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The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Prima Plus™ Conical Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The purpose of this submission is for the marketing clearance for Prima Plus Conical Implants, an endosseous root-form dental implant. The overall system is designed to be used with compatible components and are indicated for single-unit, multi-unit and overdenture restorations. No new prosthetic components were designed as part of this submission, with these implants designed to be compatible with previously cleared prosthetic components.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Prima Plus Conical Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Prima Plus Conical Includes previously marketed abutments with fifteen (1 5) designs: Healing Abutments, Straight (with and without TiPink), Angled (with and without TiPink), Straight Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder (with and without TiPink), Titanium Temporary Immediate (with and without TiPink), Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

lmplants are fabricated from a Titanium 4 Vanadium ELI titanium alloy which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications (UNS R56401). They have a Sandblasted, Large grit and Acid-etched (SLA) surface treatment.

All implants are one-time use devices All Subject device components are provided sterilized by gamma irradiation.

The provided text is a 510(k) summary for a medical device (Keystone Dental Inc.'s Prima Plus Conical Implant System). It describes the device, its intended use, and how it is substantially equivalent to previously marketed devices based on non-clinical performance testing.

However, the document does not contain information typically found in a study proving device performance against acceptance criteria for AI/ML-enabled devices, especially regarding clinical performance, human-in-the-loop studies, or the establishment of ground truth by experts.

The key phrases from your request which are not addressed in the provided text are:

• "Acceptance criteria and the study that proves the device meets the acceptance criteria."
• "Table of acceptance criteria and the reported device performance." (beyond static mechanical testing)
• "Sample sized used for the test set and the data provenance." (There's no clinical test set described)
• "Number of experts used to establish the ground truth for the test set and the qualifications of those experts."
• "Adjudication method for the test set."
• "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."
• "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
• "The type of ground truth used (expert consensus, pathology, outcomes data, etc)."
• "The sample size for the training set."
• "How the ground truth for the training set was established."

The document explicitly states: "No clinical data were included in this submission." This means there are no studies involving human patients or complex data analysis that would require features like AI models, human readers, or ground truth establishment by medical experts.

The "acceptance criteria" and "device performance" mentioned are limited to:

• Non-Clinical Performance Testing:
  • Fatigue testing per ISO 14801:2016 (Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants). This is a mechanical test.
  • Biological Evaluation per ISO 10993-1.
  • Sterilization information leverage (from a reference device, K220200).
  • MRI review (non-clinical, using scientific rationale and published literature).

The "study" that proves the device meets the acceptance criteria is primarily benchtop mechanical performance testing (ISO 14801) on "worst-case constructs" to demonstrate "suitability for intended use."

Therefore, I cannot provide a table or details on the ground truth, expert involvement, or clinical study design as requested for an AI/ML device, because this 510(k) filing for a dental implant does not involve such elements. It is a physical medical device, and its equivalency is based on material properties, design comparisons, and mechanical durability.

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The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Genesis ACTIVE Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

The purpose of this submission is for the marketing clearance for the Genesis ACTIVE Implant System which comprises endosseous root-form dental implants, mating compatible abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Genesis ACTIVE Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Genesis ACTIVE Implant System includes eleven (11) compatible implant abutment designs: Healing Abutments, Straight, Angled Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder, Titanium Temporary Immediate, Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, ANGLEBase®, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device Multi-Unit abutments. The overdenture bar is a dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial or totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology by a Keystone Dental Group company and is used to facilitate the attachment of both fixed and removable prostheses.

Subject device implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium and ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700). They are anodized pink (AnaTite™) to provide a pink color and have the BioSpark™ surface treatment which results in a hydrophilic surface enriched with calcium and phosphorous ions.

All titanium Subject device abutments, accessories and screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R5640). Except for the Titanium Blank abutment design, all titanium Subject device abutments are anodized pink. Post surfaces of select abutments receive a media blasting treatment referred to as AnaTite™ or TiPink.

Subject device PEEK temporary abutments are fabricated from PEEK (PolyEther Ether Ketone) material.

All implants and prosthetic components are one-time use devices. All Subject device components are provided sterile and sterilized by gamma irradiation, except for Titanium Blank abutments and the KDG-Osteon Precision Milled Suprastructure which are provided non-sterile. Devices provided non-sterile or modified are sterilized by steam.

