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The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications. The screws consist of either three or four components: head, platform, body (thread) or moreover neck.

The provided text describes a 510(k) summary for PSM LOMAS / BENEFIT Screws, a type of orthodontic mini-anchor system. It details the device description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, the document does not provide specific acceptance criteria or details about a study proving the device meets those criteria.

The "Performance data" section only lists the types of tests performed:

• Breakage and Fatigue Tests
• Material Tests
• Validation Tests of sterile barrier system and packaging system
• Sterilization Validation Tests
• Microbiological Test for determination of microorganisms
• Several Clinical Justifications and Studies

It does not provide:

1. A table of acceptance criteria and the reported device performance: The document mentions tests were performed but does not list specific criteria or the results against them.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present, as no specific performance study with a test set is detailed.
4. Adjudication method for the test set: Not applicable as a performance study involving a test set and ground truth is not detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for this type of medical device (physical screw vs. diagnostic AI).
6. If a standalone performance study was done: The document states "Several Clinical Justifications and Studies" were performed but does not describe the methodology or results of any such standalone study.
7. The type of ground truth used: Not applicable as specific performance studies involving ground truth are not detailed.
8. The sample size for the training set: Not applicable as this is not an AI/ML device where a training set would be relevant in the traditional sense. The "training" here would be related to engineering design and material science.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document states that various tests and studies were performed to support substantial equivalence but does not provide the detailed information requested regarding specific acceptance criteria and the evidence proving the device meets them. The filing primarily relies on demonstrating equivalence to predicate devices based on technical characteristics, indications for use, material, target population, performance, safety, effectiveness, and biocompatibility.

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AEDIS ™ provides a self tapping titanium screw indicated for immediate transitional splinting stability, or long term intra-bony applications such as fixation of new or existing crown, bridge or denture installations in partially or fully edentulous mandibles and maxillae.

Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.

The device is a Titanium alloy, root form implant system consisting of: a self-tapping 1.8 mm diameter implant screw with an integrated hexagonal fitment for attachment of an abutment, and a cap screw designed to lock the abutment to the implant screw. AEDIS™ abutments are not angled.

AEDIS ™ follows natural tooth morphology and is recommended for use in mandibular and maxillary anterior locations for restoration applications. The screw diameter is 1.8mm and is offered in lengths of 13.5 and 15mm. A minimally invasive procedure allows for immediate placement, and temporization in single and multiple tooth restorations. The implant screws are self tapping.

A titanium abutment is provided and is intended to be mechanically affixed to the screw to hold a crown, bridge, or other prosthetic appliance. The prosthesis may be secured to the abutment by the use of adhesives or mechanically by the use of a screw. The abutment is cone shaped; 8 mm in height; has a hexagonal fitment to provide for the cap screw) to lock the abutment the implant screw. The 5 mm diameter of the base of the abutment is identical to the diameter of the top of the implant screw. When all elements of the system are attached to each other the tolerances between the parts are 3 microns or less.

Immediate loading is not recommended where there is inadequate stability. Immediate loading should occur when the position of the implant provides adequate bone quality and quantity to allow proper immediate mechanical stabilization of the self tapping screw into the bone, and where occlusal and lateral forces can be limited with appropriate occlusal design when splinted. Dietary restrictions may also be required by the surgeon performing the implant procedure.

AEDIS™ is offered in a kit including: implant components; surgical instruments; a tissue punch, leveling bit, and implant insertion instruments. The package also includes recommended surgical protocols, and illustration of recommended insertion techniques. The kit is packaged in a plastic container with appropriate labeling. The AEDIS ™ is delivered in sterile condition, however many practitioners also autoclave the device in their own Operatories.

The provided text describes a 510(k) summary for the AEDIS™ (Adams Embed Dental Implant System), a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone clinical study of the new device.

Therefore, the document does not contain information typically found in a study proving a device meets specific performance acceptance criteria, especially for AI/software-as-a-medical-device (SaMD) where metrics like sensitivity, specificity, or reader improvement are common.

