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The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.

The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.

The provided text describes the 510(k) premarket notification for the Panthera Occlusal Appliance. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving the performance of a novel AI/software-driven medical device against specific acceptance criteria using a study.

Therefore, the information required to answer the prompt regarding AI/software performance, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided document.

The document states:

• "Human clinical study was not deemed necessary to support substantial equivalence." (page 7)
• "The Panthera Occlusal Appliance does not use design dissimilar from the primary predicate and reference devices, does not use new technologies different from the primary predicate and reference devices, and does not deviate from the indications for use of the primary predicate and reference devices." (page 7)

This indicates that the submission relies on demonstrating that the new device is fundamentally similar in design, technology, and indications for use to existing, legally marketed devices (predicates and references). The "bench testing" mentioned (page 7) is for physical properties and intended use, not for AI/algorithm performance.

In summary, the provided document does not contain the information requested in the prompt, as it is a 510(k) for a physical dental appliance based on substantial equivalence, not an AI/software medical device requiring performance studies against specific acceptance criteria.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with:

• · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
• NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
• NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
• NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
• Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0

The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.

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

• Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
• Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.

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

• Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
• Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
• Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
• Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.

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

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with:

• Standard/Standard Plus RN Ø 4.1/4.8 (platform Ø 4.8)
• Standard/ Standard Plus/Tapered Effect WN Ø 4.8 (platform Ø 6.5)
• Tapered Effect RN Ø 4.1 (platform Ø 4.8)
• Bone Level/ Bone Level Tapered NC Ø 3.3 (platform Ø 3.3)
• Bone Level/ Bone Level Tapered RC Ø 4.1, 4.8 (platforms Ø 4.1 and 4.8)

The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual. Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

This document, a 510(k) Premarket Notification for the Panthera Dental Milled Bars, describes the device and its claimed substantial equivalence to a predicate device. However, it does not contain information about a study that measures the device's performance against specific acceptance criteria for AI/algorithm-based medical devices.

The provided text focuses on the device's design, materials, manufacturing process, and non-clinical testing (sterilization, biocompatibility, FEA, fatigue testing, reverse engineering, process capability) to demonstrate its mechanical and physical properties. It explicitly states that "Panthera Dental Inc. did not performed clinical testing" and "Human clinical study was not deemed necessary to support substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and performance data for an AI/algorithm-based medical device, as this document pertains to a physical dental device and does not involve AI or an algorithm requiring such a study.

To directly answer your specific points based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes non-clinical engineering and material tests, not performance metrics of an AI/algorithm.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/algorithm study. The non-clinical tests involved physical samples of the dental bars (e.g., for fatigue testing, sterilization validation). Data provenance relates to the testing conducted by Panthera Dental Inc. in Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/algorithm performance is irrelevant for this physical device.
4. Adjudication method for the test set: Not applicable.
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. The document explicitly states no clinical testing was performed, and this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical dental device, not an algorithm.
7. The type of ground truth used: Not applicable for an AI/algorithm. For the physical device, "ground truth" would relate to engineering specifications and material properties, validated through established standards (e.g., ISO 14801 for fatigue testing, USP for sterility).
8. The sample size for the training set: Not applicable. There is no AI/algorithm training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device and does not involve the type of AI/algorithm performance studies you are inquiring about.

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The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharvngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The maximum protrusion of the device is 5 mm in 1 mm increments.

This document is a 510(k) premarket notification for the Panthera Anti-Snoring X3 Device, seeking substantial equivalence to previously marketed devices. The document explicitly states that no human clinical study was deemed necessary to support substantial equivalence (page 12), and therefore, a study proving the device meets acceptance criteria based on human clinical data is not provided in this submission.

The acceptance criteria and device performance are instead established through non-clinical testing, primarily by demonstrating equivalence to a primary predicate device (The Panthera Anti-Snoring Device, K143244) and several reference predicate devices.

Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "reported device performance" against clinical acceptance criteria is not applicable. Instead, the non-clinical testing focused on establishing substantial equivalence based on material properties, design, and mechanical strength.

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

• Sample size: Not applicable for a clinical test set as no clinical study was performed. For non-clinical testing, specific sample sizes for material and fatigue tests are not provided in this summary but would have been part of the underlying test reports.
• Data provenance: Not applicable in terms of country of origin or retrospective/prospective for a clinical study. The non-clinical testing was conducted by Panthera Dental Inc.

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

Not applicable. As no human clinical study was performed, there was no ground truth established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No human clinical study was performed with a test set 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

Not applicable. This device is a physical intraoral device, not an AI or imaging diagnostic tool, and no MRMC study was performed.

