Search Results

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching. The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided. The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

Below is an analysis of the provided text regarding the Paltop Narrow Implant's acceptance criteria and studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria. Therefore, explicit numerical acceptance criteria and corresponding device performance values are not directly stated in the document.

Instead, the acceptance for this device is based on demonstrating comparability with predicate devices in terms of:

2. Sample Size for the Test Set and Data Provenance

The document explicitly states "Clinical Tests: Not applicable." This indicates that no human test set was used for this 510(k) submission. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices. The data provenance is therefore from bench testing conducted by Paltop Advanced Dental Solutions Ltd. specific to the modified device design and existing data for the standard device. The country of origin of the device manufacturer is Israel.

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

Since no clinical test set was used, there was no ground truth established by experts for a clinical study. The "ground truth" for demonstrating substantial equivalence was established through analytical and bench testing data compared against the characteristics of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

Not applicable. The document explicitly states "Clinical Tests: Not applicable," and therefore no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical dental implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" was established through:

• Bench Test Results: Demonstrating material properties, mechanical strength (fatigue), corrosion resistance, surface analysis, biocompatibility, sterilization, and shelf-life meet acceptable standards and are comparable to predicate devices.
• Comparison to Predicate Device Specifications: The detailed comparative table and narrative establish equivalence based on the known and accepted characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm, therefore there is no concept of a "training set" in the context of this submission. The "training" for the device's design and manufacturing would involve engineering principles and design verification and validation, not data-driven algorithm training.

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

Not applicable, as there is no "training set" for a physical dental implant. The development and validation process would involve design inputs, design verification, and design validation activities, often referencing international standards and established scientific principles for medical device safety and performance.

Ask a specific question about this device

The Paltop 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 Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Paltop Dental Sterile Accessories are packaged is a standard, commonly used in the dental market, blister packaging made out of radiation resistant transparent polyethylene (PET) sealed with medical grade tyvek sheet. The accessories will be sterilized using gamma irradiation.

Paltop Prosthetic Components include a variety of abutments, healing cups and impression coping components having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. The Paltop prosthetic components, as other available in the market dental prosthetics are dental components composed either of titanium (Ti6AL4V ELI) or peek.

Paltop surgical instruments consist of a variety of instruments required for dentalsurgical and reconstructive procedures including primary and final drills, Key set and adapters. The Paltop surgical instruments, as other available in the market surgical instruments, are composed of stainless still or TI6AL4V ELI.

The provided text is a 510(k) Summary for a medical device (Paltop Dental Sterile Accessories). It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The submission is a Special 510(k), which indicates a modification to an existing cleared device (Paltop Dental Implant System cleared under K112795). The modification described is a change in packaging only: "Paltop modified devices will be provided in a sterile blister package."

Since the modification is solely a packaging change and does not alter the intended use, technological characteristics, or mode of operation, the submission focuses on validating the new sterile blister package and its sterilization method.

Here's an analysis based on the information provided, specifically addressing why certain requested information is not present:

Missing Information and Why (Based on the Document):

The request asks for information typically found in clinical performance studies or detailed engineering/software validation reports for novel devices or significant modifications that impact performance. This document is for a packaging change and sterilization validation for previously cleared devices.

Therefore, the following information is not available in the provided text:

• 1. A table of acceptance criteria and the reported device performance: This document validates a packaging change and gamma sterilization. Performance criteria would typically relate to the implant's clinical performance, which was established in the predicate device's clearance (K112795). For this submission, validation focused on sterility and packaging integrity.
• 2. Sample size used for the test set and the data provenance: Not detailed for device performance as it relates to clinical outcomes. For sterilization validation, there would be sample sizes, but these are not provided in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a packaging and sterilization validation. Ground truth for clinical performance was established for the predicate device.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is not an AI/imaging device with human-in-the-loop.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific 510(k) submission, as it concerns packaging. For the predicate device, clinical outcomes would be the ground truth for implant performance.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

Information Provided (Relevant to the Packaging Change Validation):

The document mentions:

• Non-Clinical Tests: "Risk analysis process was conducted to assess the impact of the modification of the device. Gamma radiation sterilization and shelf life validation were performed. Other performance testing and validations conducted for Paltop's original components (Fatigue, steam sterilization) were shown to be applicable to the modified device. Bench testing and validations demonstrates that Paltop dental sterile accessories are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness."

This indicates that the key validations for this submission were:
* Risk analysis of the packaging change.
* Validation of gamma radiation sterilization.
* Shelf-life validation for the new packaging.
* Confirmation that previous performance tests (Fatigue, steam sterilization) on the components themselves are still valid.

• Clinical Tests: "N/A" - No clinical tests were performed for this specific modification, as it was deemed unnecessary due to the nature of the change (packaging only).

In summary, this 510(k) submission is for a minor modification (packaging change) to an already cleared device. Therefore, it does not involve the extensive performance studies and acceptance criteria typically associated with novel devices, AI/ML devices, or devices undergoing significant functional changes. The "study" mentioned is the non-clinical testing for sterilization and shelf-life related to the new packaging.

Ask a specific question about this device

The Paltop 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 Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments. The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136. "Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. "Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.

The provided document is a 510(k) summary for the Paltop Advanced Dental Solutions Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for acceptance criteria.

Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested by the user for an AI/ML device.

Here's a breakdown of the available information in relation to the requested points:

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

This information is not explicitly provided in the document in the context of acceptance criteria and performance metrics typically expected for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate dental implants through technological characteristics and compliance with established standards for dental implants.

The "performance" described is in the context of mechanical, material, and biological properties, not a predictive or diagnostic AI/ML performance.

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

This information is not provided. The non-clinical tests mentioned are fatigue, corrosion resistance, surface analysis, and biocompatibility, which are standard tests for physical medical devices, not AI/ML systems.

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 information is not applicable and therefore not provided. The device described is a dental implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from images or other data.

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

This information is not applicable and therefore not provided. As the device is a physical dental implant, there is no "test set" in the context of AI/ML performance evaluation 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

This information is not applicable and therefore not provided. The device is a dental implant and does not involve AI assistance for human readers/clinicians, nor does it present "cases" for interpretation.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve an algorithm.

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

This information is not applicable in the context of AI/ML ground truth. For the physical dental implant, ground truth is implicitly established by compliance with international standards for material properties, mechanical performance (e.g., fatigue), and biocompatibility. Clinical effectiveness is generally inferred from the substantial equivalence to existing devices with a long history of safe and effective use.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

Summary regarding the provided document:

The 510(k) submission for the Paltop Advanced Dental Solutions Implant System focuses on demonstrating substantial equivalence to predicate dental implant devices, as opposed to providing detailed acceptance criteria and a study for an AI/ML device. The "study" referenced in the document for clinical aspects is a literature review, which concludes that titanium-based dental implants are safe and effective. The "acceptance criteria" are implied by compliance with various international standards for biocompatibility, material properties, and mechanical performance relevant to dental implants (e.g., ISO, ASTM standards listed on pages 4, 6, and 7). There are no AI/ML specific details in this document.

Ask a specific question about this device