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

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

   • Not present. This document discusses substantial equivalence to a predicate device, not performance against specific, predefined acceptance criteria with numerical results. It states, "EMBED has provided test results and related scientific data demonstrating the substantial equivalence of the IMTEC predicate device and AEDIS™." However, the results themselves or specific performance metrics are not detailed. The table provided in the document focuses on technological characteristics for comparison, not performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not present. No test set size, data provenance, or study design (retrospective/prospective) is described. The document indicates that "tests were performed at an independent, highly qualified laboratory," but does not provide details about these tests.

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 present. Since no specific test set or ground truth establishment is described, this information is not available.

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

   • Not present. No adjudication method is mentioned as there's no description of a study involving expert review for a test set.

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 present. This document describes a dental implant, which is a physical device, not an AI or software product. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

   • Not present. As mentioned, this is a physical dental implant, not an algorithm.

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

   • Not present. There is no mention of a ground truth in the context of a performance study for the AEDIS™. The "ground truth" for a 510(k) is typically the predicate device's established safety and effectiveness.

8. The sample size for the training set

   • Not present. Training sets are relevant for machine learning or AI models, which this device is not.

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

   • Not present. See point 8.

Summary of what is available from the text regarding the "study":

The "study" referenced in this document is not a clinical performance study with predefined acceptance criteria for the AEDIS™ itself. Instead, it is a substantial equivalence comparison to a predicate device (Imtec 1.8 mm diameter implant K031106 and others).

• Acceptance Criteria for 510(k): The overarching "acceptance criterion" for a 510(k) submission is demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate.
• Device Performance (as reported for the 510(k)): The document states: "EMBED has provided test results and related scientific data demonstrating the substantial equivalence of the IMTEC predicate device and AEDIS™." It further notes: "The tests were performed at an independent, highly qualified laboratory who certified the accuracy of the test results."
• Technological Characteristics Comparison (instead of performance table): The document provides a comparison table of technological characteristics:

In conclusion, the provided text details a 510(k) submission focused on demonstrating substantial equivalence of a physical medical device (dental implant) to a predicate device, rather than a performance study meeting specific, quantified acceptance criteria typically seen for new, innovative technologies or AI/SaMD products. Therefore, most of the requested information (sample sizes, expert qualifications, ground truth methods, MRMC studies) is not applicable or not present in this type of regulatory document.

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The BioHorizons Maestro System 3.0 mm 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. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
• (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 Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. 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 resorbable blast media (RBM). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components.

This document is a 510(k) summary for a dental implant, not a study report for a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not present in the provided text.

Based on the provided text, here is what can be extracted and what cannot:

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

• Cannot be provided. The document describes a medical device (dental implant) and its substantial equivalence to predicate devices for regulatory clearance. It does not detail specific acceptance criteria or performance metrics in the way a clinical or technical performance study would. It focuses on the device's characteristics and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. This document is not a study report. It does not mention any test sets, sample sizes, or data provenance.

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)

• Cannot be provided. No ground truth establishment for a test set is mentioned in this regulatory submission document.

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

• Cannot be provided. No adjudication method is mentioned as there is no test set or study 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

• Cannot be provided. This device is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not applicable to this submission.

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

• Cannot be provided. This device is a dental implant, not an algorithm.

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

• Cannot be provided. No ground truth is described in the context of a performance study.

8. The sample size for the training set

• Cannot be provided. This document is not about an AI device with training sets.

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

• Cannot be provided. Not applicable to this type of device and document.

Summary of what is present:

The document is a 510(k) Pre-market Notification for a dental implant, demonstrating substantial equivalence to previously cleared predicate devices. The focus is on the physical characteristics, materials, manufacturing processes, and intended use being similar to existing, legally marketed devices. The "study" here is essentially the comparison to predicate devices, asserting that its "Technological Characteristics" are "identical or very similar" and "substantially equivalent to all features of the predicate devices which could affect safety or effectiveness because of the similarities in design, material and intended use."

The regulatory body (FDA) reviewed this claim and, in the letter, indicated that the device is "substantially equivalent" for the stated indications for use. This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, implying that if the new device is as safe and effective as a legally marketed predicate, it can be marketed. No new clinical trials or performance studies against specific numerical acceptance criteria are detailed in this type of submission.

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