(186 days)
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:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use | Same as predicate devices (Paltop Dental Implant System, MIS UNO Narrow, Astra Tech OsseoSpeed Narrow). |
| Technological Characteristics | Similar to predicate devices (same operating principle, basic design, materials, packaging, sterilization procedures). Specific comparisons are detailed in the "Technological Characteristics – comparative table – Narrow Implants" for: |
- 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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.