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Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.

Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

The provided text is a 510(k) summary for the Orthocon Permatage Settable Bone Putty, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment for an AI/algorithm-based device is not applicable to this document. The document describes a traditional medical device (bone putty) and its regulatory clearance process, which relies on biocompatibility testing, bench testing, and in-vivo animal testing to demonstrate substantial equivalence to an existing device, not an AI or software algorithm.

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

1. Table of acceptance criteria and reported device performance: Not present. The "Performance Data" section lists various tests (e.g., Visual Inspection, Paste Stiffness, Package Leak Test) and states that they "met specification" or "passed," but it does not provide specific numerical acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not present for a "test set" in the context of an algorithm. The in-vivo animal testing mentions demonstrating substantial equivalence in "an animal model," but does not specify the sample size of animals or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The in-vivo animal testing involved "histopathologic evaluation," which would have been performed by experts, but their number and qualifications are not specified.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted device.
6. Standalone performance (algorithm only without human-in-the-loop): Not applicable, as this is not an AI/algorithm device.
7. Type of ground truth used: For the in-vivo animal testing, "histopathologic evaluation" served as a form of ground truth for assessing the bone defect repair.
8. Sample size for the training set: Not applicable, as there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The document describes the regulatory clearance of a bone putty device (Permatage Settable Bone Putty) based on its substantial equivalence to another marketed device (Stryker HydroSet Injectable Cement). The evaluation involved:

• Biocompatibility Testing: Conducted in accordance with ISO 10993, including tests for cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity. All tests were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with GLP requirements.
• Bench Testing:
  • Visual Inspection: Evaluated paste color using a reference scale. Conclusion: Paste color met specification.
  • Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusion: Paste stiffness met specification.
  • Package Leak Test: Bubble emission leak test. Conclusion: All test articles passed.
  • Temperature Sensitivity: Acceptable maximum temperature increase observed. Conclusion: Acceptable maximum temperature increase observed.
  • Water Uptake, Swelling, and Dissolution: Measured volume and mass changes over time. Conclusion: Acceptable water uptake, swelling, and dissolution.
• In-Vivo Testing:
  • Study Design: Used to demonstrate substantial equivalence in the repair of a critical-sized cranial bone defect in an animal model compared to the comparator device.
  • Ground Truth: Substantial equivalence was assessed based on histopathologic evaluation.
  • Sample Size/Provenance: Not specified beyond "an animal model."
• Clinical Testing: No clinical studies were conducted in support of this 510(k).

The document concludes that the device is substantially equivalent to the predicate device, and the conducted tests passed stated requirements and recognized standards.

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Orthocon Montage Flowable Settable Bone Paste 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 Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The Montage Flowable device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage Flowable device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.

The provided document is a 510(k) summary for the Orthocon Montage Flowable Settable, Resorbable Bone Paste. This document is a premarket notification for a medical device and is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

• The device's name, regulation, and product code.
• Its intended use (repair of neurosurgical burr holes, cranial defects).
• Comparisons of technological characteristics with a predicate device (Stryker HydroSet Injectable Cement).
• Biocompatibility and performance testing (bench testing and in-vivo animal testing).
• A clear statement that no clinical studies have been conducted in support of this 510(k).

Therefore, the requested information about acceptance criteria and a study proving device performance for an AI/ML-based medical device cannot be extracted from this document, as it pertains to a different type of medical device (a bone paste) and the regulatory submission is not based on AI/ML performance.

To answer your prompt, I would need a document describing the regulatory submission for an AI/ML-based medical device, which would typically include detailed information on clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training and test sets.

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Orthocon MONTAGE-OS Settable 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-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

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

The provided text describes a medical device, MONTAGE-QS Settable, Resorbable Bone Putty, and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria and a study proving the device meets those criteria in the context of typical AI/software device evaluation.

Based on the provided information, here's an attempt to answer your request, focusing on the information that is present and noting where information is absent for an AI device.

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the performance evaluation is based on demonstrating equivalence to a predicate device through various tests. The "performance" for MONTAGE-QS is a qualitative assessment of its material properties and biological response compared to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Efficacy Evaluation (Cranioplasty): The study was conducted in a "rabbit cranial critical-sized defect model." The specific number of rabbits or defects studied is not provided.
  • Bench Testing: The sample sizes for each bench test are not specified.
  • In-Vivo Testing: Similar to the efficacy evaluation, it refers to an "animal model" without giving specific numbers.
• Data Provenance: The document states "rabbit cranial critical-sized defect model" and "in-vivo animal testing," indicating the data is from preclinical animal studies. The country of origin and whether it was retrospective or prospective data are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The "ground truth" for this device's evaluation (e.g., whether bone defects were filled, or histopathological assessments) would have been established by experts in veterinary pathology or relevant scientific fields. However, the document does not state the number of experts or their qualifications. The assessments are described as "histology-based assessments" and "histopathologic evaluation."

