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The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The provided document is a 510(k) summary for the DIO SM Implant System, which is a dental implant device. It details a modification to a previously cleared device. However, the document does not contain information about acceptance criteria, device performance, specific studies with sample sizes, expert ground truth establishment, or any AI-related data as requested.

The submission is focused on demonstrating substantial equivalence to a predicate device (SM Implant System, K061797) based on material, design, intended use, and other technological characteristics. The performance section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This suggests bench testing, but no specific results or acceptance criteria are provided in the public summary.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, expert involvement, or AI performance, as this information is not present in the provided text.

The document mainly focuses on:

• Device Identification: Submitter, device name, classification.
• Predicate Device: Identification and comparison tables demonstrating substantial equivalence.
• Intended Use: Description of how the device is used.
• Regulatory Information: 510(k) number, FDA review and approval.

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Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients

Sccure Implant System(2.5/3.0mm) is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.5 and 3.0mm, and lengths from 8mm to 16mm.

The provided text describes a 510(k) submission for the "Secure Implant System (2.5/3.0mm)", which is an endosseous dental implant system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving efficacy through clinical studies with acceptance criteria and device performance metrics in the way a new drug or novel medical device might.

Therefore, the document does not contain information on:

• Acceptance criteria tables with reported device performance: This submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than meeting specific performance metrics derived from a clinical study.
• Sample sizes used for a test set or data provenance
• Number or qualifications of experts for ground truth establishment
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm-only) performance
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

The study section of the document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that testing was performed internally by the manufacturer to ensure the device met its design specifications and performed as intended, which is standard for medical device development. However, specifics of this laboratory testing (e.g., acceptance criteria, test results) are not detailed in the provided 510(k) summary.

The primary method for demonstrating "device meets acceptance criteria" in this context is through substantial equivalence to predicate devices. The table provided in Section 14-12, "Substantial Equivalence Comparison," outlines the characteristics of the subject device (Secure Implant System) against two predicate devices (IntermezzoTM Plus and Zimmer One-Piece Implant System, though only IntermezzoTM Plus is detailed in the table). This comparison acts as the "study" proving the device's acceptability by showing it is similar enough to already-approved devices, rather than a clinical trial with specific performance metrics.

Summary of available information:

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The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.

The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Ø 3.8mm, Ø 4.1mm, Ø 4.5mm, Ø 4.8mm, Ø 5.3mm. Length: 8.0mm, 10.mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A~STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO42H2O). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon a biomimetic process in which implants are coated in an electrolytic bath with a 15+/- 5um thin bioactive layer of a calcium phosphate composite. Biotite -- H Implant System composed of the two calciumphosphates brushite(>95% )and HA(

Here's an analysis of the provided text regarding the DIO Biotite-H Implant Systems:

Acceptance Criteria and Study for DIO Biotite-H Implant Systems

The provided 510(k) summary for the DIO Biotite-H Implant Systems indicates that the device's performance was evaluated through laboratory testing to determine functionality and conformance to design input requirements. However, the document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., accuracy, sensitivity, specificity, or failure rates). Instead, the primary "acceptance criteria" appear to be focused on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.

The study presented is a substantial equivalence comparison rather than a traditional clinical or performance study with defined numerical acceptance criteria for device efficacy or safety. The document aims to show that the new device is as safe and effective as previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for performance are not provided. The "reported device performance" is essentially a statement of comparability to the predicate device in several key aspects.

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SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.

SM-Extra Wide(RBM) Implant System consists of SM-Extra Wide(RBM) fixtures, abutments, prosthetics and surgical instruments.

SM-Extra Wide(RBM) Implant Fixtures are made of commercial pure titanium, grade 4 which have a sand-blasted, RBM(Resorbable Blast Media) treated surface. These fixtures are the onestage implant and two-stage implant and surgically inserted in the maxillary or mandibular molar areas or where smaller implants have failed.

