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The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The Remi Custom Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

This document is a 510(k) Premarket Notification from the FDA regarding a dental device called the "Remi Custom Night Guard." It states that the device is substantially equivalent to a legally marketed predicate device (LIJIA Night Guard), meaning a full clinical study with acceptance criteria and a detailed study report is not required.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document explicitly states:

• "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." (page 6)

Instead, the submission relies on:

• Comparison to a Predicate Device: The Remi Custom Night Guard is shown to have the same indications for use, product code, classification, anatomical sites, sterility, patient removability, and general technological features as the predicate LIJIA Night Guard (K241369).
• Non-Clinical Performance Testing:
  • Durability testing: Completed, but no details on specific acceptance criteria or results are provided.
  • Internal manufacturing validation: Performed to test the dimensional accuracy of the manufacturing process, but no specific acceptance criteria or results are provided.
  • Biocompatibility testing: Performed in accordance with ISO 10993, with cytotoxicity testing completed. No specific acceptance criteria or results are provided beyond the statement that it was completed.

In summary, because this is a 510(k) submission based on substantial equivalence to a predicate device and explicitly states that no clinical studies were deemed necessary, the detailed information about acceptance criteria and a study to prove device performance (as requested in the prompt) is not present in this document.

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Fas Aligner System is intended for the orthodontic treatment of malocclusion.

Fas Aligner System consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. This removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. Fas Aligner System are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist).

Fas Aligner System 's staff in the Prescription and Planning area create the virtual planning including the attachments, as well as the movements they consider necessary to achieve the intended tooth correction. For this process the following previously released software Nemocast (K232549).

The 3D specialists use the planned data to produce the complete product design. The responsible of the Planning/Prescription department reviews the design to verify that it has been done as required and, if necessary, proposes changes.

Once the design has been approved by the clinician, the next phase of printing and preparation of models is carried out. This phase takes place in the Printer Room and is carried out by 3D Printing Technicians. For the entire manufacturing process, the models are identified with the clinical case number.

The thermoforming equipment is used for the manufacturing process of the aligners. The printed model is placed on the platform and the thermoforming sheet is placed, which is made with material previously released by means of the K200125 (Erkodur).

Once the printed thermoforming sheet is obtained, the contour of the thermoforming sheet is cut out, eliminating the edges. The gingival margins are trimmed.

The product is not sent sterile, it is cleaned to remove all residues that may have remained from the manufacturing process.

The product, the splint, is placed in labeled bags. The aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Fas Aligner System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the Fas Aligner System itself. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for the Fas Aligner System is not explicitly provided in this document.

However, based on the non-clinical testing summary, we can infer some information about general performance and safety criteria, primarily through comparison to the predicate device and relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" for the Fas Aligner System are primarily that its technological characteristics and performance are comparable to the predicate device, Nuvola® Aligner (K222418), and that it meets relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable/Not provided for the Fas Aligner System in this document. The document describes non-clinical testing (durability, manufacturing validation, biocompatibility) but does not refer to a "test set" of patient data for performance evaluation in the way a clinical study would.
• Data Provenance: The durability and manufacturing validation tests were "internal." The biocompatibility testing followed ISO standards. The material characterization references K200125, which would contain its own original data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• This information is not provided as no clinical or comparative performance study using human readers/experts to establish ground truth is described. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material properties, manufacturing robustness, and biocompatibility, as verified by technical personnel during the internal tests.

4. Adjudication Method for the Test Set

• Not applicable/Not provided as there is no described test set requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not conducted or presented in this submission. The document explicitly states: "No clinical testing was performed in support of this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study of the Fas Aligner System (as a whole device) or its underlying planning algorithm was not conducted or presented. The submission focuses on the substantial equivalence of the physical aligners and manufacturing process, and acknowledges the use of FDA-cleared Nemocast software for planning, but does not present a standalone performance evaluation of that software in the context of this submission.

