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ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.

The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.

This looks like a 510(k) premarket notification for a dental implant system. Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The application states that the new device, the ANKYLOS® C/X Implant 6.6 mm, is a line extension of an already cleared device and has largely similar characteristics to its predicate device (K083805 - ANKYLOS® C/X Dental Implant System). The primary acceptance criteria for this type of submission are typically demonstrating substantial equivalence to a legally marketed predicate device, especially in terms of safety and effectiveness.

Here's a table based on the provided "Similarities and Differences" section and the described non-clinical performance data to outline the criteria and the device's performance against them:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many implants were used for fatigue testing or CAD analysis. It simply states "Fatigue testing was conducted on the subject ANKYLOS® C/X Implant 6.6 mm in comparison to the predicate device" and "surface area and bone to implant contact have been calculated by CAD data for the ANKYLOS® C/X Implant 6.6 mm and the predicate device, respectively." For a 510(k) submission, especially for a line extension, the focus is often on representative samples demonstrating conformance to standards rather than large statistical cohorts typical of clinical trials.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of mechanical testing (fatigue, CAD), it's highly likely this was laboratory-based, prospective testing rather than clinical data.

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 type of submission focuses on non-clinical performance (mechanical testing and CAD analysis). Therefore, no external experts or clinicians were explicitly used to establish ground truth for a "test set" in the way one might for a diagnostic AI device. The ground truth is established by an international standard (ISO 14801) for fatigue testing and engineering principles for CAD analysis, performed by the manufacturer's qualified personnel.

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

• None. As explained above, this is a non-clinical, engineering-focused evaluation based on established standards and calculations rather than subjective assessment 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

• No. This device is a dental implant, which is a physical medical device, not a diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

• No. This is a physical dental implant, not an algorithm or AI system.

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

• The ground truth for the non-clinical performance data (fatigue, surface area, bone-to-implant contact) is derived from engineering standards (ISO 14801) and CAD calculations based on the device's design specifications for the implant and comparison to the predicate. The "ground truth" for the FMEA is based on risk analysis methodologies.

8. The sample size for the training set

• Not applicable. This device is a physical dental implant. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles, material science, and testing, not through training data in the AI sense.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for one. The "truth" about the device's functionality is established through its design, material properties, and adherence to performance standards.

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The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:

• . Stain removal,
• Prophylaxis of orthodontic patients, .
• Preparing tooth surfaces prior to bonding and sealant procedures, and ●
• Implant debridement .

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.

Here's a breakdown of the acceptance criteria and study information for the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical trial data. Therefore, many of the requested elements (especially those related to human reader studies, specific ground truth establishment for a test set, and detailed statistical results) are not available in this type of document. The study described here is primarily non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the compliance with regulations and successful performance in the specified tests, which aim to ensure the device is safe and effective and substantially equivalent to predicate devices. The reported device performance is that it met these criteria.

Study Details

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

• Sample Size (Test Set): Not explicitly stated for each test (e.g., number of samples for stain removal or abrasion tests). The document refers to "internal specification and testing" and "third-party testing" for these aspects. For electrical and software compliance, the "sample" is typically the device itself or its software.
• Data Provenance: The tests include "Internal specification and testing" and "third-party testing." The country of origin for the data is not specified, but the applicant is DENTSPLY International, located in York, PA, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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

• This information is not provided in the document. For non-clinical performance tests like stain removal and abrasion, ground truth might be established through standardized methods, quantitative measurements, or comparison to established benchmarks, rather than expert consensus on a test set in the way it might be for an imaging AI device.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. This type of detail is typically relevant for human review of data, such as in clinical imaging studies. For the described non-clinical performance tests, adjudication methods are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document explicitly states: "No human clinical data has been provided to support substantial equivalence." Therefore, an MRMC study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• Not applicable in the AI sense. The device is a physical instrument, not an AI algorithm. The performance evaluation focuses on the device's physical capabilities (stain removal, abrasion, electrical safety, etc.) and software functionality as an integrated system, which is inherently "standalone" in its operation relative to human decision-making. No "algorithm only" performance would be separately evaluated in this context.