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

• The document does not describe any adjudication method for establishing ground truth or evaluating the test results.

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

• This is a submission for a bone putty, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• This is a submission for a bone putty, not an AI or software device. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

• For the efficacy and in-vivo testing, the ground truth was based on histopathologic evaluation in an animal model. For bench testing, it was based on measurable physical and chemical properties against predetermined specifications.

8. The sample size for the training set

• This is a submission for a physical medical device (bone putty), not an AI or software device. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is demonstrated through testing against specifications and comparison to a predicate, not by training an algorithm.

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

• As a training set is not applicable for this type of device, the method for establishing its "ground truth" is not applicable.

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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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DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.

DB-Cranial Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. DB-Cranial kit is comprised of two components: a calcium-phosphate powder and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3 cc, 5 cc, and 10 cc DB-Cranial Bone Void Filler kits are provided sterile to SAL of 10-6 and are for single use only. The sterilization method is gamma radiation. Sterilization validation is based on ISO 11137-2:2013 (VDMax25). DB-Cranial Bone Void Filler will be labeled with a shelf life of 30 months.

The document provided is a 510(k) summary for the DB-Cranial device. It describes various performance tests conducted to demonstrate substantial equivalence to a predicate device, OsteoVation® Impact (K162864).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Important Note: This document does not describe a study that uses AI or machine learning. It is a submission for a medical device (a calcium phosphate bone void filler) that undergoes physical and chemical performance testing to demonstrate substantial equivalence. Therefore, many of the requested bullet points regarding AI/ML studies (e.g., sample size for test set, data provenance, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for DB-Cranial were established by comparing its performance to that of the predicate device, OsteoVation® Impact (K162864). The "Results" column essentially serves as the reported device performance and also confirms that the device meets the implied acceptance criteria of being substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify the exact number of samples used for each test (e.g., number of specimens for tensile testing, number of batches for chemical analysis). The tests are typically conducted on a sufficient number of samples to ensure statistically sound results for material characterization.
• Data Provenance: The data provenance is generally from laboratory bench testing (in vitro simulations). The country of origin of the data is not explicitly stated, but it would typically be where the manufacturer (Dimensional Bioceramics, LLC, Santa Cruz, CA) or their contracted laboratories are located. The testing is prospective for the device being submitted, although it involves comparison to an already marketed predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involves physical and chemical property testing of a biomaterial, not subjective interpretation by medical experts. The "ground truth" for these tests comes from established scientific and engineering principles (e.g., ASTM/ISO standards for material testing, analytical chemistry techniques).

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

Not applicable, as there is no subjective adjudication required for quantitative and qualitative material property tests.

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 not an AI/ML-driven diagnostic or assistive device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for the performance tests is derived from:

• Established material science and engineering principles.
• Quantitative measurements made by validated analytical equipment (e.g., ICP-MS, XRD, mechanical testers).
• Qualitative observations based on scientific methodologies (e.g., FTIR, SEM).
• The performance of the legally marketed predicate device, used as a benchmark for "substantial equivalence."

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Osteo Vation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.

OsteoVation Impact is a self-setting, calcium phosphate bone void filler designed for single use and biocompatible. Osteo Vation Impact is an impactable (moldable) calcium phosphate.

OsteoVation Impact is comprised of two working components: a calcium phosphate, a sodium phosphate (SPMA), carboxymethylcellulose powder, a sodium silicate, sodium phosphate (SPMA) solution, and a mixing system (mixing bowl, pestle and spatula). The two working components are packaged separately and are to be mixed together by the end user prior to implantation.

OsteoVation Impact is offered in 3cc, 5cc, and 10cc sterile convenience kits. Each kit includes the two working components in combination with a mixing bowl, pestle, and spatula. It is sterilized using gamma radiation with a minimum dose of 25 kGy and a maximum dose of 50 kGy with a Sterility Assurance Level of 10-9.

The provided text describes the OsteoVation Impact, a calcium phosphate bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device (OsteoVation® CMF Bone Void Filler, K051784) rather than establishing novel acceptance criteria for a new type of device. Therefore, the "acceptance criteria" discussed here relate to ensuring the modified device maintains performance comparable to the predicate.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format with specific numerical targets for each test, but it describes how results were evaluated against the predicate device. The performance is consistently stated as "comparable to the predicate device" or "PASS," implying that the results fell within acceptable ranges established by the predicate's performance.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes (number of devices, batches, or specimens) used for each bench test. It mentions "All samples" passed for working and setting time but doesn't quantify "all."

