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The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

The PreFormance Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The temporary cylinders have a material retention feature located on the cylinder body area, whereas the posts do not have this feature on the post body.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the "PreFormance™ Temporary Cylinders" device:

This document is a 510(k) Premarket Notification for a device modification, specifically for "PreFormance Temporary Cylinders." The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a PMA (Pre-Market Approval) or some de novo classifications might require.

Therefore, the information for many of your requested points will be "Not Applicable" or "Not Provided" because the nature of a 510(k) submission for a device modification typically focuses on showing that the modified device is as safe and effective as its predicate without the need for extensive new clinical performance studies. The "study" here refers to the comparison against the predicate device rather than a de novo clinical trial with specific performance metrics.

Acceptance Criteria and Device Performance for PreFormance™ Temporary Cylinders

Given that this is a 510(k) submission demonstrating substantial equivalence based on a modification of an existing device, the "acceptance criteria" are primarily related to material, design, and functional similarity to the predicate device, thereby inferring similar performance. Performance standards have not been established by the FDA for this type of device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable / Not provided. This 510(k) does not describe a clinical "test set" in the context of a performance study with human subjects. The evaluation is based on a comparison to the predicate device and potentially engineering analysis or bench testing (which is not detailed in this summary).
• Data Provenance: Not applicable / Not provided for a clinical test set. The submission is a comparison to the company's own predicate device (PreFormance Posts).

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

• Number of Experts: Not applicable / Not provided. Ground truth in the context of a clinical performance study with expert adjudication is not part of this 510(k) submission.
• Qualifications of Experts: Not applicable / Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable / Not provided. No human subject test set or adjudication process is described.

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

• MRMC Study Done?: No. This type of study is not relevant to a device modification 510(k) submission that demonstrates substantial equivalence primarily through material and functional similarity to a predicate.
• Effect Size of AI Improvement: Not applicable. AI is not mentioned or implied in this device or its evaluation.

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

• Standalone Performance Done?: No. This device is a physical dental accessory, not an algorithm or software. Its performance is inherent in its physical properties and interaction with dental implants and prosthetics.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (PreFormance Posts, K053170). The current device is compared against this known performance and characteristics.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/ML device or a device requiring a clinical trial with a training phase.

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

• How Ground Truth Was Established: Not applicable / Not provided. As there's no training set, this is not relevant. The "ground truth" for the substantial equivalence claim relies on the FDA's prior clearance of the predicate device.

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