Search Results

A- GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX TE Resorbable Bone Void Filler may be used at an infected site.

The A-GRIX TE Resorbable Bone Void Filler consists of 1 bottle of pre-measured surgical grade calcium salt mixture and 1 bottle of mixing solution. When mixed according to the direction, A-GRIX TE forms the biodegradable, biocompatible and radiopaque paste or putty for digitally applying directly or by dispensing into the defect site. Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. This product is supplied sterile for single patient use.

This document describes a 510(k) submission for the A-GRIX TE Resorbable Bone Void Filler, a medical device. The information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical performance targets and a detailed study proving those targets are met.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not contain a table with specific numerical acceptance criteria for device performance (e.g., tensile strength, porosity, resorption rate) nor does it report specific performance values for the A-GRIX TE product against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device by stating:

• "The A-GRIX TE Resorbable Bone Void Filler has the same intended use and technological characteristics as the A-GRIX Resorbable Bone Void Filler (K091688) marketed by AG DIGITAL Technology Corp."
• "Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

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

The document mentions "bench testing" but does not provide details on the sample size used for this testing. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the full 510(k) submission, not in the provided summary.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document. The submission is for a material-based medical device (bone void filler), not an AI/software device that generates diagnostic outputs requiring expert ground truth for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is not established by expert consensus for this type of device.

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

Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

The "ground truth" for this device would be established through bench testing against recognized standards, and potentially in vivo or in vitro studies to assess biocompatibility, resorption, and osteoconductivity. The document lists conformity to:

• ISO 10993 series: Biological evaluation of medical devices
• ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Radiation Sterilization

These standards define the methodologies and expected outcomes for performance ("ground truth") related to a bone void filler's properties, biocompatibility, and sterility.

8. Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

Not applicable.

Ask a specific question about this device

The AG Thermographic Camera(Model no.: ATIR M301) is intended to use as an adjunct to other clinical diagnostic procedures by quantifying differences in skin surface temperature changes. It can visualize and digitalize body surface temperature distribution and temperature changes. The device is intended for use by qualified healthcare personnel trained in its use.

The AG Thermographic Camera (Model no.: ATIR-M301) consists of an infrared camera, accessories, and PC visualization/analysis software. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image.

This document describes the AG Thermographic Camera, Model no.: ATIR-M301, a telethermographic system.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The document lists performance tests conducted, implying these serve as acceptance criteria. The specific numerical acceptance criteria values are largely absent, except for temperature accuracy.

Ask a specific question about this device

A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.

The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules. Because of the special treated granules, the dissolving of A-GRIX Resorbable Bone Void Filler would be longer than other products and closer to the new bone formation. Besides, the different granule size could make it be easy to be filled into the bony defect. When mixed according to the directions, A-GRIX forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. A-GRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.

The provided text describes a 510(k) submission for the A-GRIX Resorbable Bone Void Filler, focusing on its substantial equivalence to a predicate device rather than a comprehensive study demonstrating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies is not explicitly detailed in the provided document.

Here's an analysis based on the available information:

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

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

The document does not detail specific sample sizes for a clinical test set. The performance is primarily based on conformance to material and biological standards, along with a claim of substantial equivalence to a predicate device. Data provenance is not specified beyond adherence to international and ASTM standards. The study appears to be "bench testing" and compliance with standards, not a clinical trial with a defined test set.

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

Not applicable. The submission focuses on substantial equivalence based on material properties and established standards, not on expert-adjudicated performance in a clinical setting.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication by 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. This device is a bone void filler, not an AI-assisted diagnostic or imaging tool.

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

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

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized standards: ISO 10993 (biocompatibility), ASTM F2224-03 (material composition), and ANSI/AAMI/ISO 11137 (sterilization).
• Bench testing: Demonstrating that physical and chemical properties are comparable to the predicate device.
• Predicate device's established safety and effectiveness: The A-GRIX device is deemed "substantially equivalent" to an already marketed device (Osteo-G bone void filler, K031319), which implies that its performance is expected to be similar to that device, whose safety and effectiveness would have been previously established.

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not a machine learning model requiring a training set.

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

Not applicable.

Ask a specific question about this device

CALTRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or created from traumatic injury to the bone. The pellets resorbs and is replaced with new bone during the healing process. When used in the spine, the device is limited to posterolateral fusion procedures only.

The CALTRIX Resorbable Bone Void Filler are made of high purity pharmaceutical grade calcium sulfate. It is bio-degradable, biocompatible and radiopaque pellets. CALTRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 14 weeks and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CALTRIX Resorbable Bone Void Filler, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria for performance beyond conforming to standards. It states the device "conforms to applicable standards." The "reported device performance" is primarily presented as meeting these standards and having similar performance characteristics to the predicate device.

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

The document mentions "bench testing contained in this submission." However, it does not specify any sample sizes for this testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). The study primarily relies on demonstrating conformity to existing standards and comparison to a predicate device.

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

There is no information provided in the text regarding the number or qualifications of experts used to establish a ground truth for any test set. The submission focuses on compliance with established material and sterilization standards, and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As there is no mention of a clinical test set or human-derived data analysis requiring adjudication, there is no information on any adjudication method.

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 section is not applicable. The device described is a medical implant (bone void filler), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This section is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's effectiveness and safety is primarily based on:

• Adherence to recognized industry standards: ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137.
• Demonstrated material properties: "high purity pharmaceutical grade calcium sulfate," "bio-degradable, biocompatible, and radiopaque pellets," "osteoconductive," "resorbed in approximately 14 weeks and be replaced by new bone."
• Substantial equivalence to a legally marketed predicate device: "Osteo-Link Bone Void Filler Pellets (K060809)." The performance and safety profile of the predicate device serves as an established baseline.

8. The Sample Size for the Training Set

There is no mention of a training set. This device is a physical product, not an AI model, and therefore the concept of a training set does not apply in this context.

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

As there is no training set, this question is not applicable.

Ask a specific question about this device