These fixtures are the integrated system of endosseous dental implants which designed to Provide prosthetics support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals.

The screw, cemented and overdenture retained restoration, other superstructure and instruments for prosthetics that used when the SM-Extra Wide implants is surged are same with each standard type of DIO SM Implant System.

This submission, K080128, for the SM-Extra Wide(RBM) Implant System, does not describe an AI/ML powered device. Instead, it is a traditional 510(k) submission for a dental implant system. As such, the information you've requested regarding acceptance criteria and studies proving the device meets those criteria, particularly with reference to AI/ML specific performance metrics, is not present in the provided text.

The submission focuses on establishing substantial equivalence to a predicate device (Rescue Internal Dental Implant System, K063216) based on technological characteristics and intended use.

Here's an analysis of the provided text in relation to your questions, highlighting why most AI/ML-specific questions are not applicable:

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

• Acceptance Criteria: The document implies acceptance criteria are based on device functionality and conformance to design input requirements, as stated in section 8: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, specific numerical acceptance criteria (e.g., success rates, torque values, fatigue limits) for these "design input requirements" are not explicitly listed in the provided text.
• Reported Device Performance: The primary "performance" reported is the demonstration of substantial equivalence to the predicate device. This is shown through a direct comparison of technological characteristics in Section 12. No quantitative performance data from clinical trials or specific laboratory tests (beyond the general statement above) are provided or summarized.

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

• This information is not applicable as this is a physical medical device (dental implant) and not an AI/ML algorithm or software that operates on data. The "testing" mentioned is laboratory testing of the physical implant's functionality, not a test set of 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)

• This is not applicable. Ground truth, in the context of expert consensus, is relevant for evaluating the performance of diagnostic or prognostic AI/ML models. For a physical dental implant, "ground truth" would be established through established engineering and biocompatibility standards, not expert adjudication of a test set.

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

• This is not applicable. Adjudication methods are used in studies involving human interpretation or consensus for data labeling/ground truth in AI/ML 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

• This is not applicable. MRMC studies are specific to evaluating diagnostic systems, particularly imaging devices or AI tools, and their impact on human reader performance. This submission is for a physical implant.

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

• This is not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

• For the performance of this physical implant, the "ground truth" implicitly relies on engineering standards, material science properties, biocompatibility testing (which may involve in-vitro or animal studies, though not detailed here), and successful historical clinical use of physically similar predicate devices. No explicit "ground truth" of the types listed (expert consensus, pathology, outcomes data) for a data-driven evaluation is mentioned.

8. The sample size for the training set

• This is not applicable. There is no AI/ML algorithm being "trained" in this submission.

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

• This is not applicable. There is no AI/ML algorithm being "trained" in this submission.

In summary, the K080128 submission is a standard 510(k) for a physical medical device, demonstrating substantial equivalence to a predicate. The questions posed are primarily relevant to AI/ML powered devices, which this product is not.

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The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for restorations.

The provided text describes a 510(k) premarket notification for the DIO Implant Systems, a dental implant device. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device.

The "Performance" section (14-8) states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, it does not provide details about the specific acceptance criteria, method, sample size, or results of this laboratory testing.

The document primarily focuses on establishing substantial equivalence to a predicate device (SM® IMPLANT SYSTEMS) based on intended use, material, design, and technological characteristics.

Therefore, I cannot fulfill your request for the tables and detailed study information as the provided text lacks the necessary content for acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert-related information for an AI/ML device.

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The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

DIO Protem Implant System consists of Protem Implants, Superstructure, Prosthetics and Surgical Instruments. The Protem Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm). The superstructures consist of Protem Cemented Abutment, Ball Cap and Healing Cap. The Protem Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion of fixture. The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation. The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.

The provided text describes a 510(k) premarket notification for the "DIO Protem Implant System (2.0/2.5mm)". This submission is for a medical device (endosseous dental implant system) and not for an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC) and associated studies (MRMC, standalone, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods) is not applicable here.