7. The Type of Ground Truth Used:

• Standardized Test Methods/Quantitative Measurements/Predicate Device Comparison: For non-clinical tests, ground truth is established by standardized testing protocols (e.g., for electrical safety, EMC), internal specifications, and performance against accepted benchmarks (e.g., stain removal effectiveness compared to industry standards or predicate device performance, enamel abrasion within acceptable limits). The core of this submission is showing substantial equivalence to predicate devices, implying their existing performance provides a "ground truth" for acceptable levels.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering design, prototyping, and iterative testing, not data-driven model training.

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

• Not applicable. As above, there's no "training set" in the context of an AI algorithm. The design and development process for a physical medical device relies on engineering principles, material science, previous device knowledge (predicates), and internal testing to ensure it meets its intended specifications and safety standards.

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QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.

QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the QMix™ 2in1 Endodontic Irrigating Solution:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is a "Cleanser, Root Canal" and its indication for use is to "cleanse and disinfect the root canal system after endodontic instrumentation." The core of the submission relies on demonstrating substantial equivalence to a predicate device.

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

• Sample Size: Not applicable. No clinical studies were conducted, meaning no test set of patient data was used.
• Data Provenance: Not applicable. The studies mentioned are non-clinical (in vitro and ex vivo).

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

• Number of Experts: Not applicable. No clinical studies were performed requiring expert ground truth establishment for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical studies with a test set were conducted.

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

• MRMC Study: No. The document explicitly states: "No clinical studies were conducted on this device." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
• Effect Size: Not applicable.

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

• Standalone Study: Yes, in a sense, but not for an "algorithm" in the context of an AI device. The efficacy of the chemical solution itself was demonstrated through non-clinical in vitro and ex vivo studies. These studies evaluate the direct performance of the device (the irrigating solution) without human interpretation of images or data in a diagnostic context.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical in vitro and ex vivo studies, the "ground truth" would be established by scientific methods appropriate for laboratory assays, such as:
  • Microbiological assays: To quantify bacteria killing.
  • Electron microscopy or other imaging techniques: To assess smear layer removal.
  • Chemical analysis: To confirm component presence, stability, and reaction kinetics.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a chemical solution, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data used to train an AI model.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.

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Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.

The provided text is a 510(k) summary for the "Pre-Cemented Orthodontic Bracket System Extension II". It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Based on the information provided, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

• Prior use of components in legally marketed devices.
• Performance data provided (though specific metrics are not detailed in this summary).
• Previous biocompatibility data.
• The claim that shear bond strength testing, Failure Mode Effect Analysis (FMEA), and biocompatibility testing were not necessary due to no change in the super mesh base from predicate devices. |
  | Substantial Equivalence | The device is deemed substantially equivalent to the predicate devices:
• DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System (K061252)
• DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System Extension (K081291) |
  | Technological Characteristics | The device represents an addition to K081291, and all its components have been used in legally marketed devices or found safe for dental use. No change in the super mesh base for metal and ceramic brackets. |

Study Information

1. Sample size used for the test set and the data provenance:
   The provided 510(k) summary does not detail any specific clinical or performance study with a test set. It relies on the substantial equivalence to predicate devices and the prior use of components. It states that "performance data provided" but does not specify what this data entails or for which tests it was collected. Therefore, information regarding sample size, country of origin, or whether it was retrospective/prospective is not available.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. No specific "test set" requiring ground truth established by experts is described in this summary. The submission is based on substantial equivalence and component history rather than a new performance study requiring expert adjudication of a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. As no specific "test set" is detailed, no adjudication method is mentioned.

