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510(k) Data Aggregation
(27 days)
FIBERGRAFT™ BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler. FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFT™ AERIDYAN™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ AERIDYAN™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ AERIDYAN™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT™ AERIDYAN™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.
FIBERGRAFT™ BG Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine.
FIBERGRAFT™ BG Putty GPS is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty GPS is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material. FIBERGRAFT™ BG Putty GPS is to be provided in a spindle drive syringe and is compatible with the GPS Cannula product.
FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.
FIBERGRAFT™ AERIDYAN™ Matrix product is composed of 45S5 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the AERIDYAN™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.
FIBERGRAFT BG Matrix product is composed of 45S5 bioactive glass components (M-45 granules, MS-45 microspheres) and bovine type I collagen. The BG Matrix after hydration with saline, blood, or bone marrow aspirate (BMA) can be applied to the defect site or can be molded into the desired shape and gently packed into the defect site as a non-setting putty. In the posterolateral spine fusion applications, the product is intended to be hydrated with BMA and mixed with autograft in a 1:1 ratio.
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(26 days)
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser.
GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide.
The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.
Based on the provided FDA 510(k) clearance letter for "GPS Advanced and GPS Advanced Cannula," it's important to understand that this device is a piston syringe used for delivering a bone graft substitute. As such, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are focused on the mechanical and functional performance of the syringe as a medical device, rather than the performance of an AI/ML algorithm or diagnostic tool.
Therefore, many of the typical questions asked about AI/ML device studies (like MRMC studies, standalone algorithm performance, AI training/test sets, ground truth establishment for AI) are not applicable to this type of device.
Here's a breakdown of the acceptance criteria and performance data as inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Biological Safety | Biocompatibility and safety of materials in contact with body fluids/tissue. | Met through Biological Risk Assessment. |
| Sterilization Efficacy | Device is sterile. | Met through Sterilization Validation (Irradiation for GPS Advanced, Ethylene Oxide for GPS Advanced Cannula). |
| Packaging Integrity | Packaging maintains sterility and protects device integrity over shelf-life. | Met through Packaging and Shelf-Life Testing. |
| Functional Performance | Device delivers the intended substance (FIBERGRAFT™ BG Putty GPS) effectively and reliably to the bone grafting site. | Met through functional evaluation (likely as part of Packaging and Shelf-Life Testing, and implicitly through similarity to predicate). The ratcheted plunger advances with each squeeze, allowing delivery. |
| Shelf-Life Stability | Device maintains its functional and sterile properties for its specified shelf-life. | Met through Shelf-Life Testing. |
| Design & Material Conformity | Design features, materials, and principle of operation are consistent with predicate devices and suitable for intended use. | "The technological characteristics, including design, materials, principle of operation and performance as well as intended use of GPS Advanced and GPS Advanced Cannula are consistent with those of the primary predicate and reference device." |
Explanation of Inferences:
- The document explicitly states that "The performance data for the subject devices consists of the following evaluations: Biological Risk Assessment, Sterilization Validation, Packaging and Shelf-Life Testing, including functional evaluation." These evaluations implicitly define the acceptance criteria for those aspects.
- The statement about "consistent with those of the primary predicate and reference device" implies that the new device must perform comparably to previously cleared devices in terms of its core technological characteristics and function.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly detailed in the provided 510(k) summary. For a mechanical device like a syringe, "sample size" typically refers to the number of units tested for various validations (e.g., how many syringes were subjected to sterilization, packaging, or functional tests). The document does not specify these numbers.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to test results from various engineering and biological validations of the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this device. "Ground truth" in this context is established through engineering specifications, validated test methods (e.g., sterility testing, material biocompatibility standards), and direct functional testing, not by expert consensus on clinical images or interpretations.
4. Adjudication Method for the Test Set
This concept is not applicable to this device, as there's no "interpretation" or "diagnosis" being made that requires human adjudication. Device performance is determined by objective measurements and validation against established standards.
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 was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The GPS Advanced and GPS Advanced Cannula is a delivery device, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms that perform a task independently (e.g., detecting a lesion on an image). The GPS Advanced and GPS Advanced Cannula is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective scientific and engineering standards and tests:
- Sterility Validation: Demonstration that the device meets established sterility assurance levels (e.g., SAL of 10^-6).
- Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility.
- Functional Specifications: Ability to successfully deliver the specified volume of material, maintain pressure, resist leakage, and operate smoothly.
- Packaging Integrity Standards: Ability of the packaging to maintain sterility and physical integrity under specified conditions.
