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510(k) Data Aggregation
(92 days)
Actifuse™ Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse™ Flow can be injected into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during process.
Actifuse™ Flow Bone Graft Substitute is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse 11d Flow Bone Graft Substitute can be injected into bony voids or gaps of the skeletal system. i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process.
Actifuse™ Flow is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure inherent of the source material for the mineral phase of Actifuse™ Flow is similar to human cancellous bone.
The medical device described in the provided text is Actifuse™ Flow, a resorbable calcium salt bone void filler. The submission is a 510(k) premarket notification for modifications to the product line, specifically applicator syringe design changes.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Acceptance Criteria | Reported Device Performance and Corresponding Test |
|---|---|
| 1. Chemical and Structural Integrity of Actifuse™ Flow | |
| Acceptance Criteria: The modifications to the applicator syringe should have no impact on the chemistry or structure of the Actifuse™ Flow product, ensuring it remains chemically and structurally identical to the predicate device. | Performance Data: The performance of the Actifuse™ Flow device after modifications made to the applicator syringe was assessed by analyzing the Actifuse™ Flow final product for chemical changes relative to the predicate product's specification. Result: "All testing confirmed that the modifications had no impact to the chemistry or structure of the Actifuse™ Flow product." |
| 2. Biocompatibility | |
| Acceptance Criteria: The device, including new materials, must meet biocompatibility standards for a permanent duration, implant device, tissue/bone contact. | Performance Data: Biocompatibility assessments were conducted based on ISO-10993-1, "Biological Evaluation of Medical Devices for permanent duration, implant device, tissue/bone contact," and FDA Guidance. Result: "All materials found in these devices that are the subject of this submission have been previously cleared under Baxter's 510(k) premarket notifications K082073 (clearance date September 11, 2008), K130531 (clearance date April 8, 2014) and K071206 (clearance date 31st May, 2007)." This indicates that the materials have already met biocompatibility standards. |
| 3. Sterility and Package Integrity | |
| Acceptance Criteria: The product must be sterile (10^-6 SAL) and remain sterile throughout its shelf life, with package integrity maintained. | Performance Data: "The Actifuse™ Flow product line is sterilized with radiation. The minimum sterilizing dose (MSD) required to provide a 10-6 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose."" "Package Verification testing is based on Visual Inspection, Seal Strength, and Bubble Leak testing." Result: "These products are labeled 'Sterile'." The implicit result is that the validation for sterilization and package integrity testing passed, supporting the "Sterile" claim. |
| 4. Shelf Life Stability | |
| Acceptance Criteria: The device must maintain its safety and effectiveness for a defined shelf life. | Performance Data: "Baxter has performed aging testing to support a shelf-life claim of two (2) years." Result: The implicit result is that the aging testing successfully demonstrated stability for a two-year shelf life. |
| 5. Overall Safety and Effectiveness (Substantial Equivalence) | |
| Acceptance Criteria: The modified device must be as safe and effective as the predicate device. | Performance Data: The entire submission, based on "Discussion of Non-Clinical Data," "Performance Data," "Biocompatibility," "Sterility," and "Shelf Life." Result: "The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device." "Actifuse™ Flow Bone Graft Substitute is as safe and effective as the predicate Actifuse™ Flow Bone Graft Substitute." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify sample sizes for any of the tests. It broadly mentions "All test results meet the acceptance criteria" and "All testing was performed on the configuration of the devices presented in this premarket notification." This suggests that the testing was conducted on a sufficient number of units to support the conclusions, but the exact count is not given.
The data provenance is pre-market notification testing conducted by Baxter Healthcare Corporation. The location of the testing is not explicitly stated, but Baxter Healthcare Corporation is based in Deerfield, Illinois, USA. The testing appears to be prospective in the sense that it was specifically performed for this 510(k) submission to demonstrate substantial equivalence of the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
There is no mention of experts or the establishment of "ground truth" using human experts for this specific submission. This is a non-clinical submission focused on material and design changes to an existing device, not a clinical study involving diagnosis or interpretation where expert consensus on "ground truth" (e.g., disease presence) would be relevant. The "ground truth" for this submission are the established specifications, chemical properties, and performance characteristics of the predicate device, against which the modified device is compared.
4. Adjudication Method for the Test Set
As this is a non-clinical submission, there is no adjudication method described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or other subjective data, to resolve discrepancies among readers/experts. These are not applicable to the chemical, physical, and sterility tests described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or imaging devices where human readers' performance with and without AI assistance is compared. This submission pertains to a physical medical device (bone void filler) with modifications to its applicator syringe, not an AI or imaging diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This question typically applies to AI algorithms. The device described is a physical medical product, not an algorithm. The "performance" assessment here relates to chemical, physical, and biological properties of the device itself, not an algorithm's output.
7. Type of Ground Truth Used
The "ground truth" used for this submission is based on established specifications, validated test methods, and existing regulatory clearances for the predicate device and the materials used. Specifically:
- Chemical/Structural Integrity: Ground truth is the defined chemical and structural properties of the predicate Actifuse™ Flow and its components.
- Biocompatibility: Ground truth is established biocompatibility standards (e.g., ISO-10993-1) and the successful prior clearance of the materials in other Baxter devices.
- Sterility: Ground truth is a 10^-6 Sterility Assurance Level (SAL) as established by international standards (ANSI/AAMI/ISO 11137-2).
- Shelf Life: Ground truth is the stability of a product over time, which is confirmed by specific aging tests.
Essentially, the ground truth is the established and acceptable performance of the predicate device and known standards, against which the modified device is compared.
8. Sample Size for the Training Set
There is no mention of a "training set" in this submission. Training sets are relevant for machine learning algorithms. This is a traditional medical device submission based on a direct comparison to a predicate device and engineering/material testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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