Search Results
Found 6 results
510(k) Data Aggregation
(253 days)
Protective Cap
Protective Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.
The Protective Cap is a dental implant superstructure made of PC(Polycarbonate) according to ASTM F997. It is used temporarily, such as less than 10 days before the final restoration is connected. The Protective Cap is supplied nonsterile and intended for single use. It is to be sterilized by end users before use.
This FDA 510(k) premarket notification for the "Protective Cap" device does not involve an AI/ML algorithm. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance evaluation is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the non-clinical testing data provided, which serves as the "study" to meet the "acceptance criteria" for safety and effectiveness in this context:
Non-Clinical Testing Data (Acceptance Criteria & Device Performance):
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Sterilization Validation | End User Sterilization Validation (according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1) | Recommended sterilization validated according to standards. Worst-case construct tested. |
| Biocompatibility | ISO 10993-1:2018 (including ISO 10993-5, ISO 10993-23, ISO 10993-10, ISO 10993-11) | Demonstrates substantial equivalence with the predicate device regarding biological safety. |
| - Cytotoxicity Test | Passed | |
| - Irritation Test (Oral mucosa) | Passed | |
| - Sensitization Test | Passed | |
| - Systemic Toxicity Test | Passed | |
| Cleaning Process Validation | ISO 11737-1:2018, ISO/TS 17665-2: 2009 | Confirmed effective in terms of cleaning effect (Physicochemical tests, cleaning agent residual test, residual on evaporation test, microbial test, drying validation tests performed). Worst-case sample evaluated. |
Explanation for Missing AI/ML-Specific Information:
Since this submission is for a physical medical device (a protective cap for dental implants) and not an AI/ML software device, the following points are not discussed in the document:
- Sample size for test set and data provenance: No test sets of data were used in the AI/ML sense. Physical samples of the device were used for sterilization, biocompatibility, and cleaning validation.
- Number of experts and their qualifications for ground truth: No ground truth establishment by experts for AI/ML performance was required.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. There is no human reader component that would be "augmented" by an AI.
- Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used: For physical device testing, the "ground truth" is adherence to established engineering and medical standards (e.g., successful sterilization, non-toxic, effectively cleaned).
- Sample size for training set: Not applicable, as there is no AI model to train.
- How ground truth for training set was established: Not applicable.
The document concludes that the Protective Cap is substantially equivalent to its predicate device based on these non-clinical tests, sharing the same intended use, material, functions, principle of operation, sterilization method, and similar designs and dimensions, with differences not affecting fundamental function.
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(160 days)
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
The Straumann® Magellan™ abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan™ abutments are indicated for screw-retained restorations.
This proposed Magellan™ Bone Level Abutment System is based upon the currently cleared Regular CrossFit® (RC) and Narrow CrossFit® (NC) screw-retained Bar and Bridge Abutment Line under premarket notification K080239. The Magellan product line includes one-piece straight abutments for the NC interface, straight and angled (17° and 30°) abutments for the RC interface, basal screws, occlusal screws, protective caps and titanium and gold restorative copings.
This submission, K133421 for the Straumann® Magellan™ Abutment System, is a Traditional 510(k) for a dental implant abutment. The review focuses on demonstrating substantial equivalence to predicate devices, rather than establishing clinical efficacy through direct performance testing with acceptance criteria in the typical sense of a diagnostic or therapeutic medical device.
Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate device's design, materials, and performance standards, specifically dynamic fatigue testing for dental implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (based on predicate equivalence and ISO standard) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | ||
| Implant/Abutment Connection | Equivalent to predicate device's CrossFit® connection. | CrossFit® connection with anti-rotation feature. Deemed Equivalent: "Anti-rotation feature not required for bar and bridge constructs." |
| Diameter | Diameters of subject devices to be within the range of the predicate devices (RC: Ø4.0, 4.5, 6.5 mm; NC: Ø3.5, 4.5 mm). | RC: Ø4.6 mm, NC: Ø3.5, 4.6 mm. Deemed Equivalent: "The diameters of the subject devices are within the range of the predicate devices." |
| Gingival Height (GH) | Gingival heights offered to be within the range of the predicate devices (1.0 mm, 2.5 mm, 4.0 mm). | 1.0mm, 2.5 mm, 4.0 mm. Deemed Equivalent: "The gingival heights of the subject devices are within the range of the predicate devices." |
| Abutment Height | Abutment heights offered to be within the range of the predicate devices (1.0 mm, 4.6 mm). | 1.7 mm, 1.9 mm. Deemed Equivalent: "The abutment heights of the subject devices are within the range of the predicate devices." |
| Materials | ||
| Titanium-Aluminum-Niobium Alloy (Ti-6AI-7Nb) | Meeting the requirements of ISO 5832-11. | Manufactured from Ti-6AI-7Nb, meeting ISO 5832-11 requirements. |
| Gold Copings | Made from Ceramicor® alloy. | Made from Ceramicor® alloy. |
| Protective Caps | Made from Polyether Ether Ketone (PEEK). | Produced from PEEK. |
| Performance Testing | ||
| Dynamic Fatigue Performance | Expected to meet the requirements of ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants for abutment connection performance). The acceptance criteria for this standard typically involve testing a statistically significant number of samples to a specified load and number of cycles (e.g., 5,000,000 cycles for fatigue strength) without failure, or demonstrating fatigue strength at a level comparable or superior to the predicate device. | Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. The submission indicates this testing supports the conclusion of substantial equivalence; implicitly, the device met the performance requirements of the standard, thereby being equivalent to or better than the predicate's expected performance, given the lack of specific numerical criteria provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench testing for performance evaluation.
- Sample Size: Not explicitly stated in the provided text for each specific test within ISO 14801. ISO standards typically mandate a minimum number of samples for statistical significance in mechanical testing (e.g., 5-6 samples for each test condition for fatigue testing to determine a fatigue limit).
- Data Provenance: Bench test data, therefore, no country of origin for patient data. It is inherently retrospective in the sense that the testing was completed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relates to a physical medical device (dental abutment) and its mechanical performance, not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by international engineering standards (ISO 14801).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require adjudication for the bench test results. The results are objective measurements of mechanical properties.
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/software device and no human reader studies were conducted.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating device safety and effectiveness in this context is based on established engineering standards (ISO 14801) and equivalence to legally marketed predicate devices. The materials also conform to ISO 5832-11. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in the way it's typically applied to diagnostic or prognostic devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device submission, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or need for ground truth establishment for a training set.
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(90 days)
P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Copings are intended to serve as a base for multi-unit bar or bridge restorations.
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
This 510(k) summary for the Straumann P.004 RC/NC Bar and Bridge Abutment Line does not contain the detailed information necessary to answer your questions about acceptance criteria and study design.
This document is a regulatory submission demonstrating substantial equivalence to previously cleared devices, not a detailed technical report of performance testing against specific acceptance criteria.
Here's why I cannot provide the requested information and what is available in the provided text:
What the document does state:
- Device Description: The Straumann P.004 Dental Implant System, including abutments, copings, and protective caps.
- Intended Use: For supporting prosthetic restorations (crowns, bridges, overdentures) in single or multiple tooth restorations, as bases for bar/bridge constructions, and for temporary restorations or soft tissue protection.
- Technological Characteristics: Claims substantial equivalence to predicate devices in material composition, basic design, and fundamental operating principles.
- Predicate Devices: A list of previously cleared Straumann devices to which equivalence is claimed.
Why the requested information is NOT in the document:
The provided text (a 510(k) summary) focuses on demonstrating "substantial equivalence" to existing, legally marketed devices. For this type of submission, the manufacturer typically highlights:
- Similarities in intended use.
- Similarities in technological characteristics (materials, design, operating principles).
- Performance data (if any significant differences exist or if new performance claims are made) is usually summarized or referenced, but the detailed study methodology, acceptance criteria, ground truth, and reader studies are rarely included in the brief summary itself. These details would be in a more comprehensive technical report or testing documentation (e.g., design control documents, test reports) that is part of the full 510(k) submission, but not typically released publicly in this summary format.
