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The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.

Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.

The document discusses:

• Device Name: Surcam Dental Implant System
• Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
• Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
• Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
• MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
• Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.

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Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Surgikor Abutment Blanks and Abutments are intended to be used in conjunction with Surgikor endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed abutments for use with Surgikor Abutment Blanks are intended to be sent to a Surgikor validated milling center for manufacture.

The Surgikor Fixation One implant is an alternative version of the 4.3 and 5.0 mm diameter Fixation implants that uses the regular platform used by the 3.5mm Fixation implants. The Surgikor abutment blanks and abutments consist of hexagonal and conical abutments made from abutment blanks, an additional hexagonal healing cap, and multi-unit abutments for conical RP and WP. Surgikor implants and abutments are made from Ti6AL4V ELI.

Fixation One is a root form implant that is appropriate for both immediate load applications and insertion into fresh extraction sockets. Fixation One is offered with a conical connection in regular platform. The Fixation One regular platform implant is available in 4.3, and 5.0 mm diameter and has available lengths of 8.5, 10, 11.5, 13, 15, and 18 mm.

Healing cap for internal hex in 3.75mm x 7mm in standard emergence.

Multi-Unit Abutment in conical RP and WP are available in heights of 1.5, 2.5, and 3.5 mm. An angled multi-unit of either 17° (2.5 or 3.5 mm) or 30° (3.5 or 4.5 mm) is available for conical connections of regular and wide platform. Multi-unit abutments are intended for multiple unit restorations only. Angled multi-units use RP and WP conical multi-unit screws.

Surgikor Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Surgikor Blank Abutments have an engaging implant connection. Abutments made from Surgikor Blank Abutments use internal hex abutment screws and RP & WP conical abutment screws from K182615.

The design parameters for customized abutments fabricated from Titanium Blank Abutments are: Minimum wall thickness – 0.4 mm Minimum post height for single-unit restorations (length above the abutment collar / gingival height)— 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.7 mm Maximum angulation - 25° (in relation to the long axis of the implant)

All abutment blanks are made of titanium alloy conforming to ASTM F136. Abutments made from the blanks are only for use with Surgikor dental implants of the implant/abutment interface on the package label and are not to be used with other dental implant designs. This includes Versatile Hex 3.5mm and larger, Immediate Hex 3.75mm and larger, and Solution Fixation & Fixation One conical 3.5mm and larger.

There are 3 models of abutment blank: internal hex, conical RP and conical WP.

Minimum diameter at abutment/implant interface: Versatile Hex 3.5mm Immediate Hex 3.75mm Solution 3.5mm Fixation 3.5mm Fixation One 4.3mm

Maximum length of abutment from abutment/implant interface: Versatile and Immediate Hex 13.00mm Solution 9.5mm Fixation and Fixation One 9mm

The provided text is a 510(k) Premarket Notification from the FDA regarding the Surgikor Fixation One, Abutment Blanks, and Abutments. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that a device meets specific acceptance criteria through a clinical or performance study involving an AI algorithm or human readers.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system because:

• The document is for a dental implant system (physical medical devices), not an AI algorithm or software. The "device" in question (Surgikor Fixation One, Abutment Blanks, and Abutments) is a set of physical components used in dental implant procedures, made from Ti6AL4V ELI material.
• The "study" discussed is a demonstration of substantial equivalence. This involves comparing the new device's indications for use, materials, design, principles of operation, and sterilization to legally marketed predicate devices. It does not involve performance metrics like sensitivity, specificity, or human improvement with AI assistance.
• There is no mention of algorithms, AI, human readers, or image analysis. The testing summary mentions cytotoxicity, steam sterilization, gamma irradiation validation, LAL testing, shelf-life, surface assessment, bench testing, and an MRI environment review, all related to the physical properties and safety of the dental implants.

The document does not contain any of the information required to populate the fields related to acceptance criteria for an AI-powered diagnostic device.

Summary of why the requested information cannot be extracted from the provided text:

The document describes a 510(k) submission for mechanical dental implants and abutments. It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than presenting a performance study of an AI-driven system or a system involving human interpretation of data. Therefore, details such as algorithm performance, sample sizes for AI training/testing sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI models are not present.

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IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.

ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.

PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.

Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.

Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).

Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.

