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510(k) Data Aggregation
(269 days)
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(100 days)
The NOBILCAM IMPAK Disc is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, nightguards, bruxism appliances and other devices as prescribed.
The NOBILCAM IMPAK Disc contains a cured disc, to be used in a CAD/CAM machine to produce an occlusal splint for suffering patients. NOBILCAM IMPAK Disc is mainly composed of acrylic resin and manufactured through compression molding. Depending on the different CAD/CAM machines used for the product, NOBILCAM IMPAK Disc is designed into various specifications and shades to meet different needs.
I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for an AI/CADe device.
The document describes the regulatory clearance for a dental material device called "NOBILCAM IMPAK Disc", which is an acrylic compound used for fabricating dental appliances.
It focuses on:
- Physical and Chemical Properties Tests: These are bench tests comparing the material properties (e.g., appearance, dimension, color stability, water sorption, hardness, flexural strength) of the subject device to a predicate device and relevant ISO/ADA standards.
- Biocompatibility Tests: These are biological safety tests performed according to ISO 7405 and ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
- Technological Characteristics Comparison: A table comparing ingredients, physical form, indications for use, sterility, storage conditions, and packaging with predicate and reference devices.
There is no mention of:
- An AI or CADe device.
- Any diagnostic or detection performance metrics (e.g., sensitivity, specificity, AUC).
- Human reader studies or multi-reader multi-case (MRMC) comparative effectiveness studies.
- Ground truth established by experts or pathology.
- Sample sizes for training or test sets for an algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on this document, as the document pertains to a physical dental material, not an AI software or diagnostic device that would typically have the performance metrics and study types you've listed.
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(277 days)
Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.
Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.
The provided text describes a 510(k) premarket notification for two light-curable resins, "Hard Splint" and "Thermo-Adaptive Splint," for fabricating dental appliances. It mainly focuses on the substantial equivalence to predicate devices based on technological characteristics and non-clinical tests. However, it does not contain information related to software performance, AI algorithms, human-in-the-loop studies, or the acceptance criteria for such systems.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or software, nor can I answer questions about sample sizes for test sets, data provenance, expert-established ground truths, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This document pertains to the material properties and biocompatibility of the resins, not the performance of a diagnostic or analytical device with acceptance criteria involving sensitivity, specificity, or other performance metrics typically associated with AI.
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(89 days)
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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(100 days)
The LIJIA Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
The LIJIA 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 the LIJIA Night Guard. It states that no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the device due to similarities in indications for use, technological characteristics, and non-clinical performance testing validated against a predicate device.
Therefore, there is no information available in the provided text about acceptance criteria for device performance, the study that would prove the device meets these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or sample sizes for training sets.
The document focuses on the substantial equivalence determination for the LIJIA Night Guard based on non-clinical performance testing and comparison to predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria.
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(419 days)
The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.
The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems
The provided text describes a 510(k) premarket notification for a GR Resin System MSI, a light-curable polymerizable resin used for fabricating orthodontic and dental objects. However, it does not contain information about a study proving the device meets acceptance criteria related to artificial intelligence (AI) performance, human reader improvement with AI assistance (MRMC), or standalone algorithm performance.
This document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, chemical composition, manufacturing technology, physical state, curing method, and compliance with performance, biocompatibility, and shelf-life standards. The "Performance Testing" section only states that testing was performed in accordance with ISO 20795-2 for Flexural Strength, Flexural modulus / Bending module, Water Sorption, and Solubility.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/human-in-the-loop device, as the provided text pertains to a different type of medical device (a dental resin).
To answer your request, I would need a document describing the study and acceptance criteria for an AI-powered medical device.
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(85 days)
Thermoforming Sheet Materials Track A, B, E and Bleach are indication of orthodontic and dental appliances.
Thermoforming Sheet Materials are pre-shaped flat plastic discs. The sheets are plastified in appropriate thermoforming units and adapted onto patient individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. Thermoforming Sheet Materials include the following products: Thermoforming Sheet Materials: Track A, Track B, Track E, Track bleach.
The provided text is a 510(k) summary for Thermoforming Sheet Materials. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for device performance in the context of an AI/algorithm-based medical device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not available in the provided document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for device performance that would typically be associated with an AI/algorithm. Instead, it demonstrates compliance with international standards for biocompatibility and provides a list of physical properties that were tested according to other ISO standards.
| Acceptance Criteria (Not explicitly stated as such for performance, but as compliance to standards) | Reported Device Performance (Summary of compliance) |
|---|---|
| Biocompatibility (according to EN ISO 10993-1 and FDA Guidance) | The insolubility of the Thermoforming Sheet Materials is in compliance with EN ISO 10993-1 and the FDA Biocompatibility Guidance Document for the intended dental use. |
| Physical Properties (according to various ISO standards as listed) | "Physical properties have been tested according to the applicable standards." (No specific values reported in this summary). |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This device is a material, not an AI/algorithm that uses a test set of data. The testing mentioned in the document relates to material characterization.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth is a concept related to labeling data for AI/algorithm development and evaluation. This document describes physical material testing.
