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ORTHOSS® is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). ORTHOSS® can be used with autograft as a bone graft extender in a posterolateral spine fusion. These osseous defects may be surgically created or be the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with bone during the healing process.

Orthoss® is an inorganic bone matrix, manufactured from bovine bone, with an interconnected macro- and microporous structure that supports the formation and ingrowth of new bone. Over time, Orthoss® is partially remodeled by osteoclasts (physiological remodeling). The single-use product is provided sterile (via gamma irradiation) in block (1 x 1 x 2 cm and 2 x 2 x 1.3 cm) or granular (1 - 2 mm and 2 - 4 mm) form in double-blister packs or glass vials in a blister pack, respectively.

This document discusses the 510(k) premarket notification for Orthoss®, a resorbable calcium salt bone void filler. It describes the device, its indications for use, comparison to a predicate device, and performance data provided to support its substantial equivalence.

Here's an analysis to extract the requested information:

Analysis of the document for Acceptance Criteria and Study Details:

The document describes a medical device (Orthoss®), not an AI/software device. Therefore, the questions related to AI performance metrics (e.g., human reader improvement with AI, standalone AI performance, training set details, expert ground truth establishment for AI) are not applicable to this submission.

The "acceptance criteria" for this device are primarily demonstrated through substantially equivalent (SE) determination to a predicate device, supported by performance data demonstrating safety and effectiveness. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance studies, particularly an animal study for an extended indication.

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI device, there isn't a table of statistical performance metrics like sensitivity/specificity for disease detection. Instead, "acceptance criteria" are implied by the demonstration of substantial equivalence across various aspects.

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

• Test Set Description: The "test set" here refers to the animal study conducted to support the extended indication.
• Sample Size: The document states "Rabbits were randomized to receive Orthoss®, MASTERGRAFT® Resorbable Ceramic Granules, or autograft control." (Page 5). It does not specify the exact number of rabbits in each group or overall.
• Data Provenance: The study used a "validated Boden rabbit spinal fusion model." (Page 5). This is a prospective animal study. The country of origin of the data is not explicitly stated but implies a controlled laboratory setting.

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

• This question is Not Applicable in the context of this device. The ground truth for the animal study (bone healing, fusion, etc.) was established through direct observation, radiographic analysis, micro-computed tomography, and histological analysis of the animal tissue, not by human expert readers interpreting images for disease diagnosis. The evaluation was primarily objective measurements and pathological assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As this is an animal study involving direct biological and imaging measurements (radiographs, micro-CT, histology, manual palpation), there is no mention of "adjudication" in the sense of multiple human readers resolving disagreements on interpretations. The results were based on direct observation and analysis by the researchers and pathologists involved in the study.

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 is a medical device (bone void filler), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• For the animal study: The ground truth was established through a combination of:
  • Radiographic appearance (direct imaging evidence)
  • Micro-computed tomography (detailed 3D imaging of bone structure)
  • Histology (microscopic examination of tissue, considered the gold standard for bone formation and remodeling)
  • Manual palpation (a physical assessment of fusion rigor)
  • Multidirectional flexibility measurements of the spine.

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. No training set was involved.

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