Search Results

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.

Ask a specific question about this device

The LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force.

LuxCreo Clear Aligner System is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state. A 3D printer, based on a 3D stereolithographic drawing, prints the predetermined shape of each aligner. Final polymerization is achieved by placing the printed aligner in a UV-light curing box. 3D printing uses specialty liquid resins, which help the aligners achieve mechanical properties similar to thermoplastics, and increased processability. The aligners are packaged and labeled according to the sequence in which they are intended for use, determined by the prescribing dental health professional. The finished set of aligners is shipped with six-month-shelf-life to the prescribing physician, who is accountable for ensuring the patient uses the device properly and safely.

This document is a 510(k) premarket notification for the LuxCreo Clear Aligner System and describes its substantial equivalence to predicate and reference devices. It details the device's indications for use, technological characteristics, and performance data from various tests. However, the document does not contain an acceptance criteria table with reported device performance in the context of device accuracy or clinical performance. Instead, it focuses on demonstrating substantial equivalence through comparisons of:

• Biocompatibility: The document lists several ISO 10993 tests performed (genotoxicity, cytotoxicity, subcutaneous implantation, oral mucosa irritation, pyrogenicity, skin irritation, skin sensitization, acute systemic toxicity, and sub-chronic systemic toxicity). It generally states that these tests indicated the light-cured polyurethane resin is safe to use and that the biocompatibility risks were considered.
• Physical and Mechanical Properties: The document provides values for flexural strength, flexural modulus, Shore D hardness, stress relaxation, water solubility, and water sorption for the proposed device and compares them to reference devices. The comparison often notes "Different" or "Similar" but does not explicitly state acceptance criteria or whether the new device met specific thresholds for these properties.
• Manufacturing Process and Materials: The document highlights the light-cured 3D printing process and light-cured polyurethane resin used for the LuxCreo system, comparing it to the thermoforming process and different materials of predicate devices. It states that "The difference in manufacturing process and base materials did not raise other safety and efficacy concerns" and that these differences "have been tested and validated."
• Design Verification, Validation, and Manufacturing Validation: The document broadly states that these were "completed" and "All the results meet the product specification requirements." However, specific acceptance criteria and detailed results are not provided in this summary.
• Transportation and Accelerated Aging Tests: These were validated and completed.

Based on the provided text, the following information can be extracted:

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

The document does not explicitly provide a table of acceptance criteria for device performance (e.g., accuracy, clinical efficacy metrics for orthodontic treatment) alongside the reported performance. Instead, it presents various test results for material properties and general statements regarding biocompatibility and manufacturing validation. The comparisons made are primarily to predicate and reference devices to establish "substantial equivalence," not to pre-defined performance acceptance criteria stated within this summary.

Here's a compilation of the reported physical and mechanical properties:

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

The document does not specify sample sizes for any of the tests conducted (biocompatibility, physical/mechanical properties, transportation, aging, design/manufacturing validation). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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 provided in the document. The studies described are primarily material and device characterization tests, not clinical evaluations requiring expert interpretation of patient data to establish ground truth.

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

This information is not applicable and not provided. The document describes laboratory testing and validation, not studies requiring expert adjudication for a test set.

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

This information is not applicable and not provided. The LuxCreo Clear Aligner System is a physical medical device (clear aligners) and not an AI-assisted diagnostic tool or software designed to assist human readers.

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

This information is not applicable and not provided. As mentioned above, this device is a physical clear aligner system, not an algorithm, and the application is not an AI-driven standalone system. While it states software is used for ordering workflow, the performance data provided relates to the physical characteristics and safety of the aligners themselves.

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

The concept of "ground truth" as typically applied to diagnostic algorithms or clinical outcomes data is not directly relevant to the performance data presented here. The "ground truth" for the material and physical property tests would be established by the standardized methods and measurements specified (e.g., ASTM D790, ISO 20795-2, ISO 10993 series for biocompatibility). The "truth" for these tests are the measured values themselves as determined by the specific testing protocols.

8. The sample size for the training set

This information is not applicable and not provided. The document describes a physical medical device and its material properties, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Ask a specific question about this device

EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

The EndSnorZ Sleep Appliance is a mandibular advancement device. It holds the mandible in a protrusive position determined by the trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin, and a connector, made of a biocompatible medical-grade synthetic polymer with injection molding technology. The connectors attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 0.5 mm increments. The device is customized to conform to the patient's upper and lower dentition, provided to Prismatik in patient scans. After loading the patient's scan, the splints are designed according to the scan and the clinician's prescription. Prismatik's computer aided design (CAD) software is used for the design phase. The connectors are applied after the splints are manufactured. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.

This document is a 510(k) premarket notification for a medical device called the EndSnorZ™ Sleep Appliance. It asserts substantial equivalence to a predicate device, the Silent Nite sl. The document describes laboratory testing and biocompatibility assessments to support this claim, rather than a clinical study evaluating the device's performance in humans against specific acceptance criteria.

Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a clinical trial or performance evaluation with human subjects is not present in the provided text. The document focuses on demonstrating substantial equivalence through comparison to existing devices and laboratory testing of materials and mechanical properties.

However, I can extract information related to the device and the testing performed to support its substantial equivalence, which is a form of "proof" in the regulatory context.

Here's an interpretation based on the provided text, addressing the points where information is available and noting where it is not:

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

The document does not present specific clinical acceptance criteria (e.g., a certain percentage reduction in AHI or snoring events) as it is not a clinical performance study with human outcomes. Instead, the "acceptance criteria" for this 510(k) submission are implied to be the demonstration of substantial equivalence to the predicate device through:

• Identical/Similar Indications for Use: The device aims to address the same clinical need as the predicate.
• Similar Technological Characteristics: The device functions similarly and is made of biocompatible materials with comparable mechanical properties.
• Fulfillment of Biocompatibility and Mechanical Testing Standards: Meeting established safety and performance standards for materials.

Here's a table summarizing the reported device performance in the context of substantial equivalence, based on the comparative testing and characteristics mentioned:

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

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical samples of the device and its components used for laboratory/bench testing. The number of samples for these tests (tensile strength, dimensional retention, biocompatibility) is not explicitly stated, but it would have been conducted under GLP (Good Laboratory Practice) guidelines.
• Data Provenance: The testing was performed by Prismatik (the manufacturer) and contracted labs for biocompatibility testing. The location of these labs is not specified, but the submission is to the U.S. FDA. The testing is prospective in the sense that it was conducted for this specific submission to demonstrate equivalence.

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. The ground truth for this submission is based on laboratory measurements and adherence to engineering/material standards (e.g., ISO 10993) and comparison to the predicate device's established characteristics. No expert clinical review of "ground truth" (e.g., diagnosis of OSA severity or snoring levels) from human patients was required or performed as part of this specific 510(k) submission.

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

• Not applicable. This concept pertains to multi-reader studies where disagreements among expert readers need to be resolved. This submission is based on laboratory testing and comparison to a predicate, not human image interpretation or clinical outcomes.

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 performed. This device is a physical intraoral appliance, not an AI or image analysis tool for diagnosis where human reader performance would be assessed.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• The "ground truth" for this 510(k) submission is derived from:
  • Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (Silent Nite sl).
  • Laboratory/Bench Testing Standards: Defined metrics and acceptable ranges for material properties (e.g., tensile strength) and biocompatibility, as per ISO standards and engineering principles.
  • Manufacturing Validation Data: Confirmation that the manufacturing process consistently produces the device according to design specifications.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML algorithm for which this information would be relevant.

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

• Not applicable. There is no training set mentioned in this context.

Ask a specific question about this device