7. Type of Ground Truth Used

• For the non-clinical tests described:
  • Durability and Manufacturing Validation: The "ground truth" would be established engineering specifications and internal quality standards for mechanical integrity and process robustness as validated through internal testing.
  • Material Characterization: Scientific and engineering standards for material properties.
  • Biocompatibility: International standard ISO 10993-1 and ISO 10993-5, representing accepted biological safety benchmarks.

8. Sample Size for the Training Set

• Not applicable/Not provided. This submission does not describe a machine learning algorithm developed by Xplora 3D Europe S.L. for which a training set would be relevant. The planning software mentioned (Nemocast) is a previously cleared device (K232549), and any training data for that software would have been part of its original submission.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided. See point 8.

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The JS Dental Lab Mouth Guard is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

The JS Dental Lab Mouth Guard (herein referred to as Subject Device) is a patient contact protective custom-fit mouth guard that covers the upper teeth and lower teeth to prevent premature tooth wear and noise caused due to bruxism and teeth grinding. It fits over upper teeth or lower teeth during sleep. The Subject Device can offset the effects of bruxing or teeth grinding while protecting teeth from daily wear and tear. The Subject Device is created based on the user's teeth impression and manufactured using the biocompatible material, equivalent to the Thermoformed Mouthguards/Nightguards (herein referred to as Predicate Device, K121365). The Subject Device contains biocompatible materials, namely, Erkodur or Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA Based Clear Mouthguard Material and BIOPLAST and is available in four different variations. All the biocompatible materials used are ISO-certified, BPA-free, and are cleared for dental use in humans.

The provided document is a 510(k) premarket notification for a medical device, the "JS Dental Lab Mouth Guard." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for AI performance.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI-powered device.

The JS Dental Lab Mouth Guard is a physical dental device (a mouthguard), not an AI-powered software or algorithm. The review process for such a device focuses on material biocompatibility, physical properties, and a comparison of its technological characteristics and indications for use to an existing predicate device.

Specifically, the document focuses on:

• Device Description: A custom-fit mouth guard for bruxism and teeth grinding.
• Materials: Biocompatible materials like Erkodur, Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA-based clear mouthguard material, and BIOPLAST.
• Comparison to Predicate: Demonstrating substantial equivalence to "Thermoformed Mouthguards/Nightguards (K121365)" in terms of indications for use, design, materials (with some minor differences noted as not raising new questions of safety and efficacy), reusability, single-patient use, manufacturing method, and sterility.
• Biocompatibility Testing: Confirmation of material biocompatibility according to ISO 10993-1:2018.
• Bench Performance Testing: Stating that physical properties for the materials have been provided by the material manufacturer.

There is no mention of any AI component, algorithm, or software in this submission. Consequently, there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" establishment by experts, and no "MRMC comparative effectiveness study" for AI assistance.

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Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. It 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 Silent Nite Sleep Appliance with the Glidewell Hinge is a mandibular advancement device. It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep. The device consists of upper and lower trays, which are fabricated using a biocompatible dual-layered thermoplastic material, and an engaging mechanism, which is the Glidewell Hinge (biocompatible medical grade stainless steel bars), and band lugs and hooks for attaching the optional orthodontic (elastic) bands, which are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the jaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug. The device is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays. The difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors. 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.

The provided text is a 510(k) Summary for a medical device called the "Silent Nite Sleep Appliance with the Glidewell Hinge." It describes the device, its intended use, and how it compares to a predicate device to establish substantial equivalence for FDA clearance.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them, primarily focusing on the engineering and material performance rather than clinical efficacy studies, as this is a 510(k) submission for a physical device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria detailed in the document are primarily related to the device's functional integrity, fit, and material biocompatibility. Clinical efficacy (e.g., reduction in AHI) is established through the similarity to the predicate device, not through new clinical trials described here.

