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MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The long MIS (18 & 20 mm) implants can be used in a tilted manner.

MIS short implants are to be used only with straight abutments.

M4 short implants are indicated for delayed loading only.

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

• . Narrow platform: 1, 2, 3, 4, 5 mm
• . Standard platform: 1, 2, 3, 4, 5 mm
• Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Regarding the other points of the prompt, as applied to this document:

2. Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

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The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

The OT Equator abutments are indicated for use with the following implant systems: (list of compatible implant systems follows)

The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla. The device is intended for use in healthcare facilities/hospitals.

The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.

The abutments are for straight use only and are recommended for placement on straight implant bodies with no divergence or need for angle corrections.

The OT Equator is manufactured of titanium Ti-6Al-4V (meets ASTM Standard F-136) and it is designed to retain any prosthetic restoration.

The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the OT Equator dental implant abutment. It is a regulatory document and does not contain information about the acceptance criteria or study performance of an AI/ML device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study effect size
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence of the OT Equator device to previously cleared predicate devices based on materials, design, intended use, and manufacturing processes, rather than presenting a study related to an AI/ML device and its performance metrics. The non-clinical tests mentioned (biocompatibility, sterilization validation, reverse engineering analysis) are performed on the physical dental implant abutment and its interaction with implant systems, not on an AI system.

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The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. The OT Equator abutments are indicated for use with the following implant systems: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4.3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brânemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Brånemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Brånemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 - 4.8 Straumann USA - Tissue level RN 4,8 Straumann USA - Tissue level WN 6.5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5. 4.5. 5.7 Zimmer Dental Inc. - Spline 3.25. 3.75 - 4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT LLC - Tri-Lobe 3.5, 4.3, 5 - 6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 - 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75, 4.2, 5, 6 MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75, 3.9, 4.2, 4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4, 4.5, 5, 5.5 NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4, 4.3, 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4, 4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5

The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla. The device is intended for use in healthcare facilities/hospitals.

The sphere OT Equator technology represents a prosthetic abutment solution for "overdenture". The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.

The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any compatible prosthetic restoration.

The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.

This document is a 510(k) premarket notification for the "OT EQUATOR" device, an endosseous dental implant abutment. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance metrics through clinical trials. As such, the information typically found in acceptance criteria and detailed study results for novel devices is not explicitly provided in the same format.

However, based on the provided text, we can infer how the device meets acceptance criteria through its demonstrated substantial equivalence to the predicate.

Here's an analysis of the requested information based on the provided text:

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate device (OT EQUATOR, K142211). The "reported device performance" for the new submission (OT EQUATOR, K160382) is its equivalence to these characteristics.

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

The document primarily relies on non-clinical tests to demonstrate substantial equivalence. For the reverse engineering analysis:

• Sample Size: "a statistically significant number of OEM implant systems" were used. The exact number is not specified.
• Data Provenance: Not explicitly stated, but the company (Rhein'83 SRL) is based in Italy. The testing would have been performed on commercially available implant systems. It is not a clinical study, so terms like retrospective/prospective don't directly apply.

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. This submission concerns a physical device and its material/design characteristics validated against a predicate device and engineering standards, not diagnostic performance requiring expert interpretation of medical images or conditions. The "ground truth" for the non-clinical tests (like reverse engineering) would be the technical specifications of the implants and the device, measured by calibrated instruments, not expert consensus.

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

Not applicable. Adjudication methods are typically used in clinical studies with subjective interpretations. The non-clinical tests described (biocompatibility, sterilization validation, reverse engineering) rely on objective measurements and established 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 device is a dental implant abutment, not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant.

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

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

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

For the non-clinical tests:

• Biocompatibility: Ground truth is established by international standards (e.g., ISO 10993 series, though not explicitly detailed here, it's implied by the reference to "permanent duration (> 30 days), mucosal membranes contacting device").
• Sterilization Validation: Ground truth is established by international standards (e.g., ISO 17664 and ISO 11737-1/-2) for a Sterility Assurance Level (SAL) of 10-6.
• Reverse Engineering Analysis: Ground truth is the precise dimensions and specifications of the compatible OEM implant systems. These are objective engineering measurements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. No training set exists.

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The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

The OT Equator abutments are indicated for use with the implant systems listed in Attachment B.

The OT Equator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial denture retained in whole or in part by endosseous implants in the mandibula or maxilla.

OT Equator technology represents a prosthetic abutment solution for "overdenture". The sphere The emerging profile, specifically designed to accommodate the relative interchangeable copings OT Equator, allows the coupling with a removable prosthesis or "overdenture", which is properly built only if it is properly profiled and based on the patient's gingival arch. Therefore, the removable prosthesis unloads the chewer loads on the natural gum of the intra oral arch, making the OT Equator abutments passive with lacking of solicitation.

The OT Equator is manufactured of titanium Ti-6AI-4V (meets ASTM Standard F-136) and it is designed to retain any prosthetic restoration.

The OT Equator overdenture system is comprised of a semispherical head, a base, and a screw.

The approval of the OT Equator device is based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria from a standalone study. Therefore, the information provided does not contain a table of acceptance criteria and reported device performance in the traditional sense, nor details of a study directly designed to prove the device meets such criteria.

Instead, the submission focuses on non-clinical tests (biocompatibility, mechanical strength, fatigue, sterilization validation, and reverse engineering analysis) to show that the OT Equator is as safe and effective as its predicate devices, despite minor dimensional differences.

Here's an breakdown of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a table of acceptance criteria with corresponding performance metrics like sensitivity/specificity for this type of device (an endosseous dental implant abutment). The regulatory approval is based on demonstrating substantial equivalence. The "performance" is implicitly demonstrated through non-clinical testing that aligns with relevant standards and shows comparable structural integrity and biocompatibility to the predicate device.

"Performance" as demonstrated by Non-Clinical Tests (Implicit Acceptance):

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility: No specific sample size mentioned as no new testing was performed. Reliance on predicate device's prior clearance and material standards.
• Mechanical Strength & Fatigue: The document states "the smallest compatible implant was chosen as worst case" for fatigue testing, and compression tests were run on "various connections." For reverse engineering analysis, "tests were conducted on a statistically significant number of OEM implant systems." Specific numerical sample sizes are not provided for these tests.
• Sterilization Validation: No specific sample size mentioned. Standard validation protocols (ISO 17664, ISO 11737-1/-2) would imply a predetermined sample size based on the specific sterilization method and validation plan.
• Data Provenance: The document does not specify country of origin for the test data, nor whether the tests were retrospective or prospective. It is implied these were prospective tests conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device does not typically involve "ground truth" derived from expert consensus in the clinical sense (e.g., radiologist reads of images). The "ground truth" for non-clinical engineering tests is established by adherence to recognized standards and objective measurements. Experts involved would be engineering and material science professionals carrying out the laboratory tests. Their specific numbers and qualifications are not detailed in this submission.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation scenarios for consensus on diagnoses.

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. The OT Equator is a physical dental implant abutment, not an AI-powered diagnostic device or software. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.

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

Not applicable. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Material Standards: Conformance to ASTM Standard F-136 for titanium.
• Mechanical Testing Standards: Adherence to FDA Guidance Document: "Root-form Endosseous Dental Implants and Endosseous Dental Abutments, 2004" and ISO 14801 standard for dynamic fatigue.
• Sterilization Standards: Conformance to ISO 17664 and ISO 11737-1/-2.
• Objective Engineering Measurements: Dimensions, tolerances, and fit confirmed through various calibrated instruments during reverse engineering analysis.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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