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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All digitally-designed custom abutments for use with Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K221453, K222231, K211921, K193096, and K170392.

This submission adds Pre-Milled CAD-CAM Abutments to the S.I.N. Dental Implant System. The subject device abutments are provided with 11.5° CM and 16° CM connections compatible with the above S.I.N. dental implants.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are the same for the 11.5° CM implant connection and the 16° CM implant connection. The design limit parameters are:

Minimum wall thickness - 0.55 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.55 mm Maximum gingival height - 3.5 mm Minimum prosthetic platform diameter - 3.5 mm Maximum prosthetic post height - 6 mm Maximum angulation - 30°

The subject device abutments are compatible with previously cleared S.I.N. Dental Implant bodies summarized in the following table.

All subject device abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136, and are to be used with compatible abutment screws previously cleared in K170392. All subject device abutments are provided non-sterile and are to be moist heat sterilized by the end user.

This document describes the regulatory clearance for the S.I.N. Dental Implant System, specifically focusing on the addition of Pre-Milled CAD-CAM Abutments. This is a 510(k) submission, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, sample sizes for test sets, ground truth establishment by experts, MRMC studies, and training sets, is not applicable to this type of regulatory submission.

Here's why and what information is provided in the document related to "acceptance criteria" from a substantial equivalence perspective:

In a 510(k) submission for a device like this, "acceptance criteria" are primarily met through non-clinical performance data demonstrating that the new device (the subject device with the added components) is as safe and effective as the predicate device(s). The "study" proving this typically involves engineering analyses and bench testing, comparing the subject device to the predicate device(s) or established standards.

Detailed breakdown based on the provided document:

1. Table of Acceptance Criteria (from a Substantial Equivalence Perspective) and Reported Device Performance:

The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device has the same intended use and similar technological characteristics as the predicates and that any differences do not raise new questions of safety or effectiveness. The reported performance is shown through the non-clinical tests.

This statement is identical to the primary predicate device (K193096) for the core indications, and similar to reference devices with minor differences that are addressed (e.g., specific implant lengths not relevant to the subject device, or predicate not explicitly mentioning CAD-CAM abutments which is addressed by K193096). |
| Technological Characteristics Equivalence | Abutment Design Parameters: The design parameters for the CAD-CAM fabrication of patient-specific abutments from Pre-Milled CAD-CAM Abutments are provided (Minimum wall thickness - 0.55 mm, Minimum post height for single-unit restoration - 4.0 mm, Minimum gingival height - 0.55 mm, Maximum gingival height - 3.5 mm, Minimum prosthetic platform diameter - 3.5 mm, Maximum prosthetic post height - 6 mm, Maximum angulation - 30°). These parameters are compared to those of predicate abutments (e.g., Abutment Cemented Angled Indexed SIT with CM 11.5° interface and Abutment Cemented Morse Angled with CM 16° interface).

Material: Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, same as predicate devices.

Sterilization Method: Non-sterile, to be moist heat sterilized by end-user. Validation performed to a sterility assurance level of 10^-5 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2. Similar to some predicate devices.

Biocompatibility: Referenced from K170398 for abutment material ASTM F136 (ISO 10993-5 cytotoxicity).

MR Safety: Referenced from K221453 (ASTM F2052, F2213, F2182, F2119, and FDA guidance).

Mechanical Performance: Engineering analysis provided to demonstrate that the subject device abutments, in combination with compatible previously cleared dental implants, do not create a new worst-case construct in terms of mechanical testing according to ISO 14801. Mechanical testing data were referenced from K200992 conducted according to ISO 14801. |
| Safety and Effectiveness Equivalence (absence of new risks)| An engineering rationale was provided to demonstrate that the use of the subject device abutments in combination with the compatible implants raise no new risks and that mechanical testing data provided in a prior submission (K200992) are applicable to the subject abutments. The non-clinical performance data (sterilization, biocompatibility, MR safety, mechanical) supports this. |

