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The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration. The temporary coping fits over the Straumann solid abulments and has radial projections that facilitate the retention of added acrylic or composite materials to form a temporary restoration.

The provided text is a 510(k) summary for a medical device (Straumann Temporary Coping) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The FDA 510(k) process for this type of device (Straumann Temporary Coping, classified as an accessory to a dental implant abutment, NHA) primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a performance study against those criteria in the same way one might for a novel diagnostic AI algorithm.

Therefore, I cannot fulfill your request for the specific points, as the provided text does not contain the necessary information. The document focuses on:

• Device Description: What the Straumann Temporary Coping is and its intended use.
• Predicate Devices: Identifying similar devices already on the market.
• Basis for Substantial Equivalence: Arguing that the new device is similar in design and intended use to the predicate devices.
• Regulatory Clearance: The FDA's letter granting clearance based on substantial equivalence.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This is because the Straumann Temporary Coping is a physical dental accessory, not a software-based diagnostic device where such performance metrics and studies would typically be required for a 510(k) submission. For physical devices, particularly those claiming substantial equivalence, the focus is often on material biocompatibility, mechanical properties (if relevant), and functional similarity to predicates, rather than statistical performance against expert-derived ground truth on image data.

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Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. Straumann Granules provide a bone void filler that is resorbed and replaced with bone during the healing process.

The provided text is a 510(k) summary for the Straumann Granules, a synthetic bone graft substitute. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics.

Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" cannot be directly filled from this type of regulatory submission. The primary method of demonstrating acceptance for this device is based on substantial equivalence to already legally marketed devices.

Here's an analysis based on the provided text, highlighting what is available and what is not:

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

This information is not explicitly present in the 510(k) summary. For devices like bone graft substitutes seeking clearance via the 510(k) pathway, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to predicate devices in terms of intended use, materials, and technological characteristics. Performance is inferred from the established safety and effectiveness of the predicates.

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/Not provided. This 510(k) summary does not describe a clinical test set in the way one would for a diagnostic or therapeutic device requiring a standalone performance study. The equivalence is based on existing knowledge and data related to the predicate devices.

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/Not provided. There is no "test set" and thus no ground truth established by experts in the context of this 510(k) summary.

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

Not applicable/Not provided. No test set requiring expert adjudication is described.

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/Not provided. This is a bone graft substitute, not a diagnostic imaging device involving human readers or AI assistance.

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

Not applicable/Not provided. This is a physical medical device, not an algorithm.

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

Not applicable/Not provided. No specific "ground truth" for this device's performance is established in this summary. The ground for clearance is substantial equivalence to predicates, implying their historical safety and effectiveness serve as the basis.

8. The sample size for the training set

Not applicable/Not provided. No "training set" in the context of an algorithm or a clinical trial is described.

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

Not applicable/Not provided. No "training set" is described.

Summary of Device Acceptance Approach:

The Straumann Granules received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices. The "study" proving the device met "acceptance criteria" (which are implicitly suitability for its intended use based on similarity to predicates) was the submission and review of documentation confirming:

• Similar Material Characteristics: Made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite, which are common components in existing bone graft substitutes.
• Identical Intended Use: Indicated for intraoral/maxillofacial osseous defects, including periodontal, furcation, alveolar ridge augmentation, extraction sites, and sinus elevation grafting, aligning with the indications of the predicate devices.
• Technological Characteristics: By extension, the device is considered to function similarly to the predicate devices in terms of being a resorbable bone void filler replaced by bone during healing.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the regulatory acceptance criteria were met through the established 510(k) pathway of proving equivalence rather than through a direct performance study against a predefined set of quantitative numerical criteria specific to this new device.

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The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.

The provided text describes a 510(k) summary for the Straumann Ortho implant. However, it does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a previously marketed predicate device (Straumann Ortho System K982509). The rationale for substantial equivalence is explicitly stated as:

"The subject Straumann Ortho implants have the same design as the previously cleared Straumann Ortho implants. There has been no change in material, surface treatment, design, or operating principle."

