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The EMA 3D is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar. Button hooks and bite blocks for the EMA 3D utilize standard dimensions. These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths: White-Soft, Yellow-Medium, Blue-Firm and Clear- Extra Firm. These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.

Based on the provided text, the device in question is the EMA 3D, an intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The substance of the application is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study or standalone algorithm performance. Therefore, the information provided focuses on non-clinical performance data and comparison to predicates rather than a clinical study with human readers or AI.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds for "Pass" or "Fail" for all tests. Instead, it states that "All testing was considered successful and met identified acceptance criteria" and "The EMA 3D passed all the testing in accordance with internal requirements, applied national standards, and applied international standards." The performance data is primarily qualitative and comparative to predicate devices concerning materials, design, and functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "testing" of the device components and materials. It does not specify sample sizes for these tests in terms of number of devices or patients. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature. The tests mentioned are laboratory-based material and component performance tests, not clinical studies on patient populations.

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)

This information is not applicable and not provided. The "ground truth" concept usually applies to clinical efficacy or diagnostic accuracy studies (e.g., for AI/image analysis devices). For a hardware device seeking 510(k) clearance based on substantial equivalence, the "ground truth" refers to the adherence to engineering standards and biocompatibility requirements rather than clinical consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this 510(k) submission as described.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance. This device is a physical intraoral appliance, not an AI or imaging device where such a study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no mention of a standalone algorithm performance. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established through adherence to recognized material and performance standards (e.g., ISO, ASTM for mechanical properties; ISO 10993 for biocompatibility) and demonstrable equivalence to predicate devices in terms of indications for use, technological characteristics, and safety profiles. It is not based on direct clinical outcomes data from new patient studies for this 510(k) submission.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device that would require a "training set."

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no training set for this type of device.

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TERA HARZ CLEAR is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e, all second molars). Utilizing a series of increments, it sequentially positions teeth by way of continuous gentle force. TERA HARZ CLEAR is intended exclusively for professional dental work. Fabrication of aligner with TERA HARZ CLEAR requires an additive manufacturing system (AMS) that includes compatible with the following :
Design:
Scanner 3Shape A/S TRIOS 3 Basic
Design software 3Shape A/S 3Shape Ortho System™
Printing:
3D Printer UNIZ SLASH 2
UNIZ Nbee
SprintRay Inc. SprintRay Pro 95
Post-Curing:
Post-cure unit CureM U102H
Tera Harz Cure THC

TERA HARZ CLEAR is a series of clear aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. TERA HARZ CLEAR have 3 models : TC-85DAC, TR-07, TA-28. This series of aligner is intended for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars) by moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. This series of aligner is worn for approximately 1 week of 20 to 22 hours per day after (However, there are to be removed for eating and for cleaning) which it is replaced by the next stage aligners and are designed to be used in a sequence. This is repeated for duration as prescribed by the dental clinician. TERA HARZ CLEAR is a light-cured, methacrylate-based resin commonly can used in additive manufacturing for the production of dental structures such as sequential aligners. TERA HARZ CLEAR has stored in a black 1,000 g of HDPE bottle. It contains materials with colors of yellowish. This device is a liquid photo-curable material that is polymerized by UV laser at 405412 nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (395405 nm) by the photo-initiator contained in the resin. It is typically 100 um in thickness and is output at a resolution of 40 to 90 um on the x, y axis, and it is possible to produce threedimensional printed matter by curing lamination step by step a thickness of 100 um. However, scanner, design software, 3D printer and post-cure unit are not included with the device. These fabrications of TERA HARZ CLEAR are beginning with the dental clinician prescribing aligners to treat a patient's malocclusion, and decision to use methacrylate- based resins is made by the dental clinician. TERA HARZ CLEAR, an orthodontic appliance such as sequential aligner, is manufactured in a 3D printer that is compatible. The dental clinician can generate a digital file by scanning the patient's mouth directly using listed with Intraoral scanner under FDA Classification Product Code NOF, regulation872.3661. This digital file is a series of CAD files (.stl) for building models that can be used to fabricate aligners. Commonly used standard dental software is used by dental professionals to virtually design a sequential aligner and generate an industrystandard "STL" 3D dataset which reflects the intended shape and contour. The design software used is 3Shape Ortho System™ by 3Shape A/S (K180941). The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470. This software is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of sequential aligners based on 3D scanned orthodontic models. Once dental clinic manufacturing unit receive the data that *.stl CAD files of the treatment plan the 3D printer begins additive manufacturing. The dental clinician generates sequential 3D printed models replicating the approved treatment plan. The sequential aligner is 3D printed and cured in a post-cure unit. The fabricated aligners are cut to fit dentition, the cleaned and polished to remove rough edges by the dental clinician. The prescribing physician review and approves the sequential aligners areprovides them to the patient the confirming fit and design.

The provided text describes the regulatory clearance of a dental device, "TERA HARZ CLEAR," an orthodontic plastic bracket (sequential aligner), by the FDA. The document focuses on demonstrating substantial equivalence to a predicate device, K180107 (Blue Sky Bio Aligner).

The information provided is primarily related to bench testing of material properties, rather than performance of an AI/ML algorithm or a multi-reader, multi-case study. Therefore, many of the requested points regarding AI/ML performance, ground truth establishment for AI models, and human reader studies (MRMC) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily derived from the ISO 20795-2:2013 standard, "Dentistry - Base Polymers - Part 2: Orthodontic base polymers." The device performance is compared to these criteria and the predicate device.

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The ApneaRx Pro is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.

The ApneaRx Pro is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space and minimizing air obstruction and turbulence. The device consists of two custom fabricated liners that fit separately over the upper and lower dental arches and engage in the posterior area of the mouth. The lower liner is snapfitted to a polycarbonate chassis that enables mandibular repositioning in 1 mm increments. The upper liner employs a hinged design to enable vertical movement of the jaws.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the ApneaRx Pro.

The document is a 510(k) summary for the ApneaRx Pro, which focuses on establishing substantial equivalence to a predicate device (ApneaRx). It describes the device, its intended use, and a comparison of technological features and materials between the new device and the predicate. Nonclinical testing for biocompatibility and physical properties of the materials is mentioned, stating that they met device specifications. However, there are no specific numerical acceptance criteria or details of a study designed to demonstrate performance against such criteria (e.g., clinical efficacy study for reduction of OSA or snoring, or a performance study with specific endpoints).

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and a performance study.

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