The data provenance is bench testing conducted by Skeletal Kinetics, LLC. There's no mention of country of origin for data as it's mechanical/chemical testing. The tests are prospective for the modified device to demonstrate its performance.

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

N/A. This being a bench test study for a material, there isn't a "ground truth" established by experts in the typical sense (e.g., radiologist consensus for image analysis). The "ground truth" is derived from the objective physical and chemical properties and performance of the device and its comparison to a well-characterized predicate.

4. Adjudication Method for the Test Set:

N/A. This is not applicable to bench testing of material properties. The results are physical measurements and chemical analyses, not subjective assessments requiring adjudication.

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:

N/A. This study is for a medical device (bone void filler material), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

N/A. As above, this is about a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this submission is the established performance characteristics and material composition of the predicate device (OsteoVation® CMF Bone Void Filler, K051784). The goal of the study was to demonstrate that the modified OsteoVation Impact has comparable physical, chemical, and performance characteristics to this predicate, ensuring that the formulation change did not adversely affect its safety and efficacy.

8. The sample size for the training set:

N/A. This is not a machine learning or AI study, so there is no concept of a "training set."

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

N/A. There is no training set in this context.

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DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm2 or less.

DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.

Stryker DirectInject consists of a sterile dual paste system, provided pre-filled in a double barrel delivery syringe system, which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is injectable, moldable and biocompatible. The injected cement paste will harden under normal body conditions to form hydroxyapatite, which is the principle mineral constituent of bone. The contents are supplied sterile for single patient use in sizes of 3 cc, 5 cc, and 10 cc.

The provided text is a 510(k) summary for the Stryker DirectInject device, which is a calcium phosphate cement for cranioplasty. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with acceptance criteria in the typical sense of a clinical trial for diagnostic devices. Therefore, much of the requested information regarding diagnostic performance, ground truth, experts, and sample sizes for training/test sets is not applicable to this type of submission.

However, I can extract information related to the performance data provided to support the safety and effectiveness of the device, primarily through biocompatibility and bench testing.

Here's a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in a table format with corresponding numerical performance metrics for a diagnostic device. Instead, it describes performance testing conducted to demonstrate safety and effectiveness for a medical device (cranioplasty cement).

The acceptance criteria are implied by the standards the device was tested against. The "reported device performance" is generally stated as the device having passed these tests and performing as intended.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: For the in-vivo animal studies, the document mentions "a sheep and rabbit model." It does not specify the exact number of animals used in these models.
• Data Provenance: The biocompatibility and bench testing are laboratory-based. The in-vivo animal studies are conducted in animal models, likely in a research facility accredited with animal welfare standards. Country of origin for the data is not specified, but the submitter is Stryker Leibinger GmbH & Co. KG (Germany) with regulatory contact in Michigan (USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable. The device is a bone cement, not a diagnostic AI device requiring expert consensus for ground truth. The "ground truth" for biocompatibility and material properties is established by adherence to recognized international standards and scientific testing methodologies. For the animal study, macroscopic and histological evaluations would typically be performed by trained veterinary pathologists, but the number and qualifications are not specified.

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

• This is not applicable as it relates to expert review for diagnostic ground truth, which is not part of this submission type.

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

• This is not applicable. This is a medical device (bone cement), not a diagnostic AI system.

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

• This is not applicable. This is a medical device (bone cement), not a diagnostic algorithm.

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

• For biocompatibility: Ground truth is defined by the passing criteria of the specified ISO and ASTM standards.
• For physical properties: Ground truth is defined by the expected material characteristics (e.g., hydroxyapatite composition, mechanical strength, setting time) as measured against the respective standards and internal specifications.
• For in-vivo testing: Ground truth is established by macroscopic and histological evaluation demonstrating stability, osteoconductivity, and integration with bone tissue, as interpreted by qualified personnel (e.g., veterinary pathologists).

8. The sample size for the training set

• This is not applicable for a non-AI medical device submission.

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

• This is not applicable for a non-AI medical device submission.

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Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula.

Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is

The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

Here's an analysis based on the provided 510(k) summary for Norian Reinforced and Norian Reinforced Fast Set Putty:

Key Takeaway: This 510(k) summary is for a medical device (bone cement), not an AI/ML powered device. Therefore, many of the requested sections related to AI/ML specific evaluation criteria (e.g., sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The "study" here refers to a comparative non-clinical study against predicate devices, focusing on material properties and biocompatibility.

