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BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.

However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.

Here's the summary based on the provided document:

Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)

The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
• Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.

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

• This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical submission for a physical medical device.

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 physical dental implant system, not an AI/ML device, so no MRMC study was performed.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for establishing device performance in this context is derived from:
  • Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
  • Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
  • Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable.

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The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (ZLA® surface). The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant (Monotype) prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).

The temporary copings are manufactured from polymethylmethacrylate (PMMA).

This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.

Let's break down what information is available based on your request and what is not available for a device like this.

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

For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.

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 (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
• Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.

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 section is not applicable to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.

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

This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.

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 section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.

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

This section is not applicable. This is not an AI algorithm.

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

• Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.

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

This section is not applicable for the same reason as point 8.

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The Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.

The Stern AC Dental Implant System is only intended for use with straight abutments.

The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.

The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:

Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798

They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.

The provided document is a 510(k) Premarket Notification for the Stern AC Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or quantifiable performance metrics for the Stern AC Dental Implant System. Instead, the "performance" demonstrated is that the device is "substantially equivalent" to predicate devices and "performs appropriately for the proposed indications for use." The performance testing mentioned is primarily non-clinical, focusing on material and design characteristics.

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

• Test Set Sample Size: Not applicable in the context of this document. The submission is based on demonstrating substantial equivalence through comparison of design, materials, and non-clinical performance to existing cleared devices, not on a clinical "test set" of patients or a defined dataset with ground truth for algorithm evaluation.
• Data Provenance: The data provided primarily stems from the manufacturer's internal design specifications, material characterization, manufacturing process descriptions, and comparisons to predicate devices. It is entirely retrospective in the sense that it relies on existing knowledge and data for predicate devices and internal validation of the manufacturing processes and material properties of the new device. There is no mention of patient data, clinical trials, or external datasets.

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

• Not applicable. There is no "test set" in the sense of a dataset requiring expert ground truth establishment for algorithm evaluation. The "ground truth" for this submission is FDA's existing clearances for predicate devices and established standards for dental implant materials and design.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" requiring adjudication.

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 document describes a traditional medical device (dental implant) submission, not an AI/software as a medical device (SaMD) submission. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" in this context is established by:
  • Regulatory Precedent: The FDA's previous clearance of the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798)).
  • Industry Standards: Adherence to guidance documents like "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."
  • Material Science Principles: The properties of CP Titanium grade 4 and the known performance of specific surface treatments (blasted with aluminum oxide particles and acid etched).
  • Engineering Design Principles: The design features like self-tapping threads, flared neck, and internal connections are evaluated against known engineering principles for dental implants.
  • Laboratory Testing: SEM photographs for blasting residue removal and sterilization validation results.

8. The Sample Size for the Training Set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no "training set" or ground truth for such a set.

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The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. The Stern IC Dental Implant System is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern IC Dental Implants are compatible with the Straumann Rn Synocta , Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, and the Straumann RC Cementable abutments. The Stern IC Dental Implant System is only intended for use with straight abutments.

The Stern IC Dental device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters. This submission also includes healing abutments, solid abutments, and cover screws which are used as accessories to the dental implants. The implant components are manufactured from pure, implant-grade titanium alloy and are equivalent in terms of materials, performance specifications, manufacturing, manufacturing equipment, packaging materials and design as other Sterngold abutments and cover screws previously approved via K892124 and K924219. The Stern IC Dental Implants and abutments are compatible with the Straumann Rn Synocta (K073628), Straumann SynOcta Meso Abutments (K033243), Straumann RC Temporary Abutments, (K093027) and the Straumann RC Cementable abutments (K072071). The Stern IC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments. The proposed Stern IC Dental Implant will be available in a range of lengths and diameters.

"The provided text does not contain information about studies related to AI/ML device performance or acceptance criteria in the typical sense for such devices. The document is a 510(k) summary for a dental implant system (Stern IC Dental Implant System).

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This document
   focuses on substantial equivalence to predicate devices, not performance criteria
   against a defined benchmark.
2. Sample size used for the test set and the data provenance: Not applicable as
   there is no discussion of a test set for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the
   qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was
   done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data,
   etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document details the substantial equivalence of the Stern IC Dental Implant
System to predicate devices based on material, design, surface treatment, and intended
use. The study described is a non-clinical testing to demonstrate appropriate
performance for the proposed indications for use, following "Guidance for Industry and
FDA Staff - Class 11 Special Controls Guidance Document: Root-form Endosseous Dental
Implants and Endosseous Dental Abutments."

Specifically, the non-clinical testing involved:

• SEM photographs: To show removal of all residue of the blasting material from the surface.
• Surface chemical analysis: To confirm no contaminants are left on the surface (conducted on the final device).

It states that fatigue testing was not required because design and technological features are substantially equivalent to predicate devices. The conclusion is based on an analysis of intended use, material, design, and performance being substantially equivalent to the predicate devices (Sterngold Acid Etch Dental Implant System (K023580) and Straumann ITI Dental Implant System (K012757))."

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