4. 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 a physical orthodontic bracket system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not explicitly detailed. The "ground truth" for the device's safety and effectiveness appears to be derived from the established safety and performance of its predicate devices and the historical use of its components. There is no mention of specific new ground truth generation through e.g., pathology or new outcomes data specific to this device extension. The statement "performance data provided" is vague.

7. The sample size for the training set:
   Not applicable. As this is a physical device and not an AI/machine learning algorithm, there is no concept of a "training set."

8. How the ground truth for the training set was established:
   Not applicable. As there is no training set mentioned, this question is not relevant.

In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to previously cleared devices. It does not present new, extensive clinical study data or a detailed performance study with a separate test set, training set, or expert adjudication as would be seen for a novel diagnostic device or AI algorithm.

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The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.

The provided text describes a 510(k) summary for the ANKYLOS® C/X Dental Implant System, focusing on its substantial equivalence to predicate devices. However, the document does not contain the detailed study information typically associated with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations as requested in the prompt.

The document states:

• "The results regarding the fatigue tests of the ANKYLOS® C/X Implant and the predicate devices were comparable. Therefore, it concluded that the ANKYLOS® C/X Implant performs as intended."

This is the only mention of performance data. It refers to a "fatigue test" and a "comparable" result. This does not provide specific acceptance criteria, numerical performance metrics, or details about the study design beyond stating "fatigue tests."

Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Cannot be determined from the provided text. The text only mentions "fatigue tests" without any details on the number of devices tested or the origin of the data.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Cannot be determined from the provided text. This type of information is not present. The evaluation focuses on non-clinical performance (fatigue tests), not expert interpretation.

4. Adjudication method for the test set:

• Cannot be determined from the provided text. This is not relevant for the type of non-clinical testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. An MRMC study was not done. The document describes a non-clinical performance evaluation (fatigue tests) of a dental implant system.

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

• N/A. This question is typically relevant for AI/software devices. The device is a physical dental implant system, so "standalone" performance in this context would refer to its physical function, which was assessed via "fatigue tests."

7. The type of ground truth used:

• For the "fatigue tests," the "ground truth" would be the engineering standards for fatigue life or fracture resistance of dental implants. However, the specific standards or methods for establishing this "ground truth" are not detailed beyond the mention of "fatigue tests."

8. The sample size for the training set:

• N/A. This question is typically relevant for AI/machine learning models. The device is a physical dental implant system and would not have a "training set" in this context.

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

• N/A. (See point 8)

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DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.

DURASHIELD® PLUS is a topically applied, flavored cavity varnish containing sodium fluoride and NovaMin. The varnish is a viscous liquid and is insoluble in water and saliva. NovaMin is a bio-available calcium phosphosilicate that releases calcium and phosphorous when exposed to moisture.

The provided text (K082198) is a 510(k) premarket notification for a dental product called DURASHIELD® PLUS. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specified acceptance criteria and performance data.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The submission primarily discusses:

• Device Name: DURASHIELD® PLUS
• Predicate Device: Sci-Pharm DFV Varnish
• Description: A topically applied, flavored cavity varnish containing sodium fluoride and NovaMin.
• Intended Use: Relief of dental hypersensitivity where dentin and cementum are exposed.
• Technological Characteristics: Similar to predicate device, with the addition of NovaMin for remineralization.
• Non-Clinical Performance Data: Components of DURASHIELD® PLUS passed biocompatibility testing; no additional biocompatibility tests were conducted for the final product.
• Conclusion: Substantially equivalent to the predicate device.

For medical devices, particularly those seeking 510(k) clearance, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not necessarily on meeting specific performance metrics from a de novo study. The FDA's letter confirms substantial equivalence, allowing the device to be marketed.

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The Axis System is an air-powered dental handpiece system indicated for use in general dentistry.

The Axis System consists of air-powered dental handpieces with an electronic accessory to limit the speed.

This 510(k) summary for the Axis System, a dental handpiece, does not contain the detailed information necessary to answer your request about acceptance criteria and study results.

