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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.

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