1. Table of Acceptance Criteria and Reported Device Performance:

• Device design allows for advancement to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. This indicates the function works as intended. |
  | | Maximum hinge displacement (mm) correct | - Verification testing conducted by Prismatik Dentalcraft, Inc.
• Specific maximum displacement (up to 10mm) is stated, implying it meets this range. |
  | | Hinge placement/positioning correct | - Verification testing conducted by Prismatik Dentalcraft, Inc. |
  | | Device fits and retains to the model | - Validation testing showed acceptable performance.
• Customized to conform to the patient's upper and lower dentition based on clinician's prescription; models are made and used during thermoforming fabrication. |
  | | Hinge is well attached to the trays | - Validation testing showed acceptable performance. |
  | | Device's final finish is smooth and free of roughness or burs | - Validation testing showed acceptable performance. |
  | Biocompatibility | Materials meet ISO 10993 requirements (trays) | - ISO 10993 testing performed on Thermoforming Sheet Materials (documented in Reference device K200125).
• Material is safe and biocompatible for "fabrication of orthodontic and dental appliances."
• Tests include Cytotoxicity and Irritation (implied, as it matches predicate's requirements). |
  | | Materials meet ISO 10993 requirements (stainless steel hinge)| - ISO 10993 testing conducted on the stainless steel hinge component:
  • In vitro Cytotoxicity (Part 5): Met requirements.
  • Guinea Pig Maximization Sensitization (Part 10): Met requirements.
  • Oral Mucosal Irritation in Hamsters: 14 days (Part 10): Met requirements.
• Test article deemed safe and biocompatible for the intended use. |
  | Manufacturing Process | Verification and validation of manufacturing process | - Verification and validation performed by Prismatik Dentalcraft, Inc.
• Led to acceptable performance for functional attributes and physical finish. |
  | "Clinical" Equivalence | Intended uses are the same as predicate | - "To reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older." - Confirmed as same. |
  | | Mechanisms of action are the same | - "Holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep." - Confirmed as same. The minor difference in how the action is achieved (adjustability mechanism) was addressed by V&V testing. |
  | | Materials for trays are the same as predicate | - "Heat-sensitive impression dual-layer material." - Confirmed as same. |
  | | Manufacturing methods similar | - Confirmed as similar. |
  | | Non-sterile | - Device is non-sterile. - Confirmed as same as predicate. |
  | | Prescription Use Only; Single patient use, removable, reusable | - Confirmed as same. |
  | | Environment of Use: In patient's home or sleep laboratory | - Confirmed as same. |

Study Details Proving Device Meets Acceptance Criteria

2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify discrete sample sizes for the functional and manufacturing verification/validation tests. These types of tests typically involve testing a representative number of units from manufacturing runs.
The data provenance is from Prismatik Dentalcraft, Inc. (the manufacturer), indicating these are internal company tests, likely conducted as part of their quality management system for product development and release. The tests are prospective in the sense that they are performed on newly manufactured devices to confirm design specifications and manufacturing quality.
No specific country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA (USA), implying the testing was conducted under US regulatory considerations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document details engineering and biocompatibility testing, not clinical studies requiring expert ground truth in the diagnostic sense. Therefore, experts in this context would be test engineers, quality control personnel, and lab technicians. Their qualifications are not specified but would be implicit in their roles within the manufacturing and testing environment (e.g., trained in verification/validation, ISO standards, good laboratory practices).

4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical image review or diagnostic agreement. Adjudication would be based on objective criteria defined in the test protocols (e.g., measurement within tolerance, pass/fail result for biocompatibility tests). Deviations would be addressed through standard quality control and engineering procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study was described or required. This is a 510(k) submission for a physical medical device, not an AI/software device that would typically involve human reader performance studies. The substantial equivalence relies on the device's design, materials, and mechanism of action being sufficiently similar to a legally marketed predicate, backed by engineering and biocompatibility testing. The predicate device's clinical effectiveness is already established.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This isn't an algorithm or AI device. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications, material standards (ISO 10993), and functional design requirements. For example, the ground truth for "mandibular advancement function correct" is that the device can reliably achieve the specified 0.25 mm increments up to 10 mm. For biocompatibility, the ground truth is "met requirements of each test" according to ISO 10993.

8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning product that requires a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set is relevant for this type of device.

In summary, this 510(k) submission establishes substantial equivalence for a physical medical device based on engineering verification and validation, biocompatibility testing, and comparison of design and intended use to a predicate device, rather than clinical efficacy trials or AI/software performance studies.

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