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510(k) Data Aggregation
(247 days)
Panthera Dental Milled Bars
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.
| Acceptance Criteria Category | Description of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Meets the requirements for dynamic fatigue testing for endosseous dental implants. | The device (bar and cylinders) has the mechanical strength for its intended clinical application, as demonstrated by fatigue testing according to ISO 14801 and FDA guidance. |
| Biocompatibility | Biocompatible with tissue/bone/dentin for long-term contact. | Made from Titanium Ti-6Al-4V, a material used in the predicate. Cytotoxicity, extractable/leachable, toxicological risk assessment, and bacterial endotoxin testing compliant with ISO 10993-1, ISO 10993-5, ISO 10993-12, ANSI/AAMI ST72, and USP . |
| Sterilization | Can be effectively sterilized to a Sterility Assurance Level (SAL) of 10^-6. | Sterilization validation (Pre-vacuum steam sterilization) for the primary predicate was successful, demonstrating an SAL of at least 10^-6. The proposed device uses the same materials and sterilization cycle, therefore no additional testing was required. |
| Design Accuracy/Fit | Ensures a perfect fit and proper seating with compatible implant systems, with no possible interference. | Reverse engineering (RE) confirmed that the critical parameters of the design for interface connection, including tolerance limits, fall within the measured sizes of the Nobel Biocare counterparts. |
| Manufacturing Reliability | Manufacturing process is reliable and produces consistent results. | A process capability study conducted for the primary predicate (K173466) is valid for the proposed device, as the manufacturing process is identical. |
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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(181 days)
Panthera Dental Milled Bars
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:
- 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.
- 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.
- 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.
- Adjudication method for the test set: Not applicable.
- 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.
- 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.
- 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).
- The sample size for the training set: Not applicable. There is no AI/algorithm training set.
- 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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(79 days)
Panthera Dental Milled Bars
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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