This document is a 510(k) Premarket Notification summary for the IDCAM Dental Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/device performance study are not applicable to this type of regulatory submission for a dental implant.

Here's an analysis of the provided text in relation to your request:

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 in the way you'd expect for an AI or diagnostic device assessing clinical outcomes (e.g., sensitivity, specificity).
Instead, it demonstrates substantial equivalence to predicate devices for a physical implant. The "acceptance criteria" here are more about meeting recognized standards and being comparable to legally marketed devices.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical images. For mechanical testing (like ISO 14801), the sample sizes would be a small number of physical implant components tested in a lab, not patient data. These details are typically in a separate test report, not summarized in the 510(k) summary itself.
• Data Provenance: The data comes from in-vitro (lab-based) physical and chemical testing of the device components, not from clinical studies on patients. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable here.

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

Not applicable. "Ground truth" in this context refers to the defined properties of the materials and the performance under standardized mechanical tests, not clinical diagnoses made by experts.

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

Not applicable, as this relates to expert review of clinical data, which was not the basis of 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

Not applicable. This is a medical device (dental implant), not an AI diagnostic software. No human reader studies were conducted or required for this type of submission.

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

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

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

The "ground truth" for the device's performance is established by:

• Adherence to recognized international standards (e.g., ISO 14801 for fatigue testing, ISO 10993-5 for cytotoxicity, ISO 11137 for sterilization).
• Material specifications (ASTM F136).
• Comparison to the established, legally marketed predicate device's characteristics and performance under these same standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

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

Not applicable.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" in this context is a series of engineering and biocompatibility tests designed to demonstrate that the IDCAM Dental Implants are substantially equivalent to a legally marketed predicate device (SpiralTech Dental Implant System Ultimate Conical K170372, and reference predicates Cortex K090709 and K163385).

• Objective: To show that the new device is as safe and effective as the predicate device, and does not raise new questions of safety or effectiveness.
• Methodology:
  • Indications for Use Comparison: The Indications for Use statement for IDCAM Dental Implants was compared directly to that of the predicate device and found to be "same."
  • Material Comparison: The device material (ASTM F136 Ti 6Al 4V ELI) was confirmed to be identical to the predicate device. Biocompatibility testing per ISO 10993-5 was performed.
  • Design Comparison: Detailed design specifications (diameters, lengths, connections, screw types, abutments, etc.) were compared. Minor differences in specific sizes were acknowledged but deemed not to change substantial equivalence given similar use, materials, and technology.
  • Performance Testing (In-Vitro):
    • Dynamic fatigue testing according to ISO 14801: This standard evaluates the endurance limit of endosseous dental implants under cyclic loading. The reported performance was that IDCAM implants "exhibited a run out limit equivalent to other implant systems," specifically comparable to the predicate.
    • Surface Modification Information: Provided per FDA Guidance Document for Endosseous Dental Implants and Abutments.
    • Sterilization Validation: Conducted per ISO 11137-1,-2,and -3 for implants and ISO 17665-2 and ANSI/AAMI ST79 for abutments.
    • Package Integrity Testing and Accelerated Aging: Per ISO 11607-1 and -2.
    • Endotoxin Testing: Per USP 161.
• Conclusion: Based on these comparisons and performance tests demonstrating equivalence in indications for use, materials, design, and fatigue performance, the FDA determined that the IDCAM Dental Implants are substantially equivalent to the predicate device.

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DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm. All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm. Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient. The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.

The provided text describes a 510(k) premarket notification for the DSI Dental Implant System, asserting its substantial equivalence to legally marketed predicate devices. The document details the device, its indications for use, and a summary of testing conducted to support this claim.

It does not describe an AI/ML powered medical device, nor does it present acceptance criteria and a study proving the device meets those criteria in the way typically expected for such products (e.g., performance metrics like sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this dental implant system are framed in terms of demonstrating substantial equivalence to a predicate device, primarily through materials, design, and fatigue performance.

Therefore, many of the requested points regarding AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device (dental implants).

However, I can still extract information related to the device's performance testing and comparison to predicates, interpreting "acceptance criteria" in the context of demonstrating substantial equivalence for a non-AI device.

