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Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula.

Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is

The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

Here's an analysis based on the provided 510(k) summary for Norian Reinforced and Norian Reinforced Fast Set Putty:

Key Takeaway: This 510(k) summary is for a medical device (bone cement), not an AI/ML powered device. Therefore, many of the requested sections related to AI/ML specific evaluation criteria (e.g., sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The "study" here refers to a comparative non-clinical study against predicate devices, focusing on material properties and biocompatibility.

Acceptance Criteria and Study Details (Non-AI/ML Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a bone cement, the "acceptance criteria" are related to its physical properties, biocompatibility, and intended use as compared to predicate devices. The document doesn't provide specific quantitative tables for acceptance criteria and performance values in the way one would for an AI model. Instead, it states that the device meets the requirements through comparative testing.

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

• Sample Size: Not specified in the provided summary. This would refer to the number of material samples tested for mechanical, in-vitro, and biocompatibility assessments.
• Data Provenance: Not specified, but generally, such tests are conducted in laboratories following specific standards (e.g., ISO, ASTM). The data would be from controlled laboratory experiments, not patient data.

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

• Not Applicable. This is a medical device (bone cement) undergoing non-clinical testing for material properties and biocompatibility, not an AI/ML system requiring expert-based ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this doesn't involve subjective human interpretation or diagnostic agreement typical of AI/ML evaluation. Performance is based on objective measurements against established material standards and comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a bone cement, not an imaging AI diagnostic aid. MRMC studies are not relevant for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a physical medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Objective Material Science and Biocompatibility Standards: The "ground truth" for this device's performance is based on established scientific and engineering principles for material properties (e.g., strength, setting time), chemical composition, and biological response as defined by recognized standards (e.g., ISO 10993 for biocompatibility). The comparison point is often the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/ML model that requires a training set. The device formulation and manufacturing process are developed through R&D and engineering, not machine learning training.

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

• Not Applicable. As with point 8, there is no "training set" in the context of an AI/ML model for this type of device.

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