Instead, the "acceptance criteria" for a medical device like this in a 510(k) submission typically revolves around demonstrating substantial equivalence to a previously legally marketed predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to performance testing (bench testing) and a thorough comparison against the predicate device to show that the new device is as safe and effective.

Here's how to interpret the information provided in the context of a traditional medical device 510(k) submission:

Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The "acceptance criteria" for the DIO Protem Implant System (2.0/2.5mm) is demonstrating substantial equivalence (SE) to its predicate device, the DIO Protem Implant System (K06710568). This is the primary criterion for clearance under a 510(k).

The "study" or evidence provided to prove the device meets this acceptance criterion is a substantive comparison of its technological characteristics and intended use to the predicate device, supported by laboratory testing.

1. Table of Acceptance Criteria and the Reported Device Performance (interpreted for medical devices, not AI):

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

Not applicable for this type of medical device submission. The evaluation relies on the physical and material characteristics of the device, as well as bench testing to verify performance, rather than a "test set" of patient data.

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 AI/ML device performance is not relevant here.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established by engineering specifications, material science standards, and performance test results. For instance, the stated dimensions (e.g., diameter, length) are verified directly against engineering drawings and manufacturing tolerances.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm being "trained."

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

Not applicable.

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The SM Dental implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

SM® Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.

The provided text describes a 510(k) summary for the SM® Internal/External Implant Systems. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The information presented is typical for a medical device submission seeking regulatory clearance, focusing on comparison to existing devices rather than a detailed performance study with acceptance criteria and statistical analysis in the way modern AI/ML device submissions require.

Therefore, many of the requested elements for a performance study evaluating an AI/ML device will not be present in this document, as it pertains to a dental implant system.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of an AI/ML device validation. The "Performance" section generically states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This likely refers to mechanical, material, and biocompatibility testing inherent to dental implants, not a data-driven validation. No specific sample sizes for such tests are provided in this summary, nor is the provenance of any "data" specified. It is a physical device, and testing would involve physical specimens, not a data set.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device with a test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This document pertains to a physical dental implant, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as used in AI/ML validation (e.g., pathology, outcomes data) is not applicable here. For this physical device, the "ground truth" would be established by validated engineering standards (e.g., ASTM-F-67 for materials), mechanical testing benchmarks (e.g., fatigue strength, torque), and biocompatibility assessments, which are not detailed in this summary. The submission focuses on demonstrating "substantial equivalence" to a predicate device based on identical materials, similar design, and intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and therefore, 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 an AI/ML model, there's no ground truth establishment for it.

Summary of the Study and Device Performance:

The provided 510(k) summary for the SM® Internal/External Implant Systems describes a submission to the FDA seeking clearance for a dental implant. The primary method for proving the device meets acceptance criteria is through demonstration of substantial equivalence to a previously cleared predicate device (SM® Implant System, K061797).

The study that supports the device meeting its acceptance criteria is not a "study" in the sense of a clinical trial or AI/ML validation. Instead, it relies on a comparison of technological characteristics and intended use to the predicate device, along with "Laboratory testing... to determine device functionality and conformance to design input requirements."

The acceptance criteria are implicitly met by showing that:

• The Intended Use is "Identical to predicate devices."
• The Material (Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)) is identical.
• The Technological Characteristics such as design (Morse Taper with Thread), screw threads (YES), implant thread diameter (3.8, 4.5, and 5.3 mm), collar height (1.8 mm), lengths (8-14 mm), surface treatment (Machined), and sterilization (Gamma sterilized) are identical to or within the established parameters of the predicate device.
• The types of Attachments supported are also identical.

The "reported device performance" is the direct correspondence and equivalency of these characteristics to the predicate device. The FDA's letter of clearance (K070569) signifies that the agency has reviewed this comparative information and determined the device is "substantially equivalent" to the predicate, thus deeming its performance acceptable for market entry based on the predicate's established safety and effectiveness. Specific quantitative results from the "laboratory testing" are not detailed in this summary.

