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The Provide 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 cement retained to the abutment.

The Provide Temporary Cylinders will be made of the same material (PEEK) as the PreFormance Posts. The cylinder is cemented onto an abutment. An acrylic resin provisional restoration can be built onto the cylinder. The height of these cylinders will be 6.5mm and the platform diameters are 4.8 and 6.5mm. Furthermore, they will be used as single use to support a single-unit restoration and multi use where two or more cylinders are splinted together to support a provisional multi-unit restoration

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

Based on the provided K061177 document, the information available does not describe a study involving detailed acceptance criteria and performance metrics typically associated with AI/software devices or clinical effectiveness studies. This submission is for a physical dental implant component, a device modification, and relies on substantial equivalence to a predicate device.

Therefore, many of the requested categories for AI/software device evaluation (like sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's a breakdown of the available information in relation to your request:

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

Study Proving Acceptance Criteria:

The "study" proving the acceptance criteria here is a Substantial Equivalence determination based on comparison with a predicate device (PreFormance Posts, K053170). The submission does not contain explicit details of a clinical study or performance testing with quantitative acceptance criteria for this specific device modification. Instead, it leverages the established safety and effectiveness of the predicate device.

The lack of specific performance standards is explicitly stated: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act."

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

• Not Applicable. This submission does not describe a clinical or performance test set in the way an AI/software device would. The evidence is a comparative analysis to a predicate device based on material, function, and indication for use.

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)

• Not Applicable. There's no "ground truth" to be established by experts in the context of a dataset for this type of physical device's substantial equivalence pathway. The "ground truth" is effectively the regulatory approval and established performance of the predicate device.

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

• Not Applicable. No test set or adjudication method described for a clinical or performance study.

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 is a physical dental implant component, not an AI or imaging device. Therefore, no MRMC study would be performed.

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

• Not Applicable. This is a physical dental implant component, not an algorithm or software.

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

• For this type of 510(k) submission, the "ground truth" for demonstrating safety and effectiveness is the established safety and effectiveness of the legally marketed predicate device (PreFormance Posts, K053170), to which the new device is compared for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

• Not Applicable. No training set for an algorithm is involved.

In summary: K061177 describes a submission for a physical medical device modification (dental implant accessory). Its approval is based on demonstrating substantial equivalence to a previously cleared predicate device, rather than a new clinical study with specific acceptance criteria, test sets, or ground truth defined for an AI/software product. The listed "performance" in the document explicitly states that formal performance standards have not been established by the FDA for this class of device under the given section of the Act.

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