This suggests that the new device is considered equivalent because it is identical to a device already deemed safe and effective, rather than a new study with performance acceptance criteria being conducted.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The 510(k) process in this instance relies on equivalence, not on new performance data against specific acceptance criteria.

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The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

The MODUS® System sagittal split plate with slider has a U-shaped design. It is available in two configurations, with six or eight screw holes. The plate is composed of CP Grade 1 titanium. The plate has a thickness of 0.7 mm and is available in a range of lengths of 31.65mm to 52.65 mm. The slider is 10 mm in diameter and is composed of Grade 4 CP titanium meeting ASTM F67.

The provided text is a 510(k) summary for the MODUS® Titanium Osteosynthesis System, specifically the Sagittal Split Plate and Slider. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and supporting data as one would find for a novel device or AI/software-as-a-medical-device (SaMD).

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance cannot be extracted because this information is not present in the document.

The document details a predicate device comparison study, which is a different type of submission for medical devices focused on demonstrating equivalence to already cleared devices.

Here's a breakdown of what can be extracted and why other information isn't available:

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

• Not Applicable / Not Provided: The 510(k) summary for this device (K993862) establishes substantial equivalence based on intended use, design, and material comparison to predicate devices, not on a new performance study with specific acceptance criteria and reported numerical performance metrics.

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 / Not Provided: This 510(k) is for a physical orthopedic implant. Clinical studies with test sets in the typical sense (like for diagnostic algorithms) are not described. The basis for equivalence is primarily engineering specifications and material properties compared to predicate devices.

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 / Not Provided: There is no mention of a test set requiring expert-established ground truth in this submission. This is not a diagnostic device or an AI/SaMD product.

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

• Not Applicable / Not Provided: No test set or adjudication method is described.

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 / Not Provided: This is not an AI/SaMD device. No MRMC study was conducted.

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

• Not Applicable / Not Provided: This is not an AI/SaMD device.

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

• Not Applicable / Not Provided: No ground truth in this context is relevant or described for this physical device submission.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no training set mentioned, as this is not a machine learning device.

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

• Not Applicable / Not Provided: No training set or ground truth for it is mentioned.

Summary of what the document DOES demonstrate:

The document demonstrates that the MODUS® Sagittal Split Plate with Slider is substantially equivalent to legally marketed predicate devices, specifically:

• MODUS® System Plates and Mesh (K946165)
• Synthes 2.0 mm Sagittal Split Plates (K981890)
• Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)

This equivalence is based on:

• Intended Use: Used for stabilization of mandibular bone segments after a sagittal split osteotomy in oral, maxillofacial surgery.
• Design: U-shaped design, available in two configurations (six or eight screw holes), 0.7 mm plate thickness, 10 mm diameter slider.
• Material: Plate composed of CP Grade 1 titanium; slider composed of Grade 4 CP titanium meeting ASTM F67.

The "study" in this context is the 510(k) submission process itself, which involves comparing the new device to predicate devices to establish substantial equivalence. It's a regulatory "study" rather than a clinical performance study with statistical endpoints. The acceptance criteria for this type of submission are met if the FDA agrees that the new device does not raise new questions of safety and effectiveness compared to the predicate device.

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The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the orgal cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.

The ITI Protection Healing Cap is a device which is mounted onto an 171 implant after the abutment has been placed into the implant and serves to protect the outer configuration of the abutment and which the clinician can modify to maintain and condition the precise contours of the soft tissue during the prosthetic phase. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The protection healing caps remain in place for approximately 2 weeks while the tinal restoration is being constructed.

The ITI Protection Healing Cap is available in two sizes. The small cap has a diameter of 5.8 mm and a height of 4.0 mm. The large cap has a diameter of 6.2 mm and a height of 5.0 mm. The Profection Healing Caps are designed with a 65° bevel which extends 0.5 mm (small) to 0.7 mm (large) beyond the outer edge of the implant making it possible to modify the dimension of the caps.