Here's why:

• Device Type: The Axis System is a dental handpiece, which is a mechanical device. The concept of "acceptance criteria" and "device performance" in the context of an AI/software device (which your questions are geared towards, e.g., sensitivity, specificity, ground truth, MRMC studies) is not directly applicable to this type of medical device.
• Information Provided: The summary focuses on established safety and effectiveness through the prior use of its components and existing predicate devices (Rapidd Highspeed Dental Handpiece and eStylus Electric Motor System). It states, "All of the components found in the Axis System have been used in legally marketed devices and/or were found safe for dental use." It also mentions "performance data provided" and "biocompatibility information provided," but the specifics of what that performance data entails or what the acceptance criteria were for a mechanical device are not detailed within this summary.
• Regulatory Pathway: This is a Class I device (Dental Handpiece and Accessories), which generally has a less stringent regulatory pathway compared to devices that diagnose or interpret medical images using AI. The 510(k) process for such a device primarily establishes substantial equivalence to a predicate device, focusing on similar indications for use and technological characteristics rather than requiring extensive clinical performance studies to meet AI-specific metrics.

Therefore, I cannot provide the requested table or elaborations on AI-specific study details because the provided document does not contain information relevant to an AI/software-as-a-medical-device (SaMD) product.

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Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.

The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.

The provided K073117 document is a 510(k) summary for a "DENTIN DESENSITIZER AGENT." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria using a test set, ground truth, or expert review in the way that would typically be described for a diagnostic AI or imaging device.

Therefore, I cannot populate the requested table and detailed study information as the document does not provide this type of data.

Here's why and what information is present:

• Type of Device: The DENTIN DESENSITIZER AGENT is a chemical agent for treating tooth sensitivity, not a software algorithm, an AI device, or an imaging modality.
• Approval Pathway: This is a 510(k) submission, which means the device is being approved based on "substantial equivalence" to legally marketed predicate devices, not necessarily on demonstrating new performance metrics against a defined acceptance criterion via a clinical study with a control group and robust statistical analysis for novel claims.
• Focus of the Submission: The submission highlights:
  • Components: All components have been used in legally marketed devices or found safe for dental use.
  • Biocompatibility Testing: The device passed agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity tests. This demonstrates safety, but not clinical effectiveness in terms of reducing sensitivity in a quantifiable manner against specific criteria.
  • Predicate Devices: The device is compared to Gluma Desensitizer (K962812) and Quell Desensitizer (K010957). The implication is that since these predicates are accepted for treating dentinal hypersensitivity, and the new device shares similar characteristics and has passed safety tests, it is also safe and effective for the same indication.

Conclusion:

Based on the provided text, there is no information to fill in the requested table and answer questions 1-9 regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, ground truth, adjudication methods, or MRMC studies. These details are typically found in submissions for devices that make novel performance claims or rely on AI/software for diagnostic or interpretive functions, which is not the case for this chemical desensitizer.

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MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.

MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose of making various dental and/or orthodontic appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges. Each material is indicated for the fabrication of orthodontic and dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the sheets are thermoformed and trimmed to create custom devices or appliances.

The provided text is a 510(k) summary for "MOUTHGUARD AND ALIGNER MATERIALS." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics of the materials.

It does NOT contain information about specific acceptance criteria related to device performance metrics (e.g., sensitivity, specificity, accuracy), nor does it describe any study involving human readers, ground truth establishment, or sample sizes for testing or training sets.

The summary states: "We believe that the prior use of the components in legally marketed devices and the data provided support the safety and effectiveness of MOUTHGUARD AND ALIGNER MATERIALS for the indicated uses." This indicates that the safety and effectiveness were supported by relying on the known properties of the materials and their previous use in other legally marketed devices, rather than a clinical performance study of the materials themselves against a set of predefined acceptance criteria in the manner requested.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness studies based on the provided text.

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