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The DIO Protem Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

DIO Protem Implant System is a root-form threaded dental implant made of titanium alloy. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 2.0 and 2.5mm, and lengths from 8mm to 14mm. It is placed via one stage surgery and the functional loading can be from immediate to delay.

The provided 510(k) submission for the DIO Protem Implant System (K070568) does not contain information regarding objective acceptance criteria, a specific study proving the device meets those criteria, or details of a clinical performance study.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Mega'Gen Co., Ltd. Intermezzo ™ Implant System, K051018) through comparative analysis of technological characteristics and intended use. The performance section explicitly states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates a focus on engineering specifications rather than a clinical performance study with predefined acceptance criteria for clinical outcomes.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

• No specific acceptance criteria for clinical performance are mentioned.
• No reported clinical device performance is detailed in this document. The submission only mentions that "laboratory testing was conducted to determine device functionality and conformance to design input requirements." This likely refers to mechanical or material testing, not clinical outcomes.

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

• Not applicable. The document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy or clinical outcomes. The "laboratory testing" mentioned does not provide details on sample size or data provenance.

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

• Not applicable. No clinical ground truth establishment is described in this submission.

4. Adjudication method for the test set

• Not applicable. No clinical ground truth establishment or adjudication is described in this submission.

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

• No MRMC comparative effectiveness study was done. This device is a dental implant, not an AI-powered diagnostic tool.

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

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

7. The type of ground truth used

• Not applicable for clinical performance. For the substantial equivalence claim, the "ground truth" implicitly relies on the safety and effectiveness of the predicate device. For the laboratory testing, the ground truth would be the engineering design input requirements.

8. The sample size for the training set

• Not applicable. This device is a dental implant; there is no "training set" in the context of machine learning or AI.

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

• Not applicable.

Summary of what the submission does say about "performance":

The submission states:

• "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (Section 13-8. Performance)
• The overall strategy for regulatory clearance is Substantial Equivalence to the Mega'Gen Co., Ltd. Intermezzo ™ Implant System (K051018). The substantial equivalence comparison table focuses on:
  • Intended Use (Identical to predicate)
  • Material (Titanium alloy vs. Commercially pure titanium GR. 3)
  • Screw Threads (YES for both)
  • Implant Thread Diameter (2.0 and 2.5 mm vs. 1.6, 2.0, 2.5, 3.1 mm)
  • Lengths (8-14 mm vs. 10.0, 13.0, 15.0 mm)
  • Surface Treatment (Machined for both)
  • Sterilized (YES for both)

To receive 510(k) clearance, the manufacturer demonstrates that the new device is as safe and effective as a legally marketed device (the predicate). For devices like this dental implant, the "performance" demonstrated for substantial equivalence often involves showing that material properties, mechanical strength, biocompatibility, and manufacturing processes are comparable to the predicate, and that the intended use is the same or very similar. This typically relies on engineering and biological testing, rather than extensive clinical efficacy trials with specific clinical acceptance criteria.

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The SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The SM Implant System is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5, and 5.3 mm, and lengths from 8mm to 14 mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.

The provided text describes a 510(k) premarket notification for the "SM Implant Systems" (K061797), an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics typically found in efficacy studies for novel devices.

Therefore, the input document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9. The document explicitly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" (Section 13-8. Performance), but it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for device performance.

The 510(k) summary (and the FDA's response letter) confirms that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and a study proving those criteria were met.

Summary of what is possible to extract from the provided text:

• Device Name: SM Implant Systems
• Classification Name: Endosseous Dental Implant System
• Predicate Device: ANKYLOS® DENTAL IMPLANT SYSTEM (K012087)
• Performance information: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No details provided)
• Type of Study (implied by 510(k)): Substantial equivalence determination based on comparison to a predicate device, supported by laboratory testing for functionality and conformance to design requirements. This is not a clinical efficacy study with acceptance criteria as requested in the prompt.

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