Search Results

Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.

Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for a medical device, Adin Short Implants. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device and its performance metrics.

The document details the substantial equivalence of the Adin Short Implants to predicate dental implants through a comparison of their technological characteristics and non-clinical performance data. This includes:

• Device Description: The physical characteristics of the Adin Short Implants (self-tapping, root-form, two-piece screw type, made of Titanium 6AL-4V-ELI Alloy, specific lengths and diameters, surface treatments).
• Intended Use: Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients to restore chewing function, with immediate loading possible under certain conditions.
• Substantial Equivalence: A detailed comparison table (pages 8-9) of the subject device with several predicate devices, highlighting similarities in classification, indications for use, patient population, sterility, body contact, prescription status, single use, operation principle, placement method, self-tapping, implant material, biocompatibility, shape, connection (with some variations), surface treatment, implanted length, outer diameter, abutment angulation, packaging, and shelf-life.
• Non-Clinical Performance Data (Page 6-7):
  • Pull-Out Testing: Measured axial pull-out strength compared to predicate devices, according to ASTM F543.
  • Comparative Bone to Implant Contact Surface Area Analysis: Compared to predicate devices.
  • Comparative Surface Analysis Before Surface Treatment: Compared to predicate devices.
  • Biocompatibility: Tests conducted according to FDA Guidance for ISO 10993-1, ISO 10993-5, ISO 10993-11, and ISO 10993-18.
  • Surface Analysis After Surface Treatment: Using SEM/EDS.
  • Gamma Sterilization Validation: According to ISO 11137-2 and ISO/TS 13004.
  • Shelf-life validation: According to ISO 11607-1.
  • MR Environment Condition: Non-clinical worst-case MRI review based on scientific rationale and published literature.

The document concludes that the Adin Short Implants are substantially equivalent to the predicate devices and do not introduce new risks.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets the acceptance criteria with respect to AI/ML device performance metrics because the provided text is for a mechanical dental implant and does not involve AI/ML.

If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

Ask a specific question about this device

TOUAREG CloseFit™ UNP 2.75mmD implants are indicated to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.

The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.

All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.

The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.

The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The provided document is a 510(k) premarket notification for a dental implant device, the TOUAREG CloseFit™ UNP 2.75mmD. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

Based on the information provided, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CADe device. Instead, it demonstrates equivalence to predicate devices through non-clinical performance data (fatigue testing). The "performance" here refers to the device's mechanical integrity under simulated conditions.

2. Sample Size for Test Set and Data Provenance

The document does not describe a "test set" in the context of evaluating an AI/CADe device. The performance evaluation is based on non-clinical fatigue testing of the physical dental implant device. The sample size for this physical testing is not specified.

Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as this is laboratory testing of a manufactured medical device, not analysis of patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation is not for an AI/CADe system requiring expert-established ground truth from medical images or clinical data. The judgment of "equivalence" is made by the FDA based on the submitted non-clinical test reports.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" requiring expert adjudication in the context of an AI/CADe device performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This section is not relevant as the device is a physical dental implant, not an AI/CADe system intended to assist human readers.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study was not done. This section is not relevant as the device is a physical dental implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by conformance to a recognized international standard (ISO 14801:2007 for fatigue testing) and comparison to predicate devices, demonstrating mechanical equivalence. There is no biological or pathological "ground truth" in the typical sense for an AI/CADe device.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant, not an AI algorithm that requires a training set.

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

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

Ask a specific question about this device

Intended use for Touareg NP CloseFit™ Dental Implant System:

• To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
• For single-stage or two-stage procedures.
• For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
• The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
• The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.

Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.

Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.

Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).

The provided text is a US FDA 510(k) premarket notification for a dental implant system. It describes the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. However, it does not contain a typical study report structure with specific acceptance criteria and detailed performance results that would be expected for a device proving its own acceptance criteria in the way a clinical trial or a performance study would.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary requirement for a 510(k) submission. This means the device is shown to be as safe and effective as a predicate device, rather than meeting novel acceptance criteria derived from a primary clinical study.

Therefore, many of the requested points (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set size, training set ground truth) are not directly applicable or available in this type of regulatory document. The "study" described here is a bench performance test (fatigue testing) used to compare the new device to its predicates.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

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

The document doesn't present a specific "acceptance criteria" table in the format typically seen for novel device performance claims. Instead, it states that the device was subjected to fatigue testing in accordance with FDA guidance and ISO 14801:2007. The acceptance criterion for this type of test is typically that the device must withstand a specified number of cycles at a certain load without failure, demonstrating performance equivalent to or better than the predicate.

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

• Sample Size: The document mentions "worst-case test samples" were identified and subjected to fatigue testing. It does not provide the specific number of samples (N) used for this testing.
• Data Provenance: The tests are non-clinical, bench-top tests conducted to ISO standards. The company is Adin Dental Implant Systems Ltd. from Israel. The testing itself would likely have been done in a laboratory, potentially in Israel or by a certified testing facility elsewhere. This is not
  retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the "test set" here refers to physical dental implant samples for bench testing, not a dataset requiring expert interpretation for ground truth.

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

This is not applicable for physical bench testing. The evaluation is based on objective measurements and observations of mechanical failure or integrity according to the ISO standard.

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. This submission is for a physical medical device (dental implant), not a diagnostic AI device requiring human reader interaction or multi-reader studies.

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

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

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

For the fatigue testing, the "ground truth" is the physical performance of the device samples against engineering and material science standards (e.g., ISO 14801:2007), where failure is an objective event. For sterilization, the "ground truth" is the demonstration of microbial lethality to achieve the specified Sterility Assurance Level.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable.

Ask a specific question about this device