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

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test (e.g., how many implants were fatigue tested) or the provenance (country of origin, retrospective/prospective) of any clinical data, as this is primarily a non-clinical, performance-based submission. The testing appears to be lab-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML evaluation by experts is not relevant here. The evaluation is against engineering standards and comparison to predicate devices, which is typically conducted by engineers and regulatory experts.

4. Adjudication method for the test set
Not applicable for this type of device and 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/ML 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 device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference for evaluating this device's performance is based on recognized international standards (ISO, ASTM, USP) for medical devices, specifically dental implants, and comparison to legally marketed predicate devices. For example, mechanical strength is compared against the run-out limits established by ISO 14801.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established
Not applicable.

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Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.

The Surgikor Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems including multi-unit abutments. Implants are made from Ti6ALAV ELI.

The Surgikor Dental Implant System includes:

Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with a Morse tapered hex connection. The regular hex platform comes in diameters of 3.5, 3.75, 4.2, 4.5, 5.0 and 6.0mm. Lengths of 8, 10, 11.5, 13 and 16 are available with 18 and 20 mm lengths available in the 4.2 diameter only.

Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with a Morse tapered hex connection in regular platform. It is available in 3.75, 4.2, 4.5, 5.0, 6.0, and 7.0 mm diameter. The hex is regular platform and comes in lengths of 7 (4.5, 5, 6.and 7mm only), 8, 10, 11.5, 13, 16 (7.0mm diameter not in 11.5,13 or 16 mm length).

Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a conical connection in narrow, regular and wide platforms. The 3.0 diameter implant is available in narrow platform and lengths of 10, 11.5, 13 and 15mm. The Fixation regular platform implant is available in 3.5 and 3.9 mm diameter and has available lengths of 8.5, 10, 11.5, 15, and 18 mm. Wide platform is available in 4.3 and 5.0 mm diameter with lengths of 8.5, 10, 11.5, 13, 15 and 18mm.

Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in narrow platform with a diameter of 3.25mm and lengths of 10, 11.5, 13, 15 mm. The regular platform is available in 3.5, and 4.0 diameter in lengths of 7.0 (4.0 diameter only), 8.5, 10. 11.5, 13, 15mm. The wide platform is available in diameters of 4.5. 5.0. 5.5 and 6.0mm. These diameters come in lengths of 7.0. 8.5. 10. 11.5. 13. and 15mm. The Solution2 is available with lengths of 10. 11.5. 13. and 16 mm in a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Versatile model, while the Solution2 have an outer thread like the Immediate model.

Healing caps are available in 3 platform sizes: normal, narrow and wide. The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. There is also a wide platform conical connection healing cap for both narrow emergence and wide emergence. These are 4.3 mm diameter in lengths of 2, 3, 4, 5, 6 and 7 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2. 3. 4. 5. 6. 7 mm and a diameter of 3.75 mm and standard & wide emergence regular platform with lengths of 2,3, 4, 5, and 6 mm and a diameter of 3.75 mm. There is also a healing cap for the multiunit abutment which comes in one size. Healing caps with marks for scanning are available in 2mm length for regular hex, narrow conical, regular conical and wide conical platforms.

Temporary abutment is for immediate loading if appropriate. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5, 6 and 7 mm and diameters of 3.0, 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.

Non-shouldered abutments are straight titanium abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 (not in narrow conical) mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width, a wide conical platform of 4.3mm and with a regular hex platform of 3.75 mm width. Also available is a wide emergence non-shouldered straight abutment with lengths of 5, 7, 9, 12 and 15 mm with a wide conical platform of 4.3 mm. The 5mm height nonshouldered abutments are intended for multiple unit restorations only.

15° and 25° angular non-shouldered abutments: 15° abutments are supplied in lengths of 9, 11 and 13 mm with either a hex connection (3.75mm) or a conical connection in narrow (3.0mm), regular (3.5mm) or wide (4.3mm) platform. 25° abutments are supplied in lengths of 9, 11 and 13 mm with a hex connection, a conical connection regular platform or a conical connection wide platform. 15° and 25° narrow emergence abutments are supplied as a hex connection regular platform with a width of 3.75 mm. 15° and 25° wide emergence abutments are supplied as a wide platform conical connection with a width of 4.3 mm and lengths of 9, 11, and 13mm.