4. Adjudication Method:
Not applicable. This is relevant for establishing ground truth in AI/algorithm studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses human performance with and without AI assistance, which is not relevant for a material-based device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is not an algorithm.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" here would be the physical properties and biocompatibility of the material itself, determined through standard laboratory tests, not expert consensus or pathology on a dataset.
8. Sample Size for the Training Set:
Not applicable. This device is a material, not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary from the provided document:
The provided document details a 510(k) premarket notification for Thermoforming Sheet Materials. The focus is on demonstrating substantial equivalence to an existing predicate device (K200125 from Erkodent Erich Kopp GmbH). The core of the justification is that the proposed device, the Thermoforming Sheet Materials, are similar in:
- Indications for Use: Fabrication of orthodontic and dental appliances.
- Material: Resin / Thermoplastic.
- Fabrication Method: Thermo-Molding Custom-Fit.
- Prescription Device: Yes.
- Re-Usable Device: Yes, single consumer/patient.
- Sterility: Non-Sterile.
- Biocompatibility: Yes.
Non-Clinical Testing: The document states that non-clinical testing was performed for biocompatibility according to EN ISO 10993-1 and FDA Guidance, and physical properties according to various ISO standards. The results demonstrated compliance for biocompatibility. Specific numerical values for the physical properties were not provided in this summary.
Clinical Testing: No clinical testing was performed in support of this submission.
In conclusion, the document does not contain the type of acceptance criteria and study information typically found for AI/algorithm-based medical devices. It is a regulatory submission for a physical material, demonstrating equivalence to a lawfully marketed predicate.
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(109 days)
The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.
The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The provided document does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets such criteria.
The document is a 510(k) premarket notification for the Slow Wave DS8 device, which is an intraoral appliance indicated for the treatment of sleep bruxism and associated tension/migraine type headaches. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies.
The document explicitly states in section 1.8.1 "Clinical Studies": "Clinical testing was not necessary for the demonstration of substantial equivalence." This means there was no study conducted to measure and report device performance against acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on comparing the Slow Wave DS8 to a predicate device (Luco Hybrid OSA Appliance K160477) and reference devices (Formlabs Dental LT Clear V2 K222061 and Slow Wave DS8 K191320) based on characteristics like classification, product code, indications for use, prescription status, target population, use of device, principle of operation, features, material properties, materials, manufacturing method, and sterility. The "Performance Data" section (1.8) only states that "Performance requirements were determined through an assessment of the physical properties of the device," implying engineering or material testing, not clinical performance data against specific acceptance criteria relevant to the device's therapeutic claims.
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(280 days)
RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material, RODIN 3D Resin SPLINT, Hard/Flex. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML powered device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.
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(218 days)
Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.
Dental LT Comfort Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances, such as occlusal splints, nightguards, mouthguards and repositioners by additive manufacturing.
The provided text describes the submission and clearance of "Formlabs Dental LT Comfort Resin" by the FDA. It is not an AI/ML medical device submission, it is a statement of substantial equivalence for a new dental resin product to existing predicate devices. Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML medical device is not present in the provided text.
The document details the following regarding the Dental LT Comfort Resin:
- Indications for Use: To print dental or orthodontic appliances to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism.
- Predicate Devices: Dental LT Clear V2 Resin (K222061) and KeySplint Soft (K183598).
- Technological Characteristics: Light-curable polymer-based resin for additive manufacturing (3D printing) of dental appliances, followed by post-processing (washing, curing, sanding, polishing, disinfecting).
- Performance Data:
- Biocompatibility Testing: Evaluated according to ISO 10993-1:2018 and ISO 7405:2018. Results indicated biocompatibility for long-term (>30 days) mucosal membrane contact.
- Performance Attributes: Tested according to ISO 20795-2, ASTM D 638-14, and ASTM D 2240-15. The results "meet passing criteria or fall between the two predicate devices."
Key takeaway: The document does not describe an AI/ML algorithm or its performance criteria, but rather the material properties and biocompatibility of a dental resin intended for 3D printing. Therefore, it is impossible to answer the questions about AI/ML device acceptance criteria and study details based on the provided text.
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