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Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.

The provided text describes the device "Callos ProModel Bone Void Filler" and its regulatory clearance process, including summaries of non-clinical tests. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in human patients, as would be expected for a device with a focus on AI performance or clinical efficacy against measured outcomes.

Instead, the document states:

• "Callos ProModel does not meet the criteria to require clinical testing."
• "In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices."

This indicates that clearance was based on substantial equivalence to existing devices and non-clinical data, not on a clinical effectiveness study with defined acceptance criteria for patient outcomes.

Therefore, I cannot provide the requested table and information as the document does not contain the specific details about acceptance criteria, device performance against those criteria, or a qualifying clinical study.

Based on the provided text, the following points can be addressed, but the core request for acceptance criteria and a study proving their fulfillment cannot be fully met:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical effectiveness study in the provided text. The criteria are implied to be "substantial equivalence" to predicate devices based on non-clinical data (biocompatibility, bench testing, animal study).
   • Reported Device Performance:
     • "Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices."
     • "radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006."
     • "Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use." (Specific numerical performance metrics are not provided).
     • "The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use." (Specific outcome data or statistical comparisons are not provided).

2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" (human patient data) is described in the context of proving efficacy against acceptance criteria. The non-clinical studies involved bench testing (materials, mechanical properties) and an animal model. The sample size for the animal study is not specified, nor is the provenance of the animals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of clinical cases is described for establishing ground truth, as no clinical effectiveness study requiring such review was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical "test set" requiring adjudication by multiple experts is described.

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. The device is a bone void filler, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical implant, not a standalone algorithm.

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

   • For biocompatibility: Adherence to ISO standards.
   • For sterilization: Compliance with ANSI/AAMI/ISO standards.
   • For bench testing: Comparison to predicate device performance (implied physical/mechanical properties). The "ground truth" would be objective measurements of these properties.
   • For animal study: Biologic response compared to predicate devices in a large animal model. "Ground truth" would likely involve histological assessment, imaging, or gross observation of bone healing and integration in the animals, as interpreted by veterinary or pathological experts.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set. The "development" would involve material science and engineering, not machine learning.

9. How the ground truth for the training set was established: Not applicable.

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Callos Bone Void Filler is indicated to the following indications:
1 . To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2. To be used with autograft as a bone graft extender (i.e. extremities, and pelvis only).
Callos resorbs and is replaced by bone during the healing process.

Callos Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. The single-use Callos Kit contains the necessary components for mixing of the bone void filler. The Callos sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula).

The provided text is a 510(k) summary for the Callos® Bone Void Filler. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that specifically proves the device meets particular numerical performance criteria.

Instead, the summary focuses on demonstrating substantial equivalence to previously approved devices based on:

• Technological characteristics: Callos is composed of a calcium phosphate powder and a sodium silicate solution, which when mixed forms a paste that hardens into hydroxyapatite, similar to the mineral phase of native bone. Its function as a bone graft extender is similar to predicate devices.
• Biocompatibility: In accordance with ISO 10993-1.
• Sterilization validation: Compliant to ANSI/AAMI/ISO 11137-2.2006.
• Physical/mechanical characteristics: Evaluated using setting tests (modified ASTM) and X-ray Diffraction (XRD) phase analysis, and compared with predicate devices.
• Clinical use (for new indication): An "ewe study" (sheep study) demonstrated its use as an orthopedic bone graft extender.

Therefore, most of the specific questions about acceptance criteria, numerical performance, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance cannot be answered from the provided text, as these concepts are typically associated with performance evaluations of diagnostic or AI-based devices, not material equivalence for a bone void filler as presented here.

However, I can extract the specific information that is present regarding the device and its evaluation methods.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative acceptance criteria or device performance in the manner typically seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on material properties, biocompatibility, and functional similarity.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The "ewe study" is mentioned, indicating an animal (sheep) model in a prospective study design for the new indication as a bone graft extender. Other tests (biocompatibility, sterilization, physical/mechanical) are cited as having been performed previously for earlier Callos clearances (K030554 and K051123) and are standard laboratory evaluations. The location/country of origin is not specified.

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

Not applicable/provided. This type of detail is not required or typically included in a 510(k) summary for a bone void filler's substantial equivalence determination. The "ewe study" likely involved veterinary surgeons and pathologists, but specific numbers and qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable/provided. This is not relevant for the type of device and evaluation described.

