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GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.

GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 4555). GlassBone Granules is composed by weight of 4555 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O). It is sterilized with gamma irradiation and is single use and is available in different unit sizes.

The provided text describes the 510(k) premarket notification for "GlassBone Granules," a resorbable calcium salt bone void filler device. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with the detailed elements requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies (MRMC) as these are not present in the provided document.

The document states:

• "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

This means that the FDA's clearance for GlassBone Granules was based on its substantial equivalence to an already legally marketed predicate device (BonAlive Granules - K231528) and a reference device (NovaBone Resorbable Bone Graft Substitute - K052494), rather than a clinical study with new performance data.

Instead of a clinical study proving performance against acceptance criteria, the submission relied on non-clinical performance data (bench testing, animal testing, biocompatibility, sterility, and shelf life) to demonstrate that the device is as safe and effective as the predicate.

Here's a breakdown of what is in the document regarding the "study" that proves the device meets requirements, interpreted in the context of a 510(k) submission focused on substantial equivalence:

1. Table of "Acceptance Criteria" and "Reported Device Performance":
Not applicable in the traditional sense of a clinical trial for a standalone AI/software product, or a device requiring specific performance metrics against a disease state. The "acceptance criteria" here are implied by the standards and guidance documents followed to demonstrate equivalence.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable as no clinical test set was used for a performance study. Non-clinical bench and animal testing typically use specific quantities of samples as per ASTM and ISO standards, but these details are not provided here.
• Data provenance: Not applicable for a clinical test set. The non-clinical data would have been generated in labs as part of the device development and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical test set with human ground truth (e.g., image annotation) was established. The ground truth for non-clinical tests is based on objective measurements and established scientific methods (e.g., chemical analysis, microbiological assays).

4. Adjudication method for the test set:

• Not applicable as no clinical test set requiring human adjudication was used.

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 device is a physical bone void filler, not an AI software. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm/software device.

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

• For the non-clinical tests, the "ground truth" is based on the objective measurements and scientific standards applied in the bench (e.g., chemical composition analysis, particle size distribution) and animal (e.g., histological analysis of tissue response, biocompatibility markers) studies. There is no "ground truth" in the sense of clinical annotations or outcomes data from a patient cohort.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

In summary, the FDA document indicates that the "GlassBone Granules" device's safety and effectiveness were demonstrated through a comparison to a legally marketed predicate device and through robust non-clinical (bench and animal) testing that confirmed its material properties, biocompatibility, sterility, and shelf life, showing it performs comparably to established devices. No clinical studies or AI-specific performance evaluations were deemed necessary or conducted for this 510(k) submission.

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