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

• Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for this 510(k). The "test set" here refers to the samples of the device and implant components used for bench testing (e.g., mechanical testing, sterility validation). The document indicates mechanical testing was done per ISO 14801, which would have defined the number of samples required for that specific test, but the exact number isn't provided in this summary.
• Data Provenance: The manufacturing entity, S.I.N. - Sistema de Implante Nacional S.A., is based in São Paulo, Brazil. The testing would typically be performed either in-house by the manufacturer or by contract research organizations (CROs) in a relevant country. The document does not specify the country where the non-clinical tests (e.g., mechanical, sterilization validation) were explicitly conducted. These non-clinical tests are prospective, meaning they are performed specifically to support the submission.

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 device clearance is based on non-clinical performance data (bench testing, engineering analysis) and substantial equivalence to predicate devices, not on human interpretation or diagnosis. Therefore, there is no "ground truth" established by medical experts in the way it would be for an AI diagnostic device.

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

• Not Applicable. As no expert review or clinical trial data requiring adjudication was performed, this concept is irrelevant to this 510(k) 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. This is not an AI/software as a medical device (SaMD) and no MRMC study was conducted or is required for this type of implant device.

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

• Not Applicable. This is a physical dental implant system, not a software algorithm.

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

• For this 510(k) submission, the "ground truth" for demonstrating device performance is typically established by:
  • International Standards: e.g., ISO 14801 for mechanical testing of dental implants, ISO 10993 for biocompatibility, ISO 17665 for sterilization. These standards provide accepted methodologies and performance requirements.
  • Engineering Principles and Analyses: Demonstrating that the new components, when combined with existing cleared components, do not introduce new failure modes or decrease mechanical integrity compared to the predicate.
  • Comparison to Predicate Devices: Showing that the subject device's characteristics (design, material, intended use) are sufficiently similar to legally marketed devices.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning/AI device, 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, this question is not relevant.

In summary: The provided document is a 510(k) clearance letter for a dental implant system, a physical medical device. The "acceptance criteria" and "proof" are demonstrated through extensive non-clinical (bench) testing and engineering analyses to show substantial equivalence to predicate devices and adherence to relevant industry standards, rather than clinical trials involving human subjects or AI algorithm performance metrics.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implant System implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.-validated milling center for manufacture.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K203725, K200992, K193096, K170398, and K051859.

This submission includes dental implants Epikut CM with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut Plus CM implants with an endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA ""0"). The implant design and endosseous surfaces are identical to those cleared in K211921, with the exception of the additional body/platform diameter (4.0 mm) and the longer lengths (18, 20, 22, and 24 mm).

This submission includes Multifunctional Abutments with Morse taper connections (16°, 11.5°, and 4°), and protectors and temporary cylinders for these abutments; the subject device Multifunctional Abutments are compatible with subject device implants (CM 11.5°) and previously-cleared implants (CM 16° and 4°). This submission also includes Multifunctional Abutment components (cylinders) manufactured from Co-Cr-Mo alloy compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; CAD-CAM abutment components (called "Interface") manufactured from Ti-6A1-4V alloy and Co-Cr-Mo alloy, compatible with the subject Multifunctional Abutments and with abutments cleared in K170392; and screws compatible with subject device components and previously cleared components with the 11.5° Morse taper connection. All subject device abutments are straight, with no angulation allowed.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K211921, and the HAM00 surface treatment is identical to that cleared in K211921.

The subject device implants are compatible with abutments and prosthetic components in this submission and components cleared previously in K200992, K193096, K170392, and K051859.

The subject device abutments and prosthetic components are compatible with implants and components in this submission and components cleared previously in K211921. K200992. K193096, and K170392.

This document is a 510(k) Premarket Notification for the S.I.N. Dental Implant System. It does not describe an acceptance criteria or a study proving device performance against an acceptance criteria in the way typically found for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to previously cleared predicate devices through non-clinical performance data and detailed comparisons of technological characteristics.

