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Orthocon MONTAGE Settable, Resorbable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use.

The provided document does not describe the acceptance criteria and a study proving a digital health device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device called "MONTAGE Settable, Resorbable Bone Putty."

Therefore, I cannot provide the information requested in points 1-9 as they pertain to the evaluation of a digital health device, specifically looking for metrics like human reader improvement with AI assistance, standalone algorithm performance, and details about training/test sets for AI models.

Instead, the document details the substantial equivalence of the MONTAGE Settable, Resorbable Bone Putty to a predicate device (Stryker Injectable Cement) based on technological characteristics and performance data.

Here's a summary of what the document does provide regarding the MONTAGE device's performance evaluation:

1. Acceptance Criteria and Reported Device Performance (Bench Testing):
   The document lists several bench tests with their conclusions, implying that the "met specification" or "acceptable" status indicates the device met its acceptance criteria for these specific properties.

   Test	Acceptance Criteria (implied by "met specification" or "acceptable")	Reported Device Performance
   Visual Inspection	Putty color and handling met specification	Putty color and handling met specification
   Putty Handling	Putty stickiness met specification	Putty stickiness met specification
   Putty Stiffness	Putty stiffness met specification	Putty stiffness met specification
   Putty Vitamin E Acetate Concentration	Putty vitamin E acetate concentration met specification	Putty vitamin E acetate concentration met specification
   Hand Mixing Time	Mixing time met specification	Mixing time met specification
   Hand Mixing Stickiness	Stickiness met specification	Stickiness met specification
   Mixability	Mixability met specification	Mixability met specification
   Device Stiffness	Device stiffness met specification	Device stiffness met specification
   Package Gross Leak	All test articles passed leak test	All test articles passed
   Temperature Sensitivity	Acceptable maximum temperature increase following hand-mixing	Acceptable maximum temperature increase following hand-mixing
   Water Uptake, Swelling, and Dissolution	Acceptable water uptake, swelling and dissolution	Acceptable water uptake, swelling and dissolution

2. Sample size used for the test set and the data provenance: Not applicable for a medical device without AI components. However, biocompatibility testing was conducted on the "final, finished, gamma-irradiation sterilized device," and in-vivo animal testing was performed using "New Zealand White rabbits."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.

7. The type of ground truth used:

   • Biocompatibility: In accordance with ISO 10993 recommendations and GLP requirements.
   • Bench Testing: Internal specifications derived from engineering and material science principles.
   • In-Vivo Testing: Histopathologic evaluation and histomorphometric measurements of implant absorption over time from animal study, compared to the predicate device.

8. The sample size for the training set: Not applicable for this type of medical device.

9. How the ground truth for the training set was established: Not applicable.

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