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BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

The BioHorizons Tapered Short Implants are machined titanium, screw-form endosseous dental implants supplied in 4.6mm and 5.8mm diameters. The 4.6mm diameter implant includes a 3.5mm prosthetic platform, while the 5.8mm diameter implant includes a 4.5mm prosthetic platform. The implants are provided in 6.0mm and 7.5mm lengths across both diameters. Implant material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by micro-machining grooves, known as Laser-Lok® microchannels, on the implant collar. 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 with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

The provided document is a 510(k) premarket notification for a medical device, specifically dental implants. It outlines the substantial equivalence of the BioHorizons Tapered Short Implants to legally marketed predicate devices. This type of submission focuses on demonstrating equivalence rather than proving safety and effectiveness through clinical trials in the same way a PMA (Premarket Approval) would.

Therefore, the study design elements typically found for AI/ML device evaluations (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this document as it pertains to a mechanical dental implant, not an AI/ML diagnostic or therapeutic device.

The study described here is primarily bench testing to demonstrate mechanical and material properties, and to verify sterilization and biocompatibility.

Here's the breakdown of the closest applicable information based on your request, understanding the context of a 510(k) for a physical medical device:

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

The document doesn't present a formal "acceptance criteria" table in the way one might for a diagnostic test with metrics like sensitivity/specificity. Instead, it describes performance based on industry standards and comparative testing against predicate devices.

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

• Mechanical Fatigue Testing (ISO 14801): "worst-case (smallest prosthetic platform/smallest implant body diameter combined with the shortest implant length) 4.6mm x 6.0mm Tapered Short Implant was performed". The exact N (number of implants tested) is not specified, but typically for such tests, a statistically relevant number (e.g., n=12 or similar based on ISO standards) would be used.
• Bacterial Endotoxin/Sterilization Validation/Shelf Life: "representative worst-case BioHorizons endosseous dental implant devices" / "representative worst-case BioHorizons dental implant devices". Exact N not specified. "all lots tested" for endotoxins.
• Surface Area/BIC/Axial Pullout: "shortest length worst-case subject implants across both offered implant diameters" compared to "shortest length worst-case primary predicate implants across equivalent implant diameters." Exact N not specified.
• Data Provenance: The studies were conducted internally by BioHorizons or by their A-level supplier. The document does not specify country of origin for the data, but implied to be in compliance with US regulatory requirements (FDA). These are prospective tests performed on manufactured devices.

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

• Not applicable. This pertains to a mechanical device, not imaging data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests comes from physical measurements, chemical analyses, and adherence to validated international standards (ISO, ASTM, USP).

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

• Not applicable. This is relevant for human-interpreted data, not for direct physical measurements and compliance with engineering standards.

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 a study design for AI/ML diagnostic devices, not for mechanical implants.

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

• Not applicable. This refers to AI/ML algorithm performance.

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

• For this device, the "ground truth" is established by:
  • Validated laboratory measurements: e.g., bacterial endotoxin levels, gamma radiation dose verification, elemental analysis (EDX).
  • Adherence to national and international standards: ASTM (e.g., F136, F543), ISO (e.g., 14801, 11137-1), ANSI/AAMI, USP.
  • Comparative analysis against predicate devices: Demonstrating similar or superior performance on relevant mechanical and surface characteristics.
  • Published literature: For claims regarding Laser-Lok® microchannels (Nevins et al. study cited for connective tissue attachment claims).

8. The sample size for the training set:

• Not applicable. This applies to machine learning, not mechanical device testing.

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

• Not applicable. This applies to machine learning, not mechanical device testing.

In summary: The provided document is a 510(k) submission for a physical dental implant. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence through a series of bench tests and adherence to established material, manufacturing, and sterilization standards, rather than clinical trials or AI/ML performance evaluations.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.

The provided 510(k) summary for the Neodent Implant System does not contain information related to acceptance criteria or a study proving device performance against such criteria.

The document is a premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a clinical study or benchmark performance testing with ground truth.

Therefore, many of the requested elements cannot be extracted from this document, as they are not present in a "substantial equivalence" submission for this type of device.

Here's an breakdown of what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not applicable. No clinical or performance test data on a "test set" are presented.
• Data Provenance: Not applicable. The submission explicitly states: "Clinical data were not submitted in this premarket notification." The non-clinical data mentioned (engineering analysis, dimensional analysis, comparative surface area analysis) would not typically involve a "test set" in the sense of patient data.

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. As no clinical or performance test data are presented, there is no "ground truth" established by experts for a test set in this submission.

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

• Not applicable. No test set requiring 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 is a submission for a physical medical device (dental implants), not an AI diagnostic tool. No MRMC study was done, nor is AI assistance relevant to this device.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. No performance data requiring ground truth ascertainment is presented. The submission relies on "substantial equivalence" based on design, materials, and non-clinical characteristics (engineering, dimensional analysis) comparing the new device to existing predicate devices.

