured aligners, similar to predicate testing.	"Similar testing performed." (Bench testing performed to validate manufacturing process accuracy against digital scans).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   This document focuses on demonstrating substantial equivalence through comparison of materials, design, and manufacturing processes, rather than a clinical "test set" in the traditional sense.

   • Test Set Sample Size: Not applicable. The "testing" involved biocompatibility and bench testing.
   • Data Provenance:
     • Biocompatibility testing: Performed by a GLP-certified contract research laboratory. No specific country of origin is mentioned for the data, but the submitter (Cristaline Aligners GmbH) is based in Pforzheim, Germany.
     • Bench testing: Performed by the submitter. No specific country of origin is mentioned for the data.
     • The basis for substantial equivalence is comparison to the predicate device (Blue Sky Plan Software, Blue Sky Bio Aligner Z and Blue Sky Bio Z FLX; Blue Sky Bio, LLC).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   Not applicable. Ground truth as established by experts for a specific performance metric (like diagnostic accuracy) is not relevant to this 510(k) submission, which relies on engineering and biological safety testing, and comparison to a predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. There was no clinical "test set" requiring adjudication.

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:
   Not applicable. This device is an orthodontic aligner, not an AI diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is an orthodontic aligner. While its manufacturing involves "commercially available treatment planning software," the filing describes the aligner itself, not the software as a standalone AI algorithm for diagnostic purposes. The software is part of the manufacturing process to create the physical aligners.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable in the context of clinical performance ground truth. The "ground truth" for this submission revolves around:

   • Biocompatibility standards (ISO 10993).
   • Engineering validation of manufacturing accuracy against digital scans.
   • The established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.

9. How the ground truth for the training set was established:
   Not applicable. As above, this is not an AI/ML device with a training set.

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