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The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental supra-structures (false teeth).

The modification is to be able to use stronger titanium because of situations in which this could be beneficial. Since B.A.S.I.C. Dental has been approved as a system using CP Titanium, which is the weakest of the standard titanium available, we would like to be able to use stronger titanium to increase the overall strength of the implant. By using stronger titanium there should be no need for further testing, however the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints.

I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a dental implant modification, focusing on material changes and substantial equivalence to a predicate device. It discusses:

• Device Identification and Modification: B.A.S.I.C. Dental Implant System, modified to use stronger titanium.
• Intended Use: Identical to the predicate device, for replacing missing teeth.
• Comparison to Predicate Device: Argues substantial equivalence based on identical dimensional characteristics and indications for use. Mentions other predicate devices with similar dimensions and titanium alloy materials.
• Testing: States that "the following tests were performed to compile with design controls. The testing revealed as expected that implants produced with stronger titanium had better shear/lateral forces, with no lateral constraints."
• Sterilization and Biocompatibility: Confirms the sterilization process remains the same and references ISO standards.
• Conclusion: Reaffirms substantial equivalence.
• FDA Letter and Indications for Use: The official FDA clearance letter and the stated indications for use.

Crucially, it does not provide details about acceptance criteria, specific study designs, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers (MRMC studies). The mention of "testing revealed... better shear/lateral forces" is too high-level to infer specific acceptance criteria or detailed study methodologies.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, ground truth, or expert involvement based on the provided text.

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The BioHorizons Maximus 3.0 Implants may be used (1) as a nrtificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occusion, (2) when Splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function; (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

The BioHorizons Maximus OS Implants may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

The BioHorizons Maximus 3.0mm and OS implants are machined titanium, screw-form implants supplied in lengths of 12mm, 15mm and the Maximus OS implant is further supplied with tissue collar heights of 2mm and 4mm, available with each length. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The device is further processed by treating the surface with Hydroxylapatite (HA) media to promote implant fixation. The product is packaged using materials known in the to promote impropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-8, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control -Radiation Sterilization.

The Maximus 3.0mm and OS implants are comprehensive systems containing implants and surgical components. The Maximus 3.0mm diameter implant may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors, with or without tissue reflection; (2) when splinted indeers an an artificial root structure for multiple tooth replacement of mandibular incisors; and, (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. In single cases they may be placed in immediate function out of occlusion with a temporary prosthesis. The Maximus OS implant is a system with the implants configured specifically for use in denture stabilization; reference the Intended Use section following.

All BioHorizons implants referenced in this submission are 3.0mm in diameter with surface treatment using Hydroxylapatite coating.

The provided document is a 510(k) summary for a medical device modification (BioHorizons HA-Coating Maximus™ 3.0 & OS Special implants). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

Here's why and what information is present:

• 510(k) Summary Purpose: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). The primary focus is on "substantial equivalence" based on technological characteristics, intended use, and materials.
• Lack of Performance Data: 510(k) submissions typically do not require extensive clinical trial data or detailed performance metrics against pre-defined acceptance criteria in the way a PMA or a de novo submission might. Instead, they rely on demonstrating that the new device is "substantially equivalent" to existing, cleared devices.
• Focus on Substantial Equivalence: The document explicitly states: "The fundamental scientific technology of the device is identical to the referenced predicate devices. All materials, suppliers, processing, packaging and sterilization methods remain the same... The Maximus 3.0 and OS implants are substantially equivalent to all features of the predicate devices which could affect safety or equivalent to an assessment of the similarities in design, material and intended use."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance because this information is not present in the provided 510(k) summary.

The document does provide:

• Proprietary Name: The Maximus™ 3.0mm and OS Implants
• Common Name: Screw-type Dental Implant
• Classification Name: Endosseous implants, surgical components, and prosthetic attachments
• Predicate Devices:
  • BioHorizons Dental Implant System (K960026)
  • BioHorizons the Maestro System™ 3.0mm diameter implant (K032351)
  • BioHorizons Maximus OS (Overdenture System) Implant (K041938)
• Device Description: Machined titanium, screw-form implants with Hydroxylapatite (HA) coating. Lengths of 12mm, 15mm, 18mm, and OS implant variations with 2mm and 4mm tissue collar heights. Material: ASTM F 136 titanium alloy.
• Intended Use:
  • Maximus 3.0mm implant: Single tooth replacement (mandibular central/lateral incisors, maxillary lateral incisors, immediate restoration out of occlusion), multiple tooth replacement when splinted (mandibular incisors), denture stabilization (anterior mandible/maxilla).
  • Maximus OS implant: Denture stabilization (anterior mandible/maxilla).
• Sterility: Minimum sterility assurance level of 10-8, validated in compliance to ANSI/AAMI/ISO 11137.

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