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The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair The Donesourgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface or nourcement but notes) e defect. BoneSource is also indicated for augmentation or arestoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.

The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previouslycleared BoneSource hydroxyapatite cement powder along with a new prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are being provided in sizes ranging from 5 g to 50 g.

The provided text is related to the 510(k) submission for BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• Proprietary Name: BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit
• Common Name: Hydroxyapatite Cement (HAC)
• Intended Use: Repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects, and augmentation/restoration of bony contour in the craniofacial skeleton (fronto-orbital, malar, mental areas).
• Predicate Device: BoneSource Hydroxyapatite Cement (K953339, K864537 and K970400) and Norian® CRS™ Craniofacial Repair System (K973789).
• Device Description: It's an expanded kit containing previously cleared BoneSource hydroxyapatite cement powder, a new prefilled syringe with sodium phosphate solution, and a mixing spatula.

The 510(k) summary only describes the device and its intended uses, and asserts substantial equivalence to predicate devices. It does not include details on performance testing, acceptance criteria, or specific studies that demonstrate the device meets any performance criteria. Therefore, I cannot generate the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement.

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The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm per defect.

The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement that hardens in an aqueous environment at body temperature and consists solely of calcium phosphate compounds. The cement is mixed freshly at the time of implantation and can be applied directly into the defect to fill the void. BoneSource® remains malleable for approximately 20 minutes during which time it can be contoured to custom-fit the defect. The setting reaction is complete after four hours. BoneSource® is fabricated by combining two phosphates of calcium (i.e., dicalcium phosphate and tetracalcium phosphate). At the time of use, BoneSource® is combined with sterile water which results in an isothermic setting reaction yielding pure HAC after four hours. Under in-vitro conditions (37°C), the product hardens in approximately 20 minutes. After four hours, the reaction is complete, yielding pure hydroxyapatite with no significant dimensional changes and no by-products. The compressive strength of BoneSource® is ≥ 50 MPa. The BoneSource® paste during the setting reaction has been determined to be in the range of 6.5 to 8.5. As a consequence of its apatitic nature, the product is highly compatible with both soft and hard tissue. Approximately 45% of the implant volume consists of micropores (the remainder is solid) with an average pore size of

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the BoneSource® Hydroxyapatite Cement:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a bulleted or numbered list with corresponding "reported performance." Instead, it describes various tests and their outcomes, implying that successful outcomes from these tests constituted the basis for acceptance. I have inferred the acceptance criteria based on the described testing and conclusions.

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

• Clinical Test Set:

  • Sample Size: 103 patients presenting 175 cranial defects.
  • Data Provenance: Prospective, non-randomized clinical investigational study conducted under an approved Investigational Device Exemption. Country of origin is not explicitly stated but implied to be the US, given the FDA 510(k) submission.

• Animal Studies Test Set:

  • Hydroxyapatite Cement: Basic Chemistry and Histologic Properties: 9 cats.
  • Hydroxyapatite Cement: Obliteration and Reconstruction of the Cat Frontal Sinus: 9 cats.
  • Experimental Hydroxyapatite Cement Cranioplasty: 6 cats for primary study, plus 3 additional cats for controls.
  • 30-Day HAC Cranial Implant Test (Biocompatibility): 2 dogs (10 defects total, 8 with BoneSource®, 2 controls).
  • Data Provenance: Prospective animal studies. No country of origin specified.

• In-Vitro Testing: Sample sizes for specific in-vitro tests (e.g., number of specimens for dimensional verification, compressive strength) are not explicitly detailed, but implied to be sufficient for scientific assessment.

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

• Clinical Study:

  • Effectiveness (Radiographic Evaluation): The assessment was done by "radiographic evaluation (x-ray or CAT Scan)." The number and qualifications of the readers or experts who performed these evaluations are not specified within this summary.
  • Safety (Complications/Adverse Events): "Considered by the Investigator and Medical Monitor." This implies at least two experts (Investigator, Medical Monitor). Their specific qualifications (e.g., number of years experience) are not provided, but they would be medical professionals overseeing the clinical trial.
  • Histopathology (30-Day HAC Crania Implant Test in dogs): A "blinded histopathological evaluation" was performed. The number and qualifications of the histopathologist(s) are not specified.

• Animal Studies: The histological and radiographic evaluations in the cat studies were conducted, but the specific number and qualifications of the experts (e.g., veterinary pathologists, radiologists) who established the ground truth are not mentioned.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. For "Effectiveness" evaluation (volume loss), the method for combining or adjudicating multiple radiographic interpretations (if more than one reader was used) is not described. For "Safety" related to device-relatedness of outcomes, it states "considered by the Investigator and Medical Monitor," implying a consensus or adjudicated decision between at least these two individuals.
• 30-Day HAC Cranial Implant Test (dogs): A "blinded histopathological evaluation" was performed, but the adjudication method (e.g., if multiple pathologists disagreed) is not detailed.

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?

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This document describes the safety and effectiveness of a medical device (a bone cement), not an AI diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• Not Applicable. This document describes a physical medical device (bone cement), not a diagnostic algorithm.