8. The sample size for the training set

• Not applicable. As no machine learning or AI model is involved, there is no "training set."

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

• Not applicable. No machine learning or AI model is involved, so no training set or ground truth for it was established.

Summary based on the provided document:

The 510(k) summary for the Neodent Implant System explicitly states: "Clinical data were not submitted in this premarket notification." The submission focuses on demonstrating that the new components of the Neodent Implant System are "substantially equivalent" to predicate devices already cleared for market. This equivalence is based on:

• Identical intended use.
• Similar design, identical material, and identical surface to a previously cleared Neodent system (K101945).
• Similar indications, design, and dimensions to other predicate devices for the new Titamax WS and Facility implants.
• Non-clinical data including engineering analysis, dimensional analysis, and comparative surface area analysis.

The conclusion drawn is that "The device is safe and effective for its intended use and performs as well as or better than the predicate devices," based on the comparison of an existing cleared device characteristics rather than new performance data against specific acceptance criteria.

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Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants, or when using any 5 mm or 6 mm length implant.

The Quantum Dental Implant System includes root form, endosseous dental implants with internal Morse taper and external hex abutment interfaces. The implants are made of titanium alloy with three surface options (RBM, acid etch, HA coated), and are provided in both threaded and a grooved (fin-type) designs. There are four sizes of the internal Morse taper (implant well), designated as the 2.0, 2.5, 2.75, and 3.0 Series. For all series, the threaded and fin-type implant designs are each provided in the following sizes: diameters of 4.5, 5.0, 5.5, and 6.0 mm, with each diameter in lengths of 5, 6, 9, 11, and 14 mm. The 2.0 Series of the threaded and fin-tvpe implant designs also include: 4.0 mm diameter in 5 and 6 mm lengths, 8.0 mm diameter implants in 5 and 14 mm lengths, and 5.0 mm diameter available only in lengths of 5 and 6 mm. The 2.5 Series of the threaded and fin-type implant designs also include 4.0 mm diameter in lengths of 5, 6, 9, 11, and 14 mm.

Abutments for cement-retained prostheses are provided for each diameter implant. All abutments are made of titanium alloy. Abutments with a Morse taper interface are provided for all implant series in straight, 15° and 25° angled designs. The 2.0 Series Morse taper abutments are provided in 5 mm and 7 mm platforms; all other Series are provided in 3.5, 4, and 5 mm platforms. External hex interface abutments are provided for the 2.5. 2.75. and 3.0 Series implants in straight, 15° and 25° angled designs. The 2.5 Series hex abutments are 4 mm platform; the 2.75 and 3.0 Series hex abutments are 4.5 mm platform. Healing plugs are provided for each implant series in titanium alloy and polyethylene.

The Quantum™ Dental Implant System is a medical device and its 510(k) summary does not contain information typically found in a study for AI/Software as a Medical Device (SaMD) products. Therefore, the questions related to AI/SaMD specific criteria, such as acceptance criteria based on performance metrics, ground truth establishment for algorithms, and human-in-the-loop studies, cannot be fully answered from the provided document.

This submission is for a traditional dental implant system, and its "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing, rather than performance metrics of an AI algorithm.

However, I can extract information regarding the non-clinical testing performed to establish substantial equivalence.

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

Since this is a dental implant system (a hardware device), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices. The performance criteria are therefore related to mechanical and physical properties rather than diagnostic accuracy.

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

This document describes a premarket notification (510(k)) for a medical device (dental implant system), not an AI/SaMD product. Therefore, the concept of "test set" in the context of an algorithm's performance data does not apply here. The "testing" refers to non-clinical laboratory tests.

• Sample size for testing: Not specified in terms of number of devices tested, but the non-clinical tests mentioned are: "detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based tests typically conducted on a representative sample of finalized devices.
• Data provenance: Not applicable in the context of clinical data for AI/SaMD. The non-clinical testing would have been conducted by the manufacturer or a contracted testing facility.

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)

This is not applicable to this 510(k) submission. "Ground truth" in this context would refer to objective measurements and standard test methods (e.g., ISO 14801) for evaluating the physical and mechanical properties of the dental implants, rather than expert consensus on diagnostic images.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/SaMD datasets where expert disagreement needs to be resolved. This document focuses on non-clinical engineering and material equivalence.

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 a conventional medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of "human readers" and "AI assistance" do not apply.

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

Not applicable. This is a physical medical device, not an algorithm or software.

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

For the non-clinical testing, the "ground truth" or reference for evaluating performance would be recognized ASTM or ISO standards (specifically ISO 14801 for static and dynamic compression-bending testing), engineering specifications, and established material properties for titanium alloys. These are objective, scientifically defined standards, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

Not applicable. There is no software algorithm or AI model being trained for this device.

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

Not applicable. There is no software algorithm or AI model being trained for this device.

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