Therefore, the requested information elements related to acceptance criteria, specific study designs (test sets, training sets, expert review, MRMC studies, standalone performance), and ground truth establishment are not applicable to this type of submission.

The document focuses on showing that the new components (implants and abutments) of the S.I.N. Dental Implant System are as safe and effective as existing legally marketed predicate devices. This involves demonstrating equivalency in:

• Intended Use: The indications for use are substantially equivalent to the predicate devices.
• Technological Characteristics: Materials, manufacturing processes, design principles, sterilization methods, and performance data (non-clinical) are comparable or identical.

Here's a breakdown of the requested information based on the provided document, highlighting why most are not directly present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table, with specific numerical acceptance criteria and a corresponding performance metric for an AI device, is not present because this is a 510(k) for a physical medical device (dental implants and components) and not an AI/ML software. The "performance data" provided are non-clinical tests demonstrating material properties, sterilization efficacy, biocompatibility, and mechanical integrity, which are described qualitatively or by reference to established standards (e.g., ISO, ASTM).

Here's an illustrative table based on the provided "PERFORMANCE DATA" section, but it does not represent AI/ML acceptance criteria:

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Align anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterior cages are intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Align 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Align 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one superior screw trajectory. If the physician chooses to use Align anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional spinal fixation system cleared for use in the lumbosacral spine must be used.

Align anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align lateral cages are intended for use at either one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align implants are intervertebral body fusion devices intended for lumbar interbody fusion using an anterior lumbar interbody fusion surgical approach (ALIF), anterolateral (i.e., oblique) lumbar interbody fusion surgical approach (OLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Align constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). Components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile. Align devices are available in six configurations: modular constructs, standard constructs, fully round ALIF (FRA) constructs, and open constructs for ALIF approach, anterolateral (i.e., oblique) constructs for OLIF approach, and lateral constructs for LLIF approach. Align cages are secured on the vertebral bodies using bone screws. A cover plate assembly prevents the screws from backing out after insertion. The cages and cover plates are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Alulminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screws and cover plate screws are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All constructs are zero profile, reducing potential for vessel interference with the anterior column. With the exception of the modular constructs, all cages and bone screws are also available with a hydroxyapatite coating.

The provided text is related to a 510(k) premarket notification for a medical device called "Align" by Acuity Surgical Devices, LLC. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that no clinical data was provided to demonstrate substantial equivalence. This means there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not part of this 510(k submission. The submission relies on non-clinical testing and substantial equivalence to a predicate device and reference devices to demonstrate safety and effectiveness.

Here’s what I can extract based on the document:

1. A table of acceptance criteria and the reported device performance:
Not applicable as no clinical acceptance criteria or performance study results are provided. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical study with a test set is described. Non-clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study with adjudication is described.

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 device is an intervertebral body fusion device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical study requiring a ground truth is described.

8. The sample size for the training set:
Not applicable as no clinical study or AI model with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model with a training set and ground truth establishment is described.

Summary of Non-Clinical Testing (as provided in the document):

The device's substantial equivalence is supported by non-clinical testing, which includes:

• Performance testing per ASTM F2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, and Dynamic Compression Shear.
• Performance testing per ASTM F2267 for Subsidence and Expulsion testing.
  • Note: These tests performed on the predicate device (K201671) are deemed applicable to the modified devices because there is no difference in size, dimension, raw material, or manufacturing method/equipment, except for a nanometer-thin layer of hydroxyapatite applied to the surface.
• Performance testing of HA®® Surface integrity was conducted per the Promimic protocol, which was accepted by FDA for the clearance of reference devices K201614, K170392, and K101225.
• Performance testing of the break-off cover plate screw per the protocol accepted by FDA for the clearance of the reference device K130958.

The document concludes that these non-clinical tests indicate that "Align" is substantially equivalent to the predicate and reference devices.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

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

• Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

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

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing.

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. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This is not applicable as the device is a physical dental implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

• Biocompatibility: Conformance with ISO 10993-1.
• Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
• Sterilization Validation: Conformance with ISO 11137 series.
• Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants: These implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.

