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The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days.

The Temporary Snap Abutments are premanufactured dental implant abutments directly connected to endosseous dental implants and are intended for use as a temporary aid in prosthetic rehabilitation. The Temporary Snap Abutments are available in engaging and non-engaging connection designs and with collar heights of 1.5 and 3.0 mm. The Temporary Snap Abutments are compatible with the Nobel Biocare dental implants that have the Narrow Platform (NP), Regular Platform (RP) or Wide Platforms (WP) internal conical connection.

While the provided document is a 510(k) premarket notification for a medical device (Temporary Snap Abutment), it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what the document does provide:

• Type of Document: This is a submission to the FDA seeking a determination of "substantial equivalence" to a predicate device. This process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, often by showing it has the same technological characteristics or that any differences do not raise new questions of safety or effectiveness. It typically relies on comparison to existing devices and performance data from those predicates, rather than extensive de novo clinical trials or detailed performance metrics for the new device itself.

• Missing Information:

  1. Acceptance Criteria Table: There is no table of acceptance criteria for the Temporary Snap Abutment's performance. The document focuses on comparing its technological characteristics and intended use to predicate devices.
  2. Reported Device Performance: While "Summary of Non-Clinical Testing" is mentioned, it only discusses biocompatibility and sterilization validations, leveraging data from the predicate. It does not provide specific performance metrics for the Temporary Snap Abutment itself (e.g., strength, durability, fit, etc.) Nor does it describe a study that directly tests these performance aspects of the subject device against specific acceptance criteria.
  3. Sample Sizes and Data Provenance for Test Set: Not applicable, as there's no described performance study for the subject device. The biocompatibility and sterilization "testing" mentioned doesn't involve a test set in the way a clinical or performance study would.
  4. Number of Experts/Qualifications for Ground Truth: Not applicable, as there's no ground truth establishment for a performance study of the subject device.
  5. Adjudication Method: Not applicable.
  6. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study.
  7. Standalone Performance: While non-clinical testing for biocompatibility and sterilization is mentioned, it's not a "standalone performance" study in the sense of demonstrating the device's functional efficacy or safety attributes as a new device against specific criteria. Instead, it leverages predicate data.
  8. Type of Ground Truth: Not applicable.
  9. Training Set Sample Size/Ground Truth for Training: Not applicable, as this document is not describing a machine learning or AI device that would have a training set.

What the document does state regarding performance/testing:

The document states that the subject device does not represent a new worst case compared to the predicate (K133731). Therefore, data from the predicate was leveraged for:

• Device Packaging: Same as predicate, no additional testing required.
• Biocompatibility: Subject device is made from the same material (titanium vanadium alloy ASTM F136 and ASTM F1472) using the same manufacturing method, has the same intended use and patient contact type/duration as the predicate. Cytotoxicity and GC-MS analysis were performed in accordance with EN ISO 10993-1 (a standard), confirming no leachables or cytotoxic effect. No additional testing was required for the subject device itself beyond this.
• Sterilization: Validations were performed to ensure sterility of the subject devices when processed by the end user. These were done using autoclaves with fractionated prevacuum and gravity specific air displacement, with worst-case dental devices as described in AAMI TIR12: 2010.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of design features, materials, and intended use to legally marketed predicate devices, along with leveraging existing biocompatibility and sterilization data from analogous devices or standard testing protocols, rather than presenting a detailed study of the subject device's performance against specific, quantifiable acceptance criteria.

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