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

Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Cerasorb Ortho Foam device:

This document is a 510(k) premarket notification for a medical device called Cerasorb Ortho Foam. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" and "study" described here are focused on demonstrating substantial equivalence to a predicate, not necessarily meeting a specific performance metric in a standalone sense.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (Animal Study): The document states "A comparative study in sheep using the critical size defect model was performed." It does not specify the exact number of sheep used (sample size) or the number of defects created/treated.
• Data Provenance: The study was "in sheep," which indicates animal data. The location of the study (country of origin) is not explicitly stated in this document but implied to be part of the manufacturer's (curasan AG, Germany) activities. It is a prospective animal study designed for comparison.

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

• The document does not mention the number of experts used or their qualifications for establishing ground truth in the animal study. The evaluation focused on "amount and quality of newly formed bone" and "occurrence of fibrosis and inflammation," which would typically involve histological analysis and potentially expert pathology assessment, but specifics are omitted.

4. Adjudication Method for the Test Set:

• The document does not provide details on an adjudication method. It simply states that bone formation, fibrosis, and inflammation were "evaluated." This suggests standard scientific evaluation by the researchers involved in the study, but no formal adjudication process with independent experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) evaluating medical images or cases with and without AI assistance to measure improvement in diagnostic performance. The Cerasorb Ortho Foam is a physical bone void filler, not an AI software device.

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

• This question is not applicable. Cerasorb Ortho Foam is a physical medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• For the animal study (test set): The ground truth was established through histological evaluation of the amount and quality of newly formed bone, and the occurrence of fibrosis and inflammation at the surgical site in the sheep. This is a form of direct biological/pathological assessment.

8. The Sample Size for the Training Set:

• This question is not applicable. Cerasorb Ortho Foam is a physical medical device. It does not involve a "training set" in the context of machine learning or AI. The product's development would have involved various material science and biological compatibility tests, but not a dataset for training an algorithm.

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

• This question is not applicable, as there is no "training set" for this type of device.

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Cerasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.

This document is a 510(k) summary for a line extension to Cerasorb™ ORTHO, a bone void filler. It describes a modification to the device, changing its form from granular to additional block shapes. The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a clinical study in the way one might typically describe for a software-as-a-medical-device (SaMD) or diagnostic device.

The provided text focuses on:

• Device Identification: Cerasorb™ ORTHO Bone Void Filler.
• Predicate Devices: Cerasorb™ ORTHO (granular form), ChronOs, Viitoss Scaffold Synthetic.
• Device Modification: Change in size/geometry from granular forms to additional block forms (wadge, cylinder, cube, parallelepiped) up to 30cc, while maintaining the same Beta-Tricalcium Phosphate material with interconnecting porosity and introducing macropores mechanically.
• Intended Use: As a bone void filler in the skeletal system for voids/gaps not intrinsic to bony structure stability, to be gradually resorbed and replaced with bone, and mixed with autologous blood (same intended use as the predicate).
• Technological Comparison: Stating that all design modifications consist of the same pure phase Beta-Tricalcium Phosphate ceramic material (ASTM F 1088-87), porous, osteoconductive, and resorbable.
• FDA Substantial Equivalence Determination: The FDA letter confirms the device is substantially equivalent to the predicate, allowing it to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this information is not present in the provided document. The 510(k) process for this type of device (a material-based implant with a geometry change) typically relies on demonstrating material equivalence, manufacturing controls, and potentially biocompatibility, rather than a clinical performance study with defined acceptance criteria and statistical endpoints in the manner described by the prompt's questions.

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Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.

Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and substituted by vital, natural bone.

Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.

When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.

Here's an analysis of the provided text regarding the Cerasorb ORTHO Synthetic Bone Void Filler, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the subject device. As such, information typically found in a standalone clinical trial report (like detailed sample sizes for test sets, ground truth methodology for training, MRMC studies, or detailed performance metrics against specific acceptance criteria) is generally not present here. The performance is largely inferred from its similarity to the predicate device and general material properties.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for Cerasorb ORTHO are implicitly derived from its substantial equivalence to the predicate device, Vitoss™ Scaffold Synthetic. The following table summarizes the key performance attributes that indicate equivalence rather than explicit numerical acceptance criteria.

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