The provided text describes the 510(k) summary for the Keystone Dental Inc. "Genesis ACTIVE Implant System." It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The document explicitly states that no clinical data were included in this submission, which means there was no study proving the device meets acceptance criteria related to human performance or clinical outcomes.

Therefore, many of the requested information points, particularly those pertaining to acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert involvement in ground truth establishment for such studies, MRMC studies, and standalone performance, cannot be answered from the provided text.

The document primarily discusses bench testing and material/design comparisons to establish equivalence, rather than clinical performance acceptance criteria or studies involving human readers or AI.

Here's what can be extracted from the provided text:

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

The document focuses on non-clinical performance testing (bench testing) and material/design specifications for establishing substantial equivalence, rather than specific performance metrics or acceptance criteria typically seen for AI/diagnostic devices in clinical settings. The acceptance is based on demonstrating the new device performs similarly and is as safe and effective as the predicate device through these non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it relies on non-clinical data (bench testing) rather than a clinical test set. The number of samples for each bench test is not specified in this summary document.
• Data Provenance: Not applicable for clinical data. For non-clinical (bench) testing, the tests were conducted according to recognized international standards (e.g., ISO, ASTM, USP).

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

• Not applicable. No clinical test set or ground truth established by experts is described, as the submission focuses on non-clinical data.

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

• Not applicable. No test set requiring adjudication in a human reader study 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:

• No MRMC study was done. The document explicitly states: "No clinical data were included in this submission."

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

• Not applicable. This device is a physical dental implant system, not an AI algorithm. Its "performance" is mechanical and biological, not diagnostic or algorithmic.

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

• Not applicable for clinical ground truth. The "ground truth" for this submission are the standards and specifications (e.g., ISO 14801 for mechanical fatigue, ISO 10993 for biocompatibility) against which the device's physical and material properties are tested in a lab setting.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires training data.

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

• Not applicable. This is not an AI/machine learning device.

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KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B.

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.

Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.

The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.

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The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw.

The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.

The provided text is a 510(k) Premarket Notification from the FDA for the Keystone Dental XL Dental Implant System. It discusses the device's administrative information, indications for use, device description, performance data, and a comparison to legally marketed predicate devices to demonstrate substantial equivalence.

However, it does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

The document details non-clinical performance data for physical characteristics of the dental implant (sterilization validation, biocompatibility, bacterial endotoxin testing, modified surface analysis), and relies on established standards (ISO, ASTM, FDA guidances) and substantial equivalence to predicate medical devices for these aspects. There is no mention of an "algorithm" or "AI assistance" in this document.

Therefore, I cannot extract the requested information as it is not present in the provided text. The device being reviewed is a physical implant, not an AI/ML-based diagnostic or therapeutic tool.

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The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.

The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.

The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.

The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.

The device is provided non-sterile to the user in medical grade packaging.

Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the XP1 Angled Abutments, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study on the XP1 Angled Abutments themselves.

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

This information is not applicable as the document does not describe a performance study involving a test set that required expert-established ground truth. The primary method of demonstrating acceptance was substantial equivalence to previously cleared devices.

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

This information is not applicable as the document does not describe a performance study involving a test set that would require an adjudication method.

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

This information is not applicable. The device is an angled dental abutment, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

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

The document does not describe a study that required a "ground truth" in the typical sense for analytical or clinical performance evaluations. Instead, the "ground truth" for the device's acceptance was:

• Conformance to Industry Standards: The material composition (Ti-6AL-4V ELI conforming to ASTM F136) is a verifiable standard based on material science and engineering specifications.
• Substantial Equivalence: The primary "ground truth" for regulatory clearance was a comparison to predicate devices, meaning the regulatory body (FDA) determined the XP1 Angled Abutments were sufficiently similar in design principles, materials, and intended use as devices already legally marketed and deemed safe and effective.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set."

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

This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set" or its associated ground truth establishment.

Summary of the "Study" for Acceptance:

The submission for the XP1 Angled Abutments (K090397) primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new clinical trials or extensive performance studies on the new device, the manufacturer demonstrated that the XP1 Angled Abutments were:

• Identical or substantially equivalent in intended use.
• Identical or substantially equivalent in material composition (Ti-6AL-4V ELI conforming to ASTM F136).
• Identical or substantially equivalent in design principles.