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

No MRMC study was done. This type of study is typically for evaluating the performance of diagnostic imaging devices or CAD systems, not for a bone void filler.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the "ewe study," the ground truth for evaluating bone graft extension would likely involve histopathology (analysis of tissue samples under a microscope to confirm bone formation, resorption of the material, integration with host bone) and potentially radiographic imaging over time. For the physical/mechanical tests, the "ground truth" is defined by the standardized test methods (e.g., modified ASTM) and the material characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "ewe study" could be considered a "test set" for the expanded indication.

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

Not applicable. No training set is involved.

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Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Callos is a calcium phosphate bone void filler which can either be injected or digitally impacted into the targeted void. It is a single use only proudct.

The provided document K051123, a 510(k) Pre-Market Notification for the Callos™ Bone Void Filler, does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this submission is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not significantly affect the safety or effectiveness of the device. In this instance, the modification is described as a "modification in materials" for the Callos Bone Void Filler, which was previously cleared under K030554.

The submission states: "This Special 510(k) proposes a modification in materials for Callos, which was previously cleared under K030554 on May 20, 2003. The indications for use, technology, principle of operation, packaging, and sterilization parameters of Callos remain the same as in the predicate cleared 510(k)s. ... The proposed modification in materials, is not a substantial change or modification, and does not significantly affect the safety or efficacy of Callos."

Therefore, this specific document does not report on a study with acceptance criteria and device performance metrics because it relies on the previous clearance (K030554) for establishing substantial equivalence. The focus of this submission is on demonstrating that the change in material does not alter the fundamental safety and effectiveness profile already established for the predicate device.

To answer your request, one would need to refer to the original 510(k) submission (K030554) for Callos Bone Void Filler, as that is where clinical performance data and acceptance criteria would likely be presented, if required for that initial clearance. This current document (K051123) is an approval for a material modification, not an initial market clearance that would typically include such a study.

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Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar, and mental areas.

Callos CMF Bone Void Filler is an impactable and moldable single use, biocompatible calcium phosphate bone void filler, that remodels and is replaced by bone during the healing process. Callos CMF is packaged in various kit sizes (3cc, 5cc, and 10cc).

This submission is for a medical device (Callos CMF Bone Void Filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (such as sample sizes for test/training sets, ground truth establishment methods, number of experts, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable and are not present in the provided 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, technology, and product specifications for a bone void filler product. It does not involve any form of AI for image analysis or diagnostic support.

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Callos Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Callos Bone Void Filler is an injectable, moldable and biocompatible bone void filler. Callos Bone Void Filler resorbs and is replaced with bone during the healing process. The 3 cc, 5 cc, and 10 cc Callos Bone Void Filler kits are provided sterile and are for single use only.

The provided text describes the 510(k) summary for the Callos™ Bone Void Filler. This submission is for a medical device and not an AI/ML powered device, so many of the requested fields related to AI/ML specific studies (e.g., test set, ground truth methods, MRMC studies, training set details) are not applicable or extractable from this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and animal testing.

Here's the information that can be extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted to prove the device meets acceptance criteria is a series of non-clinical and animal tests, along with comparative testing against a predicate device. The primary goal was to demonstrate "substantial equivalence" to the legally marketed predicate device, Norian SRS Bone Void Filler (K011897).

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

• Sample Size for Test Set: Not applicable as this is a materials science and animal study, not an AI/ML study with a distinct "test set" of data samples in the same sense. The "test set" would encompass the various samples of the Callos Bone Void Filler material used for the non-clinical tests and the animals used in the in-vivo study. The exact number of material samples or animals is not specified in this summary.
• Data Provenance: Not explicitly stated, but the studies would have been conducted in a laboratory or animal testing facility context. The data is prospective as it was generated specifically for this submission.

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):

Not applicable. Ground truth for material properties, chemical analyses, and biocompatibility is established through standardized laboratory testing methods rather than expert consensus on diagnostic images. For the animal study, "ground truth" would be derived from the histological, chemical, crystallographical, and mechanical analyses performed by qualified scientists/pathologists, but the number and specific qualifications of these individuals are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies involving human readers and are not relevant for material science or animal studies of this nature.

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 submission for a bone graft substitute, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance was established through:

• Quantitative measurements from non-clinical laboratory tests (e.g., density, pH, setting time).
• Standardized analytical techniques (e.g., XRD, FTIR, elemental analysis) confirming material composition and structure.
• Biocompatibility assays conforming to recognized standards (e.g., for cytotoxicity, irritation).
• Histological, chemical, crystallographical, and mechanical analyses of animal tissues and implants to assess in-vivo resorption, bone ingrowth, and material behavior.

8. The sample size for the training set:

Not applicable. This is not an AI/ML powered device, so there is no training set in the context of machine learning.

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

Not applicable. There is no AI/ML training set.

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