This document is a 510(k) Premarket Notification from the FDA, determining substantial equivalence for a dental implant system. As such, it does not contain information about a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for a novel device or software. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics.

Therefore, many of your requested points related to acceptance criteria for a study proving performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable here. This document leverages existing predicate devices and non-clinical testing to argue that the new, shorter versions of the implant are safe and effective.

Here's a breakdown of the information that is available or implicitly addressed, and what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission doesn't present a table of acceptance criteria and performance results in the context of a "study proving the device meets criteria" as one might expect for a new AI or diagnostic device. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (K151391 as primary, K133049 and K170392 as reference devices) through a comparison of technological characteristics and non-clinical testing.

The "acceptance criteria" here are implicitly that the new device configuration (shorter lengths of existing implants) should be as safe and effective as the predicate devices, as demonstrated by:

• Identical Indications for Use
• Identical Operating Principle
• Identical Materials
• Identical Surface Treatment
• Identical Shelf Life
• Identical Packaging and Sterilization materials and processes
• Compliance with relevant ISO standards and FDA guidance for non-clinical testing.

The "reported device performance" is not expressed in measured outcomes against specific clinical performance thresholds, but rather in the statement of "substantial equivalence" based on the comparisons provided.

Relevant Data from Tables 5-3 and 5-4, representing the "performance" by demonstrating similarity to predicates:

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set with patient data. The "tests" are non-clinical (biocompatibility, corrosion, fatigue, comparative area analyses, sterilization, packaging, endotoxin). The sample sizes for these engineering bench tests are not specified in the summary document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data or patient data is mentioned or used for proving substantial equivalence of these specific design changes. The data provenance would be from the B.T.I. Biotechnology Institute, S.L. in Spain (the submitter) for the non-clinical testing performed.

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

• Not applicable. This submission relies on non-clinical engineering and biological testing, not on human expert review of clinical cases to establish ground truth for a test set. Substantial equivalence is determined by the FDA reviewing the provided engineering, material, and performance data against established predicate devices and standards.

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

• Not applicable. No expert adjudication of a test set occurred.

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. This is a dental implant (physical device), not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted.

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

• Not applicable. This 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 sense of clinical ground truth. For a physical device like a dental implant seeking substantial equivalence for a dimension change, the "ground truth" for the non-clinical testing performed (biocompatibility, fatigue, etc.) is the adherence to material specifications (e.g., Titanium CP4), compliance with established international standards (ISO 10993-1, ISO 14801, ISO 11137-1/2, ISO 17665-1/2, ANSI/AAMI ST72), and the established safety and performance profile of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

In summary, this FDA 510(k) clearance is based on demonstrating substantial equivalence of new, shorter versions of an existing dental implant system to established predicate devices through a comprehensive battery of non-clinical (bench) testing and comparison of physical and material characteristics, rather than through new clinical trials or performance studies against specific acceptance criteria for a novel device or software.

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Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.

The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).

The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

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 any of the non-clinical tests.
• Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.

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

• Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. There was no test set for clinical performance 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. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This product is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.

8. The Sample Size for the Training Set

• Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.

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

• Not applicable. There was no training set.

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Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants. The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used. The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.

This document is a 510(k) Pre-Market Notification from the FDA for a dental implant system. It focuses on demonstrating the substantial equivalence of the "Implacil Implant System" to existing legally marketed devices, rather than presenting a study to prove acceptance criteria for a new device's performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study are not fully available or directly applicable to this type of regulatory submission.

However, I can extract the information that is present in the document that relates to performance and equivalence:

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

The document does not present specific acceptance criteria in the typical format of a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, it demonstrates "substantial equivalence" to predicate devices based on shared technological characteristics and mechanical performance.