- Shelf-Life Parameters: Demonstration that the device retains its functional and sterile properties over its specified shelf-life.
8. The Sample Size for the Training Set
This concept is not applicable for this device. "Training set" refers to data used to train AI/ML algorithms. The GPS Advanced and GPS Advanced Cannula is a mechanical device, not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for this device, as there is no "training set" in the AI/ML sense.
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(51 days)
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS. The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation. GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.
The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to performance with AI.
The document is a 510(k) premarket notification for a medical device called "GPS Advanced; 5 cc GPS Advanced Cannula," which is a dispensing system for a bone graft substitute. The review focuses on the substantial equivalence of this device to legally marketed predicate devices, primarily regarding its mechanical and material characteristics, sterility, usability, and packaging.
The relevant section, "H. Performance Data," lists the following evaluations:
- Biological Risk Assessment
- Sterilization Validation
- Usability Engineering Evaluation
- Packaging and Shelf Life Testing, including functional evaluation
These are standard engineering and safety tests for a medical device that does not involve AI.
Therefore, I cannot provide the requested information regarding acceptance criteria for AI performance or a study demonstrating such performance.
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(103 days)
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
The FIBERGRAFT™ BG Putty is a osteoconductive, resorbable, biocompatible bone graff substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable binder to form a cohesive material.
The provided document is a 510(k) Summary for the FIBERGRAFT™ BG Putty Bone Graft Substitute. It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices. However, this document does not contain a table of acceptance criteria or details of a study that directly proves the device meets specific performance acceptance criteria in the format requested.
Instead, it evaluates the device against predicate devices and relies on animal studies and biocompatibility testing. I will extract the available information as best as possible to answer your questions, but many points will be marked as "Not provided" or inferred from the context of a 510(k) submission.
Here's the breakdown of the information based on your request:
1. A table of acceptance criteria and the reported device performance
A specific table of acceptance criteria with numerical targets and corresponding device performance is not provided in the document. The document states that performance was evaluated and found "substantially equivalent" to predicate devices, and that the device "performs as safely and as effectively as the predicate device."
The closest statements to performance attributes are:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Physical and Chemical Properties: In vitro functionality and bioactivity. | Confirmed in vitro functionality and bioactivity. (No specific numerical results provided). |
| Biocompatibility: Meets ISO 10993 standards. | Demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. |
| Functional Performance (In vivo): Evidence of new bone formation in critical size defects, substantially equivalent to predicate device. | "Animal testing demonstrated evidence of new bone formation in critical size defects, with substantially equivalent performance compared to the predicate device... The results of the study demonstrated that the BG Putty device performs as safely and as effectively as the predicate device, and any differences between the results of the device groups do not raise new types of safety or effectiveness concerns." (No specific quantitative metrics for bone formation or equivalence provided). |
| Packaging, Shelf Life, Aging: Passing results. | Packaging evaluations, shelf life testing and real-time aging testing were performed with passing results. |
| Safety and Effectiveness: Functions as intended without raising new safety or effectiveness concerns compared to predicate. | "Performance testing demonstrated that the BG Putty device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate devices." "The minor technological differences between BG Putty and its predicate devices do not raise any new issues of safety or effectiveness. Performance data demonstrate that BG Putty is equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: The document mentions a functional performance animal study: "A total of 58 tested samples were evaluated in the study from skeletally mature sheep." This refers to samples within the study, not necessarily individual animals.
- Data provenance:
- Country of origin: Not provided.
- Retrospective or prospective: The animal study described is a prospective study by its nature, designed to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This device is a bone graft substitute, and its performance is evaluated in an animal model using objective measures (radiographic, histological, histomorphometric, and biomechanical data), not by expert interpretation of images or clinical assessments in a human study that would typically require independent expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As noted above, this is an animal study with objective measurements, not a human clinical trial requiring adjudication of interpretations.
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/Not provided. This is not an AI/imaging device. It's a bone graft substitute.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. See above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the "ground truth" equivalent would be the objective measurements obtained from the ovine model:
- Radiographic data
- Histological data
- Histomorphometric data
- Biomechanical data
These are direct measurements of biological and mechanical responses to the implant.
8. The sample size for the training set
Not applicable/Not provided. As this is a material science and biological response evaluation for a bone graft substitute, there is no "training set" in the context of machine learning algorithms. The development of the material itself would involve R&D and iterative testing, but not a "training set" in the requested sense.
9. How the ground truth for the training set was established
Not applicable/Not provided. See above.
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