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The INNO SLA Mini Plus® Implant System is divided into two types:

• Cemented Type
  The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors to serve as temporary support prosthetic devices during stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.

• Ball Type
  The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exeed one hundred and eighty (180) days.

The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.

The provided text is a 510(k) summary for the INNO SLA Mini Plus® Implant System, which establishes substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study for performance. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.

However, I can extract the non-clinical performance data and related information as presented.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of acceptance criteria with corresponding device performance metrics from a formal study. Instead, it describes various non-clinical tests conducted or leveraged to demonstrate substantial equivalence to predicate devices. These tests primarily focus on material properties, manufacturing processes, and safety aspects.

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

This information is not provided in the document. The document describes non-clinical tests, and for those, the "sample size" would refer to the number of units tested. This detail is not present. Data provenance (country of origin, retrospective/prospective) is also not applicable or not disclosed for these non-clinical tests.

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

This information is not provided. This document focuses on demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of characteristics, not through a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple readers or assessors, which is not described here.

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 information is not provided. The device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable.

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

This information is not applicable. The device is a physical dental implant system, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility/Chemical Analysis: The ground truth would be established by industry standards and regulatory requirements for safe material interaction with biological systems.
• Sterilization Validation: Ground truth is established by meeting the sterility assurance level (SAL) defined by ISO standards.
• Shelf Life: Ground truth is established by assessing material degradation over time under specific conditions.
• Endotoxin Testing: Ground truth is established by meeting specified pyrogen limits.
• MRI Safety: Ground truth is established by referenced scientific literature and adherence to ASTM standards and FDA guidance for MR safety, which define acceptable parameters for magnetic field interaction, heating, and artifact generation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would have involved a sample size of the physical device components, but these details are not disclosed.

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

This information is not applicable/not provided for the same reason as point 8.

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The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.

The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.

The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).

The provided text is a 510(k) Pre-market Notification for the Hiossen EM SA Implant System. This document asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics. Therefore, it does not contain the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.

Here's an explanation of why the requested information is not available in the provided text:

• 510(k) Pre-market Notification: This regulatory pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics to existing devices, rather than conducting new, comprehensive clinical performance studies to prove superiority or meet novel performance criteria as might be seen for PMA submissions or novel AI devices.
• Medical Device Type: The EM SA Implant System is an endosseous dental implant, which is a physical device made of titanium alloy. The "device" in this context is a physical implant, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," or "sample size for the training set" are not applicable.
• Focus on Equivalence: The document's primary goal is to establish equivalence. It emphasizes that the new device uses the same materials, manufacturing processes, surface treatments, sterilization methods, and has similar designs to predicate devices. This implies that if the predicate devices meet safety and effectiveness standards, the new device, being substantially equivalent, should also.

Based on the provided text, here is what can be extracted or deduced regarding the evaluation process for this specific medical device submission, recognizing that it's not an AI/ML device and thus many questions are not directly applicable:

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

The document does not explicitly state quantitative acceptance criteria or precise performance metrics in the format typically seen for novel device performance studies. Instead, it aims to demonstrate substantial equivalence to predicate devices, implying that its performance is comparable and therefore acceptable.

A summary of the comparison to predicate devices, which serves as the basis for "acceptance" (of equivalence):

The document concludes that the proposed device is "substantially equivalent with respect to the intended use, structure, material, surface, sterilization and design with the legally marketed primary predicate device" and that "The slight difference in thread diameter and length is a simple size addition. The proposed device does not pose any new or increased risks as compared to the legally marketed primary predicate and reference devices."

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

• Test Set Sample Size: Not applicable. No clinical performance testing with a "test set" was submitted for this 510(k) pathway as per the document: "No clinical performance report(s) is being submitted."
• Data Provenance: Not applicable. The submission relies on non-clinical data (biocompatibility, sterilization, shelf life, surface treatment, fatigue testing) which were either reasoned not necessary to re-test due to equivalence to predicates using identical processes and materials, or demonstrated compliance with international standards (e.g., ISO 11137 for sterilization, ISO 11607-1 for shelf life). These are laboratory/engineering tests, not 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. There was no clinical "test set" or requirement for expert-established ground truth mentioned in this 510(k) submission.

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

• Not applicable. No "test set" was used for clinical performance evaluation.

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, not an AI/ML software or system that would involve human "readers" or AI assistance.

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

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

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

• Not applicable in the clinical trial sense. The "ground truth" for this submission revolves around established engineering and material science standards. For example:
  • Biocompatibility: Established by demonstrating the use of identical manufacturing processes and materials (titanium alloy Ti-6Al-4V, ASTM F 136) as the predicate device, which is a "well known and well established material." Compliance with ISO 10993 (Biological Evaluation of Medical Devices) is implied through equivalence.
  • Sterilization Validation: Established by demonstrating identity to the predicate device in manufacturing process, material, sterile barrier system, and use of gamma radiation under the same conditions, validated following ISO 11137.
  • Shelf Life: Established by demonstrating identical packaging materials & methods as a reference device (Hiossen Implant System, K140934) which had an 8-year shelf life validated per ISO 11607-1, and stating the device is medical grade titanium, non-mechanical, non-active.
  • Surface Treatment Characterization: Established by demonstrating identical manufacturing process, material, and SA (Sandblasted, Acid etched) surface treatment as the predicate device.
  • Fatigue Testing: Established by demonstrating identical manufacturing process, material, and "very similar design" to a predicate device (MS SA) that was fatigue tested in accordance with ISO 14801:2003.

8. The sample size for the training set

• Not applicable. This device is a physical implant; there is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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