Differences and Discussion

• Design - presence of chambers: The subject device has chambers on its external surface, while the primary predicate does not. The document states this difference does not alter the external surface area with bone and expects no impact on mechanical performance. This is acknowledged as a "Difference" but mitigated by an analysis.
• Implant diameter/lengths: The subject device's range of diameters and lengths is within the range of dimensions of the primary predicate and reference devices, leading to an "Equivalent" determination.

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. This submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) and does not involve a new clinical or laboratory "test set" for a performance study.
• Data Provenance: Not applicable for a new performance study. The data referenced is primarily existing regulatory clearances and standards.

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. Ground truth establishment by experts for a test set is not part of a substantial equivalence claim for a dental implant's mechanical properties, as opposed to, for example, an AI diagnostic device. The FDA reviewers and the submitters are the "experts" in assessing regulatory compliance and technical equivalence.

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

• Not applicable. Adjudication methods are not used in this type of 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

• Not applicable. This is not an AI/software device; it's a physical dental implant.

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

• Not applicable. This is not an AI/software device.

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

• Ground Truth: For a physical medical device like this, the "ground truth" for its safety and effectiveness is established through adherence to recognized performance standards (e.g., ISO 14801 for dynamic fatigue testing), biocompatibility testing, material specifications (e.g., ASTM F67), and comparability to predicate devices with a history of safe and effective use. The "truth" is based on established engineering principles, material science, and regulatory precedent.

8. The sample size for the training set

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

Study Proving Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which demonstrates substantial equivalence to legally marketed predicate devices. The document explicitly states:

• "Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024." (K183024 is the primary predicate device).
• "No clinical data were included in this submission."

This means that the device meets implied "acceptance criteria" by showing that its materials, manufacturing processes, intended use, and relevant performance characteristics (like mechanical strength assessed via ISO 14801) are either identical or acceptably similar to devices already cleared by the FDA. The submission effectively leverages the prior clearance of the predicate device (K183024) to support the safety and effectiveness of the new device, arguing that any differences (like the presence of chambers) do not raise new questions of safety or effectiveness.

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The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle:

post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for uncemented applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.

The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.

This document, K210308, is a 510(k) Premarket Notification for a medical device. It describes a new iteration of a total knee implant, the EMPOWR POROUS FEMUR with HAnano Surface™. The document focuses on demonstrating substantial equivalence to a predicate device, as clinical testing was not required for this submission. Therefore, the information provided primarily concerns non-clinical testing and comparisons, rather than a detailed study proving the device meets an extensive set of acceptance criteria through clinical trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through non-clinical testing, rather than explicit performance metrics derived from a clinical trial with pre-defined success/failure thresholds. The reported performance is framed in terms of meeting these comparison points.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The "test set" here refers to non-clinical laboratory tests on device components or full devices. The document does not specify the number of samples used for each non-clinical test (e.g., how many devices were subjected to abrasion testing).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, DJO Surgical (Legal Name: Encore Medical, L.P.). The document does not specify the country of origin for these lab tests, but it is implied to be internal testing or contracted testing performed under the manufacturer's oversight. The testing is not retrospective or prospective clinical data, but rather bench and material testing.

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

• This question is not applicable as there was no "ground truth" derived from human experts for a clinical test set. The ground truth in this context would be the results of the non-clinical tests (e.g., passing or failing a fatigue test, measured wear rates). These results are obtained through standardized testing protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. There was no human "test set" in need of adjudication. The non-clinical tests have objective outcomes based on established methods and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a medical implant (total knee prosthesis), not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described in the provided text.

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

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

7. The Type of Ground Truth Used

• As discussed, "ground truth" here refers to the outcomes of the non-clinical tests. The types of "ground truth" used are:
  • Engineering Test Results: Measurements from abrasion testing, pin-on-disk wear testing, fatigue testing, contact area testing.
  • Biocompatibility/Safety Testing: Bacterial endotoxin assessment results compared against pre-defined specifications (20 EU/device).
  • Material and Geometric Specifications: Confirmation that the new device's substrate material, geometry, and porous coating are identical to the predicate.
  • Predicate Device Performance: Reliance on the previously cleared predicate's mechanical testing results for identical geometries.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission as it does not involve machine learning or AI.