The ITI Protection Healing Caps are composed of Polyetheretherketone (PEEK) which is extruded from its granulated form and lathed to form the caps.

The provided text describes a medical device, the ITI Protection Healing Cap, and compares it to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or any details related to AI, algorithms, or human reader performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, AI/algorithm performance) is not present in the provided text.

Specifically, the document is a 510(k) summary for a physical medical device (a dental healing cap), not an AI/software device. The sections you requested (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are typically relevant for studies evaluating the performance of diagnostic or prognostic algorithms, especially in imaging or data analysis.

The document focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use: What the device is for.
• Comparison to Predicate Devices: Showing that the new device is substantially equivalent to existing, legally marketed devices based on features like material, design (dimensions), and intended use.

There is no mention of any study to prove specific performance metrics or acceptance criteria beyond the general concept of substantial equivalence to predicate devices for regulatory clearance.

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The esthetic healing caps are intended to protect the inner configuration of the M implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft fissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

The ITI esthetic healing caps are titanium devices which are mounted onto an ITI implant before the soft tissue is sutured in place around the implant. These healing caps are intended to protect the inner configuration of the ITI implant and the 45s outer shoulder of the implant during the healing phase after the placement of the implant. The esthetic healing caps also serve to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing caps is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The esthetic healing cap remains in place for six to twelve weeks.

The ITI esthetic healing cap is available in two heights (2.0 mm and 3.5 mm). Each cap consists of two parts: the body of the healing cap itself and a corresponding occlusal screw which aftixes the cap onto the implant. The healing caps and the occlusal screws are composed of commercially pure Grade 4 titanium meeting ASTM F67-95.

The esthetic healing caps are designed with a bevel which should be positioned either labially or bucally. This bevel enables positioning of the mucoperiosted! flap over the esthetic healing cap after implant placement without subjecting the flap to tension.

This is a pre-amendment 510k submission for a medical device from 1996. The provided text is a 510(k) Summary, which is a regulatory document to demonstrate substantial equivalence to legally marketed devices. It outlines the device's features and intended use but does not contain information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert involvement. These types of details are typical for modern AI/ML device submissions, which did not exist at the time this document was created.

Therefore, I cannot provide the requested information based on the provided text.

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The device is intended for surgical placement in maxillary and/ or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared 11 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 um thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 4.1 mm Solid Screw Implant.

For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal tit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking triction fit (similar to Morse taper, a principle that has been used in machine shops for many years).

The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm.

Accessories: The surgical technique intended for the implant includes initial use of the same IT 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by The use of the standard ITI 3.5 mm twist drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).

The provided document is a 510(k) Summary for the ITI Wide Diameter Implant. While it details the device's characteristics and compares it to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The study described is a nonclinical test comparing the strength of the ITI Wide Diameter Implant to a predicate device. This is a performance test for a medical device (an implant), not a study for an AI/ML device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

However, I can extract information about the nonclinical test described:

1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Study)

Explanation of Implied Acceptance Criteria: The stated objective of the nonclinical test was to demonstrate the substantial equivalence of the new device by showing it performs at least as well as, and in this case, better than, a predicate device specifically in terms of strength and bending. The acceptance criteria are implicitly defined as "exceeding" or being "substantially stronger than" the predicate device's performance.

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

• Sample Size: Not explicitly stated. The text says "Implants were imbedded..." and "Force vs. deflection curves were recorded for each test." It does not specify the number of implants or tests performed.
• Data Provenance: Not specified, but given it's a nonclinical test performed by the applicant (Straumann USA), it's likely internal lab testing.

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

• Not applicable. This was a physical strength test, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This was a physical strength test.

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 was a physical strength test, not an AI/ML study.

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

• Not applicable. This was a physical strength test, not an AI/ML study.

7. The type of ground truth used:

• Ground Truth: Physical measurement of failure loads and observation of failure modes during mechanical testing.

8. The sample size for the training set:

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

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

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

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