Acceptance Criteria and Study Details (Non-AI/ML Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a bone cement, the "acceptance criteria" are related to its physical properties, biocompatibility, and intended use as compared to predicate devices. The document doesn't provide specific quantitative tables for acceptance criteria and performance values in the way one would for an AI model. Instead, it states that the device meets the requirements through comparative testing.

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

• Sample Size: Not specified in the provided summary. This would refer to the number of material samples tested for mechanical, in-vitro, and biocompatibility assessments.
• Data Provenance: Not specified, but generally, such tests are conducted in laboratories following specific standards (e.g., ISO, ASTM). The data would be from controlled laboratory experiments, not patient data.

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

• Not Applicable. This is a medical device (bone cement) undergoing non-clinical testing for material properties and biocompatibility, not an AI/ML system requiring expert-based ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this doesn't involve subjective human interpretation or diagnostic agreement typical of AI/ML evaluation. Performance is based on objective measurements against established material standards and comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a bone cement, not an imaging AI diagnostic aid. MRMC studies are not relevant for this type of device.

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

• Not Applicable. This is a physical medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Objective Material Science and Biocompatibility Standards: The "ground truth" for this device's performance is based on established scientific and engineering principles for material properties (e.g., strength, setting time), chemical composition, and biological response as defined by recognized standards (e.g., ISO 10993 for biocompatibility). The comparison point is often the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/ML model that requires a training set. The device formulation and manufacturing process are developed through R&D and engineering, not machine learning training.

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

• Not Applicable. As with point 8, there is no "training set" in the context of an AI/ML model for this type of device.

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Kryptonite Bone Cement™ is a resinous material for repairing cranial defects.

Kryptonite Bone Cement™ is a resinous material to be used as a cranial bone void filler. Kryptonite Bone Cement™ is a self-setting bone cement that is formed by combining and mixing three components, resulting in a mild exothermic polymeric reaction (less than body temperature) that polymerizes into a malleable putty and progresses to a hard cement-like complex. The three components of Kryptonite Bone Cement™ are a liquid pre-polymer isocyanate mixture, a liquid polyester polyol, and a powdered calcium carbonate.

The provided text describes the 510(k) summary for Kryptonite Bone Cement™, a medical device for repairing cranial defects. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and detailed device performance metrics in a tabulated format.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not extractable from the provided text as this is a regulatory submission for a bone cement, not an AI/software as a medical device (SaMD).

Here's an attempt to address the points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified for any of the tests. The document refers to "the entire ISO-10993 test battery" for biocompatibility and "animal studies in rabbits (e.g., calvarial defect study)" but does not quantify the number of samples or animals.
• Data Provenance: Not specified. Standard pre-clinical testing for medical devices is typically conducted in a controlled lab environment by the manufacturer or contracted labs.

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

• Not Applicable. This is a bone cement, not an AI/SaMD device requiring expert image review for ground truth. Ground truth for this type of device is established through physical, chemical, and biological measurements (e.g., material testing, histological analysis in animal studies).

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 bone cement, not an AI/SaMD device.

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

• Not Applicable. This is a bone cement, not an AI/SaMD device.

7. The type of ground truth used

• Material properties: Measured values from standardized tests.
• Biocompatibility: Results of standardized ISO-10993 tests (e.g., cytotoxicity, irritation, sensitization, genotoxicity, implantation).
• Mechanical properties: Measured values from static and dynamic mechanical tests.
• Animal studies: Macroscopic and microscopic histological evaluations by veterinary pathologists or histologists.

8. The sample size for the training set

• Not Applicable. This device uses traditional pre-clinical testing, not machine learning, so there is no "training set."

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

• Not Applicable. See point 8.

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PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not mention a specific "test set" in the context of clinical studies for performance comparison or data provenance. The performance similarities are based on comparative material property testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the submission details material property comparisons and biocompatibility testing, not a clinical study involving experts for ground truth establishment.

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

This information is not applicable.

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

This information is not applicable as this device is an artificial bone substitute, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as this is a medical device (bone substitute), not an algorithm.

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

For the material properties (doughing time, setting time, working time, pH, compressive strength, dissolution rate), the "ground truth" or reference was derived from established standards (e.g., ISO 7490:2000 for compressive strength) and comparison to a legally marketed predicate device. For biocompatibility, the ground truth was based on compliance with ISO 10993-1:2003 guidelines.

8. The sample size for the training set

This information is not applicable as this is a medical device (bone substitute), not a machine learning model requiring a training set.

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

This information is not applicable.

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