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Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH. The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°. The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.

I am sorry, but the document you provided does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental device (Multi-Unit Abutments) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's what the document does include:

• Device Identification: Multi-Unit Abutments with Angulations 17° and 30° for Inclusive Tapered Implant System.
• Predicate Device: Zimmer Dental Angled Tapered Abutment (K111853).
• Device Description: Details on abutment sizes, materials (titanium alloy), and intended use.
• Indications for Use: What the device is intended for (support and retention for multi-unit screw-retained restorations, with specific parallelism requirements for 30-degree and 17-degree abutments).
• Substantial Equivalence Claim: The device is substantially equivalent to the predicate in intended use, indications for use, material, design, and performance.
• Non-Clinical Testing:
  • It states that non-clinical test data was used to support safety and effectiveness.
  • Testing involved "analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
  • The conclusion of this testing was that "the device is safe and effective for its intended use and performed as well or better than the predicate device."

However, the document does NOT contain the specific details you requested, such as:

1. A table of acceptance criteria and reported device performance: While it mentions testing, it doesn't quantify "acceptance criteria" or provide specific performance metrics in a table format. It only states the device "performed as well or better than the predicate device."
2. Sample size used for the test set and data provenance: No information on how many abutments were tested or where the test data came from.
3. Number of experts used to establish ground truth and their qualifications: No mention of experts or ground truth establishment.
4. Adjudication method: Not applicable as no expert review process is described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical device, not an AI or imaging system.
6. Standalone performance study: The non-clinical testing implicitly serves as a standalone performance evaluation against a standard and the predicate, but it's not detailed.
7. Type of ground truth used: Not applicable in the context of this device's testing.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The non-clinical testing mentioned appears to be mechanical and material testing, common for implantable medical devices, rather than a clinical study or an AI algorithm validation study. The standard referenced, "FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," would outline the specific tests (e.g., fatigue strength, torque retention, biocompatibility) required for these types of devices, and presumably, the acceptance criteria would be defined within those standards. However, the summary provided here does not detail those specifics.

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