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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.

This submission expands the Predicate Narrow Implant device to include 3.0 mm diameter implants, additional implant thread configurations and additional prosthetic components to the previously cleared Paltop Narrow Implant (K130462).

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Paltop Narrow Implant are one- and two-stage endosseous screw type dental implants with associated abutments. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy which conforms to ASTM F136. The Paltop Narrow Implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched).

The implants are available in three thread/body configurations: Advanced, Advanced+, and Dynamic. The Advanced, Advanced+ and Dynamic implants have micro threads at the neck. All implants have a parallel coronal and mid-section area with an apical taper. The families have slight differences in thread profile and either a passive or active apex. The 3.0 mm diameter implants are prosthetically compatible with the previously cleared Paltop Narrow Implant (K130462) prosthetic devices.

This submission introduces Single-Unit Abutments for the Paltop Narrow Implant device. The submission replaces the original straight Multi-Unit Abutments from the K130462 submission and includes additional gingival heights. The submission also introduces an angulated Multi-Unit titanium abutment, all compatible with the Paltop Narrow Implant device. The submission expands the compatible prosthetic components to include new temporary titanium abutments and healing caps compatible with Single-Unit and Multi-Unit titanium implant abutments.

The Subject device implants may be used with the Predicate device abutments previously cleared under K130462, based on non-clinical performance bench testing provided in this submission.

The Subject device abutments may be used with the Predicate device implants previously cleared under K130462, based on non-clinical performance bench testing provided in this submission. The only exception is the implant cover screw (P/N 80-70100) which is specific to the 3.0 mm diameter implants in this submission.

The Subject device Multi-Unit Abutment components such as copings/interfaces, temporary abutments, cylinders, and screws may be used with the Predicate device Multi-Unit Abutments previously cleared under K130462 based on non-clinical performance bench testing provided in this submission.

All implants and prosthetic components are one-time use devices. All Subject devices in this submission are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings and all replacement screws which are provided non-sterile. Devices provided as non-sterilized by steam.

Here's a breakdown of the acceptance criteria and the study information for the Paltop Narrow Implant, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics like fatigue life or bone-to-implant contact percentages. Instead, it refers to industry standards and general outcomes. The reported device performance is presented narratively.

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

The document does not explicitly state a test set sample size for each specific non-clinical test in terms of a number of devices. It refers to general testing.

• For the bone changes evaluation (part of biocompatibility/osseointegration): "A total of 174 surfaces were graded (87 implants)."
• Data provenance: The bone changes evaluation references "published literature" on patients, suggesting retrospective (or possibly prospective clinical studies mentioned in the literature). "Internal routine monitoring data" and "post-market surveillance data" are mentioned, indicating real-world data collection, likely retrospective for surveillance and ongoing for monitoring. The manufacturer is Paltop Advanced Dental Solutions, Ltd, Hashita 5, Industrial Park, Caesarea 3088900, Israel.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document doesn't specify the number or qualifications of experts used to establish "ground truth" for the test set. For the bone level evaluation, it states "Mesial and distal surfaces were examined and graded." It is implied that these evaluations were done by qualified clinical professionals as part of the published literature or internal monitoring, but no specific details are provided.

4. Adjudication Method

No adjudication method is mentioned for any of the evaluations (e.g., bone level grading, or evaluation of non-clinical tests). The document implies acceptance based on test results meeting standards or being comparable to predicate devices.

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

No MRMC comparative effectiveness study is mentioned. This device is an endosseous dental implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study

The primary studies detailed are "non-clinical bench performance testing." This refers to laboratory testing of the device itself (fatigue, pull-out, etc.) and biological evaluations based on literature review and historical data, which are "standalone" in the sense that they assess the device's physical and biological properties. There is no human element being assessed.

7. Type of Ground Truth Used

The ground truth used several types:

• Industry Standards: For fatigue testing (ISO 14801:2016), endotoxin testing (USP ), and sterilization (ISO 17665-1).
• Clinical Outcomes Data: For osseointegration and implant survival (from published literature and post-market surveillance). This includes "bone level improvement or maintenance" and "failure rates below industry levels."
• Analytical Data: SEM/EDS data for residual particles.
• Comparison to Predicate/Reference Devices: Demonstrating similarity in design and performance to already cleared devices.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of an algorithm or AI. This is a medical device (dental implant) that undergoes physical and biological performance testing, not a machine learning model.

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

Not applicable, as there is no training set for an algorithm described in this document.

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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:

• Product Code
• Manufacturer
• Intended Use/Indications for Use
• Components
• Supplied Sterile
• Re-Use
• Material Composition
• Surface Treatment
• Shape
• Length
• Diameters
• Abutments
• Material Composition of Abutments
• Surface Treatment of Abutments |
  | Safety and Effectiveness | "Fatigue testing of the modified device showed that implants are safe and effective and meets existing acceptance criteria."
  "Other performance testing and validations (corrosion resistance, surface analysis, biocompatibility evaluation, sterilization and shelf life validation) previously conducted to the standard device were shown to be applicable to the modified design, as their results may not be affected by the dimensional changes."
  "Bench testing and validations demonstrates that the narrow implants are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness." |

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.

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