The FDA reviewed this comparison and a description of the device's characteristics to determine that it was as safe and effective as the predicate devices already on the market. The letter from the FDA confirms this determination of substantial equivalence, which is the "study" or justification for its acceptance into the market. No specific performance study with a test set, ground truth, or expert involvement as typically understood for software or diagnostic devices is described.

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The Olympus Dental Implant System is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability.

The Olympus Dental Implant System includes various sizes of parallel sided, threaded, root-form dental implants and straight abutments intended to support prosthetic restorations in edentulous or partially edentulous patients. The implants can be placed immediately following extraction or after a healing period. If good primary stobility is reached according to the Instructions for Use, Olympus Dental Implants with an insertion depth of 8 mm or more may be immediately loaded. The system includes a variety of laboratory (burnout) copings, impression copings, analogs and other components (Class 1 exempt, not a subject of this submission) intended to facilitate the prevaration of prosthetic restorations.

This document describes the Olympus Dental Implant System, which is a Class II medical device. The information provided outlines its intended use and describes its equivalence to already marketed devices, but it does not include a study describing acceptance criteria or performance metrics in the way one might find for a diagnostic or AI-driven device.

Therefore, I cannot populate the table or answer most of the questions as the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and detailed test results.

Here's an explanation based on the provided text:

• Type of Device: The Olympus Dental Implant System is a physical dental implant system, not a diagnostic or AI-powered software device.
• Regulatory Pathway: The submission is a 510(k) premarket notification. This pathway primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for novel performance metrics.
• Lack of Performance Study Data: The provided text does not contain any sections detailing a study with acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. The "DEVICE DESCRIPTION" and "EQUIVALENCE TO MARKETED PRODUCT" sections confirm this focus on equivalence in design and indications for use.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission.
2. Sample size used for the test set and the data provenance: No performance study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study described.
4. Adjudication method for the test set: No performance study described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical implant, not an AI or diagnostic tool.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: No training set for an algorithm described.
9. How the ground truth for the training set was established: No training set for an algorithm described.

Summary of available information:

• Device Name: Olympus Dental Implant System
• Intended Use: "To be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Olympus Dental Implants with an insertion depth of 8 mm or more can be loaded immediately if they have achieved adequate primary stability."
• Regulatory Classification: Class II (Endosseous dental implant - 21 CFR 872.3640; Endosseous dental implant abutment - 21 CFR 872.3630).
• Equivalence: The manufacturer "demonstrated that... the Olympus Dental Implant System is substantially equivalent in indications and design principles to predicate devices."

The 510(k) process for devices like dental implants primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, materials testing, and comparison of design features, rather than extensive clinical performance studies with specific numerical acceptance criteria for diagnostic accuracy or algorithmic performance as would be seen for AI/ML devices.

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EasyGuide is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the EasyGuide treatment planning software.

Not Found

This FDA 510(k) clearance letter for the "EasyGuide" device, a software for pre-treatment planning of dental implants based on CT scans, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter is a notification of substantial equivalence to a predicate device, which means the FDA has determined it is as safe and effective as a legally marketed device. It does not typically include the in-depth technical performance characteristics or detailed study results that would satisfy your request for acceptance criteria and supporting study data.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance: This information is completely absent.
2. Sample size used for the test set and data provenance: No details on testing, sample sizes, or data origin are provided.
3. Number of experts used to establish ground truth and their qualifications: This is not mentioned.
4. Adjudication method for the test set: No information on this.
5. MRMC comparative effectiveness study details: This type of study is not mentioned or summarized.
6. Standalone (algorithm only) performance study details: Not present.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable, as this document is not about algorithm training or validation in that context.
9. How ground truth for the training set was established: Not applicable.

The letter focuses on the regulatory aspects of 510(k) clearance, such as product code, regulation number, substantial equivalence determination, and general controls. It refers to the "Indications for Use" for the device on the enclosed page, which is a high-level description of its intended use, but not performance specifications.

To obtain the information you're looking for, you would generally need to consult the actual 510(k) submission document itself, which contains the detailed testing and validation data provided by the manufacturer to the FDA. This summary letter does not include that level of detail.

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