Therefore, I cannot populate the table or provide specific answers for most of your questions based solely on the provided text.
Here is a description of why each requested point cannot be answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not list any specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, dimensional accuracy) or the results from performance studies against such criteria. It generally states that the device has "the same material composition, basic design and fundamental operating principles" as predicate devices, implying performance is equivalent, but without specific metrics.
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Sample size used for the test set and the data provenance:
- Cannot be provided. No specific performance studies with test sets are described. The submission relies on equivalence to predicate devices rather than novel performance data requiring a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. Since no specific test set or performance evaluation study (like a clinical study or even a detailed phantom study) is described in the summary, there's no mention of experts establishing ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. No test set or expert evaluation process is described.
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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 mechanical dental implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Cannot be provided. No ground truth is mentioned because no specific performance study requiring it is described in the summary.
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.
In summary, the provided 510(k) summary is a regulatory declaration of equivalence, not a detailed scientific paper describing performance studies and acceptance criteria. To get the information you're asking for, you would typically need to review the full technical documentation supporting the original 510(k) submission, which is generally not publicly available in this level of detail.
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(32 days)
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
The provided text is a 510(k) summary for dental abutments, temporary copings, and protective caps. It describes a medical device seeking clearance based on substantial equivalence to a predicate device, rather than a study validating its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.
Here is an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the context of a study. The clearance is based on substantial equivalence to a predicate device, meaning the new device is deemed as safe and effective as a legally marketed device without requiring clinical performance data against specific criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No study involving a test set and associated data is described. The clearance is based on the "Technological Characteristics" being substantially equivalent to the predicate device, implying that design, materials, and fundamental operating principles are the same, not on performance data from a specific test set.
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 test set requiring expert-established ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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 document describes mechanical dental components, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance study with a defined ground truth is described. The basis for clearance is "Technological Characteristics" and "intended use" being identical to a predicate device.
8. The sample size for the training set
Not applicable. No dataset (training or otherwise) is mentioned, as this is not a data-driven device clearance.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment is described.
Summary of Device and Clearance Information Provided:
- Device Name: P.004 NC Cementable Abutments, P.004 NC Temporary Copings, P.004 NC Protective Caps
- Common Name: Abutment, Dental, Endosseous implants
- Regulation Number: 21 CFR 872.3630
- Regulatory Class: II
- Product Code: NHA
- Predicate Device: P.004 RC Cementable Abutments, K072071; RC Temporary Copings, K072071; RC Protective Caps, K072071
- Basis for Clearance: Substantial equivalence to the predicate device based on identical intended use, material composition, basic design, and fundamental operating principles.
- Intended Use:
- Abutments: To provide support for prosthetic restorations (crowns, bridges, overdentures) in dental implants.
- Temporary Copings: To serve as a base for temporary restorations for less than 30 days.
- Protective Caps: To protect the outer configuration of the abutment and maintain/condition soft tissue during healing for up to 6 months.
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(16 days)
STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surqical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
This document, K072071, is a 510(k) premarket notification for dental abutments, temporary copings, and protective caps. It claims substantial equivalence to previously marketed devices. Crucially, this submission does not describe a study involving device performance against acceptance criteria in the context of an AI/software device or a comparative effectiveness study involving human readers.
The document details the regulatory classification, intended use, and substantial equivalence to predicate devices (physical dental components). It confirms that the new devices have the same material composition, basic design, and fundamental operating principles as the cleared predicate devices.
Therefore, I cannot extract the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies because this is not a study about an AI/software device.
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(14 days)
SPI EASY DENTAL IMPLANT PROTECTIVE CAP
The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
The Thommen SPI® EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated.
The Protective Cap will be offered in sizes to fitall SPI® EASY abutments and may be used with all SPI® System dental implants.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) premarket notification for a dental implant component, focusing on its substantial equivalence to a predicate device. It details administrative information, device description, intended use, and equivalence to a marketed product, but it does not include any performance metrics, study designs, or acceptance criteria relevant to the questions asked.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies.
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