Anatomic Straight Shouldered Abutments All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: conical connection, narrow, regular or wide platform or hex connection regular platform. Wide emergence versions are available in wide conical connection and regular hex connection.

15°, and 25° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and shoulder heights of 1, 2 and 3 mm. They are available in conical connection, narrow (available in 15° only), regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical.

Ball Attachment Abutments are provided with lengths of 1, 2, 3, 4, 5, and 6 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter. Ball attachment abutments are intended for multiple unit restorations only.

Multi-Unit Abutment are supplied with lengths of 1, 2, 3 and 4 mm. They are available in narrow regular and wide conical platforms and in hex regular platform. An angled multi-unit of either 18° or 30° is available for conical connections of narrow, regular and wide platform. A plastic sleeve for casting an extension for using multi-units in single units is included in the 510k. Multi-unit abutments are intended for multiple unit restorations only.

Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only.

Castable abutments are available in hexed and non-hexed in hex or conical connection (all three platforms). They are available in Ti alloy and gold. A plastic sleeve is available for use with the castable abutments. They are intended for casting straight abutments taller than 4mm.

Abutment Screws are available for hex connection and for all three platforms of conical connection.

Cover Screw are supplied with a conical connection as narrow, regular and wide and with a hex connection.

The provided text is a 510(k) summary for the Surgikor Dental Implant System, detailing its substantial equivalence to predicate devices. However, it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of an AI/ML system.

The document focuses on the physical characteristics, materials, and mechanical testing of dental implants and their associated components (abutments, healing caps, etc.). The "Testing Summary" refers to:

• Dynamic fatigue testing according to ISO 14801: This is a standard for evaluating the fatigue strength of dental implants. The acceptance criterion is "Sufficient run out load for their intended use."
• Surface cleanliness analysis: "all tests were passed."
• Biocompatibility of materials (gold for UCLA abutments, CoCr for castable abutments): "was shown to be biocompatible."
• Sterilization according to ISO 11137-1 and 11137-2: "was conducted on the implants."
• Abutment steam sterilization according to ISO 17665-1 and -2: "was done."
• Material conformity to ASTM F136.
• Endotoxin testing according to USP 161: "was conducted."

These are standard regulatory requirements for medical devices and do not relate to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device, as the document does not discuss such a device or its associated studies.

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OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. Osse one implants are intended for single or multiple unit restorations on splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

OsseOne Dental Implant System is an internal hex implant system with two models of implant, OsseoLock which is a cylindrical implant and OsseoPlus which is a spiral implant. OsseoLock comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. OsseoPlus comes in diameters of 3.5, 3.75, 4.2, 5.0 and 6.0. The implants come in lengths of 8, 10, 11.5, 13 and 16. OsseoLock 5.0 and 6.0 diameter implants do not come in 16mm length. Both straight and angled abutments are available. The implants have a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi-unit abutments, denture lock abutments, overdenture abutments, angled overdenture abutments, ball attachments, healing caps (3.8, 4.6, 5.5, and 6.3 mm diameter), UCLA in 4.5mm diameter and standard 15° and 25° abutments are included in the system.

The provided text describes the OsseOne Dental Implant System and its equivalence to a predicate device, the SpiralTech Dental Implant System. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML device performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device.

The document discusses the following types of testing for the OsseOne Dental Implant System:

• Dynamic fatigue testing (ISO 14801): To determine abutment strength.
• Surface analysis: According to FDA guidance.
• Sterilization validation: For implants (ISO 11137-1 and ISO 11137-2) and abutments (ISO 17665-1 and ISO 17665-2).
• Package integrity testing and accelerated aging: According to ASTM F1929-12, ASTM F 1980-07(2011), ASTM D 4332-13, ASTM D 999-08, ASTM D4169-09, ASTM D5276-98(2009), and ASTM F 3039-13.
• Materials testing: ASTM F136.
• Endotoxin testing: USP 161.
• Cytotoxicity testing: ISO 10993-5.

The study presented is a substantial equivalence comparison study where the OsseOne Dental Implant System is compared to the SpiralTech Dental Implant System.

Acceptance Criteria and Reported Device Performance (Table):

Missing Information (as per your request for AI/ML devices):

The provided text does not contain any of the following details, as the device is not an AI/ML device:

• Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method (e.g. 2+1, 3+1, none) for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

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