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

• Not applicable. See point 8.

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The Innovasis® TxTiHA™ IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis® AxTiHA™ Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.

AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.

The provided text is a 510(k) summary from the FDA for two intervertebral body fusion devices, the TxTiHA™ IBF System and the AxTiHA™ Stand-Alone ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than presenting a clinical study or acceptance criteria in the typical sense for a new AI/medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially those related to clinical trials, AI, ground truth, and human reader performance) is not present in this document.

However, I can extract the information that is available:

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

The document does not provide a table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing:

The core "acceptance" for this type of device (a 510(k) submission) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Sample Size: Not applicable. The document describes non-clinical performance testing of the devices themselves (e.g., mechanical strength), not a clinical test set involving patient data or imaging. Therefore, concepts like sample size of patients, data provenance, retrospective/prospective studies, or country of origin are not mentioned.
• Data Provenance: The non-clinical tests likely occurred in a lab setting. The company is Innovasis, Inc. in Salt Lake City, Utah, USA.

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 document does not describe a clinical study requiring human experts for ground truth establishment.

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

Not applicable. There is no test set in the clinical sense 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:

Not applicable. This is not an AI-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an AI device.

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

Not applicable. The "ground truth" for these physical devices is their compliance with specified ASTM standards and material properties, verified through non-clinical mechanical testing, rather than clinical outcomes or expert labels.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set described.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for singleunit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N. - validated milling center for manufacture.

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. The K170392 submission included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. Components cleared in K 170392 included the Unitite line of dental implants that have a threaded endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA""). All other dental implants cleared in K170392 had a threaded endosseous surface that was acid-etched only (no HA100).

This submission adds the following components to the S.I.N. Dental Implant System: the identical HA1000 coating to the Strong SW CM (Morse taper) implant line cleared in K170392; the identical HA™® coating to the Strong SW HE (external hexagon) implant line cleared in K170398; the identical HA-"00 coating to the Strong SW HI (internal hexagon) implant line cleared in K170398: a new implant line, Tryon Conic HE, with an external hexagon abutment interface; a series of conventional (not CAD-CAM) prosthetic components that are compatible with implants from the S.I.N. Dental Implant System; and a series of CAD-CAM prosthetic components for fabrication of patient-specific restorations that are compatible with implants from the S.I.N. Dental Implant System.

This document is a 510(k) Premarket Notification from the FDA regarding the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies is not available and cannot be extracted from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The document outlines design and material specifications for various components and compares them to predicate devices, but it does not list specific numerical acceptance criteria or performance metrics for the device itself. The "PERFORMANCE DATA" section states "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation... bacterial endotoxin testing and shelf life testing... biocompatibility data... and biocompatibility testing for the ISO 13356 zirconia material... No clinical data were included in this submission." This indicates that performance data generally refers to compliance with standards (e.g., ISO, ASTM) and physical/biological characteristics, not clinical performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical or performance study with a "test set" and corresponding sample size is described. The non-clinical data mentioned are related to validation and biocompatibility, not a clinical performance study.

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 is no mention of a test set requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

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 is for a dental implant system, not an AI software or system that involves human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a dental implant system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth is established for performance evaluations in this submission, as it relies on substantial equivalence to predicate devices based on design and material similarities, and compliance with recognized standards.

8. The sample size for the training set: Not applicable. This is not an AI/algorithm submission requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm submission requiring a training set.

In summary, the provided text describes a 510(k) submission for a dental implant system, which focuses on demonstrating substantial equivalence through comparisons of design, materials, and intended use with already cleared devices and adherence to relevant non-clinical standards (sterilization, biocompatibility, etc.). It explicitly states that "No clinical data were included in this submission." Therefore, the detailed information requested about acceptance criteria, study design, and performance metrics in the context of clinical or comparative effectiveness studies is not present.

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