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si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, pelvis). These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. si-Mochi resorbs and is replaced with bone during the healing process.

si-Mochi contains a multi porous bi-phase Calaium Phosphate ceramic granules, 12mm, suspended in an aqueous polymer carrier gel. The chemical composition of the multi-porous ceramic granules is trace silicate induced bi-phase calcium phosphate ceramic which has 80% hydroxylapatite Ca5(PO4)3(OH) and 20% beta -tricalcium phosphate Ca3(PO4)2 , similar levels to those identified in naturally-growing bone. Its porous structure comprising three types of porosities which are interconnected: macropores (100µm1mm), midipores (10100 µm) and microspaces (110 µm). Calcium phosphate bone graft substitutes have been the topic of extensive clinical studies for several decades. Biocompatibility is addressed in the non-clinical testing section below. The interconnected macro-, midi- and micro- porous structure encourages the rapid formation of host bone and the growth of capillary blood vessels throughout the network of interconnecting pores. After implantation, si-Mochi undergoes physiologically- mediated resorption and is replaced by natural bone. The resorption of the Ca/P porous ceramic granules were controlled by the host nature bone remodelling process due to the proliferated osteocytes formation within the microporous structure of the ceramic granules. The resorption is not controlled by its chemical composition. si-Mochi is supplied in three different types of sterile applicator. si-Mochi does not set in-situ following implantation. si-Mochi does not contain antibiotics.

The provided text is a 510(k) Premarket Notification from Biostone Limited for their device si-Mochi. This document details the device's description, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the content of the provided document, the device in question, si-Mochi, is a resorbable calcium salt bone void filler, not an AI-powered image analysis device. Therefore, the information required to answer the questions about acceptance criteria for an AI/ML device, such as performance metrics (accuracy, sensitivity, specificity, AUC), sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, are not present in this document.

The document focuses on non-clinical and animal studies to demonstrate substantial equivalence to legally marketed predicate devices (TriPore® K070132, Actifuse ABX™ K082575).

Here's an analysis based on the information available in the document, highlighting what is missing in relation to the prompt:

Missing Information (as per the prompt's requirements for AI/ML device study):

• Acceptance Criteria for an AI device's performance: Not applicable; this is a medical implant, not an AI device.
• Reported Device Performance against AI acceptance criteria: Not applicable.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for AI test sets. The document mentions an animal study (rabbit critical size defect in the distal femora model), but details on sample size within that study are not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI. For the animal study, the "ground truth" would be the observed new bone formation in the animal model.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information Available (related to the device's clearance):

The only "study" mentioned in the document is an "animal study, rabbit critical size defect in the distal femora model, making direct comparison against the predicate device, Actifuse ABX."

• Acceptance Criteria (for demonstrating substantial equivalence in this context): The implicit acceptance criterion for this type of device is "substantial equivalence" to predicate devices, meaning it performs as well as the predicate device regarding safety and effectiveness.

  • The document states: "Biostone has determined that si-Mochi is substantially equivalent to the predicate devices on the basis of chemical composition tests on all three devices as prescribed in the 'Class II Special Controls Guidance Document' referenced above."
  • And: "Secondly, si-Mochi itself complies with the requirements of the Special Controls Document referred to above."
  • And: "Animal study, rabbit critical size defect in the distal femora model, making direct comparison against the predicate device, Actifuse ABX. However, the percentage of new bone formations were not statistically significant difference in animal model at all time points post-implantation between si-Mochi and the predicate device."
  • Therefore, the "acceptance criteria" here are demonstrated comparability of chemical composition, compliance with special controls, and non-inferiority/statistical non-significance in new bone formation compared to the predicate in an animal model.

• Reported Device Performance (against the above criteria):

  • Chemical Composition: Stated to be comparable and comply with guidance.
  • Animal Study: "the percentage of new bone formations were not statistically significant difference in animal model at all time points post-implantation between si-Mochi and the predicate device." This indicates the device performed comparably to the predicate.

• Sample Size (for the animal study): Not explicitly stated in the provided text.

• Data Provenance (Animal Study): Rabbit model. Country of origin not specified, but the submitter is in the UK.

• Ground Truth (for Animal Study): The direct measurement of "percentage of new bone formations" in the animal model.

In summary, this document is for a medical implant, not an AI/ML diagnostic tool, and as such, the specific metrics and study designs outlined in your prompt for AI applications are not relevant or present.

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