6. 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.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by industry standards (e.g., ASTM D638, NISTIR 8059) and regulatory biocompatibility standards (e.g., ISO 14971, ISO 10993). Equivalence to predicate devices with established safety and effectiveness also serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set was involved.

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

Not applicable. No machine learning algorithm or training set was involved.

Summary of the Study (Non-Clinical Evidence for Substantial Equivalence):

The Panthera Anti-Snoring X3 Device's substantial equivalence was established through non-clinical testing and comparison to legally marketed predicate devices rather than a human clinical study.

• Non-Clinical Testing:

  • Material Equivalence: The device uses the same raw material (polyamide type 12), supplied by EOS, and the same proprietary manufacturing process (Selective Laser Sintering) as its primary predicate, The Panthera Anti-Snoring Device (K143244). This allowed for leveraging performance testing (orthosis polishing, static and dynamic compression resistance) from the predicate's submission.
  • Mechanical Testing: A specific test was conducted to determine build locations for 3-D printing in accordance with FDA guidance and standards (ASTM D638, NISTIR 8059).
  • Fatigue Testing: Because the mechanism for mandibular protrusion differed from the primary predicate (stop-clip system assembly vs. interlocking rods), dedicated fatigue testing was performed on the stop-clip system assembly. The results demonstrated sufficient mechanical strength for its intended clinical application.
  • Biocompatibility: Assessed and confirmed to be biocompatible based on the use of identical materials, supplier, and manufacturing process as the primary predicate device, following ISO standards (14971, 10993-1, 10993-5, 10993-10).

• Rationale for No Clinical Study: The FDA submission states that a human clinical study was "not deemed necessary" because the Panthera AS X3:

  • Does not use a design dissimilar from the reference predicate devices.
  • Does not use new technologies different from the primary and reference predicate devices.
  • Does not deviate from the indications for use identified in the primary and reference predicate devices.

In essence, the "study" proving the device meets its "acceptance criteria" here is a comprehensive non-clinical assessment demonstrating that the device is materially, technologically, and functionally equivalent or superior in specific mechanical aspects to its established predicate devices, which already have demonstrated safety and effectiveness through their own market history or prior submissions.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.

The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement.

The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

The provided text is a 510(k) summary for a medical device (Panthera Dental Milled Bars), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for an AI/CADe device.

Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/CADe device.

Here's why and what kind of information would be needed:

• Acceptance Criteria & Reported Device Performance: This document only provides a comparison of design specifications between the applicant's device and a predicate device (Tables 5.1, 5.2, 5.3) for physical dimensions and material. It does not list "acceptance criteria" in the way one would for an AI/CADe system (e.g., sensitivity, specificity, AUC thresholds).
• Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "Human clinical study was not deemed necessary to support substantial equivalence." and "Panthera Dental Inc. performed no clinical testing." It discusses non-clinical testing like fatigue testing, biocompatibility, and process capability for the physical dental bar, not an AI algorithm.
• Missing Information for AI/CADe devices: The document lacks all the specific details you requested for an AI/CADe study, such as:
  • Sample sizes for test sets (it mentions "thirty (30) cylinders" for process capability testing, not an AI test set).
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone algorithm performance.
  • Type of ground truth (pathology, outcomes data, etc.).
  • Training set sample size and ground truth establishment for the training set.

In summary, the provided document describes a physical dental device, not an AI/CADe system, and thus does not contain the information requested about AI performance metrics or related studies.

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The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the dentist. The maximum protrusion of the device is 15 mm in 1 mm increments.

This document is a 510(k) premarket notification for "The Panthera Anti-Snoring Device." It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device, the Narval CC.

Based on the provided text, the device itself is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies (like training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not applicable.

Here's the information extracted and formatted as requested, with explanations for non-applicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device seeking substantial equivalence, the "acceptance criteria" are generally based on physical and material properties, and the "reported device performance" is a comparison to the predicate. The document doesn't explicitly state numerical acceptance criteria in the way one would for an AI algorithm's performance metrics. Instead, it focuses on demonstrating equivalence in design, materials, and intended use.

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

This device is not an AI/ML algorithm, and no clinical "test set" in the context of algorithm evaluation was used. The submission states, "Panthera dental performed no clinical testing." The demonstration of safety and effectiveness relies on non-clinical testing (physical properties, biocompatibility) and comparison to a legally marketed predicate device.

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. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission for a physical device.

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

Not applicable. No test set requiring expert adjudication was used.

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

Not applicable. This is not an AI/ML device and no MRMC study was conducted.

6. 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.

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

Not applicable. "Ground truth" in the context of AI/ML evaluation is not relevant for this physical device submission. The safety and effectiveness are established through material characterization, design specifications, and comparison to the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. This is not an AI/ML algorithm.

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