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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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TAV Medical 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 and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."

Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
• Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).

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

Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance

Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the TAV Medical Dental Implant System is based on:

• Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
• Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
• Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
• Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
• Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.

8. The Sample Size for the Training Set

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

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

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

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