7. The Type of Ground Truth Used

• Clinical Study:
  • Effectiveness: Based on radiographic evaluation (x-ray or CAT Scan) for implant stability (volume loss) and evaluation of explants (physical assessment).
  • Safety: Based on laboratory data (blood chemistry) and direct clinical observations and records of postoperative complications and adverse events, interpreted by medical professionals.
• Animal Studies:
  • Histology: Direct examination of tissue samples for bone growth, resorption, tissue reactions, etc. (e.g., "Examination of decalcified and undecalcified sections," "blinded histopathological evaluation").
  • Imaging: Computed tomography and radiographs.
  • Gross observation: Direct visual assessment of implant site, wound, etc.
• In-Vitro Tests: Based on laboratory measurements and analytical techniques (e.g., X-ray Diffraction, pH meter, micrometers for dimensional changes, mechanical testing for compressive strength).

8. The Sample Size for the Training Set

• Not Applicable. This document describes the testing of a physical medical device, not a machine learning model. There is no concept of a "training set" in this context. The animal and in-vitro studies could be analogized to preclinical foundational research, but not a dataset for training an algorithm.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant to the provided text.

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The Osteogenics BoneSource™ Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2 per defect.

The Osteogenics BoneSource™ Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement that hardens in an aqueous environment at body temperature and consists solely of calcium phosphate compounds. The cement is mixed freshly at the time of implantation and can be applied directly into the defect to fill the void. BoneSource™ remains malleable for approximately 20 minutes during which time it can be contoured to custom-fit the defect. The setting reaction is complete after four hours. BoneSource™ is fabricated by combining two phosphates of calcium (i.e., dicalcium phosphate and tetracalcium phosphate). At the time of use, BoneSource™ is combined with sterile water which results in an isothermic setting reaction yielding pure HAC after four hours. Under in-vitro conditions (37℃), the product hardens in approximately 20 minutes. After four hours, the reaction is complete, yielding pure hydroxyapatite with no significant dimensional changes and no by-products. The compressive strength of BoneSource™ is ≥ 50 MPa. The pH of the BoneSource™ paste during the setting reaction has been determined to be in the range of 6.5 to 8.5. As a consequence of its apatitic nature, the product is highly compatible with both soft and hard tissue. Approximately 45% of the implant volume consists of micropores (the remainder is solid) with an average pore size of

Here's a breakdown of the acceptance criteria and the studies performed for the BoneSource™ Hydroxyapatite Cement (HAC), based on the provided document:

Acceptance Criteria and Reported Device Performance

Detailed Study Information:

2. Sample Size for Test Set and Data Provenance:

• In-vitro Testing: Not specified, but laboratory-based testing.
• Animal Testing:
  • "Basic Chemistry and Histologic Properties": 9 cats.
  • "Obliteration and Reconstruction of the Cat Frontal Sinus": 9 cats.
  • "Experimental Hydroxyapatite Cement Cranioplasty": 6 cats for main study, 3 additional cats for controls.
• Biocompatibility Testing:
  • Guinea Pig Delayed Contact Sensitization Test: Not specified.
  • USP Intramuscular Implant Test: Not specified.
  • 30-Day HAC Cranial Implant Test: 2 dogs (10 defects).
• Clinical Testing:
  • Patients: 103 patients.
  • Cranial Defects: 175 cranial defects.
  • Data Provenance: Prospective, multi-site clinical investigation conducted under an approved Investigational Device Exemption (IDE). Countries of origin are not explicitly stated, but it's a US FDA submission, implying US-based studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Clinical Testing (Effectiveness - Radiographic Evaluation): The effectiveness was determined by "volume loss at each postoperative interval." While radiographic evaluation (x-ray or CAT Scan) was used, the number and qualifications of experts performing these evaluations are not specified.
• Clinical Testing (Safety - Explantation Review): "Medical Monitor" and "Investigator" reviewed explantations and their relation to the device. Specific numbers and qualifications are not provided.
• 30-Day HAC Cranial Implant Test (Animal Study): "A blinded histopathological evaluation of the defects was performed." The number and qualifications of the histopathologists are not specified.

4. Adjudication Method (Test Set):

• The document does not explicitly describe an adjudication method for reconciling differing opinions (e.g., 2+1, 3+1). For clinical evaluations and histopathology, it primarily mentions evaluations being performed or reviewed by individuals/roles (Medical Monitor, Investigator, histopathologist).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was explicitly performed comparing human readers with and without AI assistance, as this device does not involve AI. The comparison is between BoneSource™ (HAC) and a predicate device (CranioPlastic™ / PMMA).

6. Standalone Performance Study (Algorithm only without human-in-the-loop):

• This question is not applicable as the device is a medical implant (cement), not an AI algorithm.

7. Type of Ground Truth Used (Test Set):

• In-vitro Testing: Scientific measurements (e.g., X-ray diffraction patterns, pH measurements, dimensional measurements, compressive strength tests).
• Animal Testing:
  • Healing/Integration: Histological examination, Computed Tomography, Radiographs, gross observation at sacrifice.
  • Complications: Gross observation at sacrifice, histological examination.
• Biocompatibility Testing: Standardized assays (e.g., cytotoxicity, sensitization, mutagenicity, endotoxin tests), histological evaluation.
• Clinical Testing:
  • Effectiveness: Radiographic assessment of volume loss (x-ray/CAT scan), evaluation of explanted devices.
  • Safety: Laboratory blood chemistry values, observation and reporting of postoperative complications and adverse events by clinical staff and investigators.

8. Sample Size for Training Set:

• This question is not applicable as the device is a physical implant, not an AI algorithm that requires a training set. The term "training set" is not relevant in this context.

9. How Ground Truth for Training Set was Established:

• This question is not applicable for the same reason as point 8.

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