Search Results

ACTIFUSE ABX, ACTIFUSE SHAPE and ACTIFUSE MIS:

Actifuse™ 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 is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware and intervertebral disc space. 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.

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE:

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space. ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS: ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

Actifuse is a phase-pure, porous, silicate-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse is similar to human cancellous bone. After it is implanted, ACTIFUSE undergoes physiologically-mediated resorption and is replaced by natural bone

ACTIFUSE is osteostimulatory based upon in vitro studies that show cellular responses, such as metabolic activity and proliferation, are accelerated when compared to an identical that did not contain 0.8% silicon by weight..

ACTIFUSE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ACTIFUSE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses.

The Actifuse bone void filler is presented in multiple product variants:

ACTIFUSE ABX

ACTIFUSE ABX presents the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable aqueous gel carrier packaged in a wide-bore applicator. ACTIFUSE ABX is a sterile, single-use device available in volumes of 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml.

ACTIFUSE ABX is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood, autologous bone marrow aspirate, or autologous bone at the discretion of the surgeon.

ACTIFUSE MIS

ACTIFUSE MIS System is an ACTIFUSE ABX packaging configuration in which the ACTIFUSE ABX implant material is supplied in a sterile 7.5ml cartridge packed with ACTIFUSE ABX implant material is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ACTIFUSE SHAPE

ACTIFUSE SHAPE supplies the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ACTIFUSE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ACTIFUSE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca. P. O. H. Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

ALTAPORE MIS

ALTAPORE MIS System is an ALTAPORE packaging configuration in which the ALTAPORE implant material is supplied in a sterile 7.5ml cartridge is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ALATAPORE MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE

ALTAPORE SHAPE supplies the ALTAPORE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ALTAPORE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE SHAPE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone.

The provided document describes a 510(k) premarket notification for several bone void filler devices (Actifuse ABX, Actifuse MIS, Actifuse Shape; ALTAPORE, ALTAPORE SHAPE; ALTAPORE MIS) by Baxter Healthcare Corporation. The submission aims to expand the indications for use to include intervertebral disc space applications.

Crucially, the document explicitly states that "no additional non-clinical data was needed to support the expanded indications proposed in the current submission" because "the subject device is identical to the previously cleared primary predicate device (K232315)." This means that the current submission relies entirely on the performance data of the predicate device (Catalyst Bone Void Filler, OssDsign AB, K232315) and existing reference devices (Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575; Altapore, Baxter, K192363; Altapore Shape, Baxter, K200640; Altapore MIS, Baxter, K201464).

Therefore, I cannot provide detailed acceptance criteria or study results for the currently submitted devices directly from this document, as no new performance testing specific to this submission's expanded indication for these devices is reported. The information requested below would typically come from the original 510(k) submission for the predicate device (K232315) or the reference devices.

However, I can extract the available information as specifically related to this submission's approach to demonstrating substantial equivalence.

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

As stated above, no new performance data or acceptance criteria are provided in this specific submission for the expanded indications. The submission argues for substantial equivalence based on the device being identical to a predicate (K232315) and similar to reference devices (K082575, K192363, K200640, K201464).

Acceptance Criteria (Implicit via Substantial Equivalence to Predicate): The device is considered to meet acceptance criteria if its technological characteristics, intended use, and performance are substantially equivalent to the cleared predicate and reference devices, implying it is as safe and effective.

Reported Device Performance:
The document describes the characteristics and prior in vitro/in vivo findings of the devices, which would have supported their initial clearances, but does not present new performance test results against new acceptance criteria for the expanded indication.

• ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS:
  • Osteostimulatory: Based on in vitro studies showing accelerated cellular responses (metabolic activity and proliferation) compared to an identical product without 0.8% silicon by weight.
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses.
• ALTAPORE, ALTAPORE SHAPE, ALTAPORE MIS:
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone.

The remaining points cannot be fully addressed from the provided text for this specific K-submission, as it explicitly states that no additional non-clinical data was needed. This implies that the current submission relies on previous data and FDA's prior determinations of substantial equivalence for the predicate and reference devices.

To answer points 2-9, one would need to access the original 510(k) submissions for:

• Primary Predicate: Catalyst Bone Void Filler, OssDsign AB, K232315
• Reference Devices:
  • Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575
  • Altapore, Baxter, K192363
  • Altapore Shape, Baxter, K200640
  • Altapore MIS, Baxter, K201464

Without those specific predicate/reference 510(k) summaries, I cannot provide the requested details regarding sample sizes, data provenance, ground truth establishment, or specific study methodologies.

Summary based on information provided for the current K241564 submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A: No new test set data was reported as needed for this submission. Reliance on previously cleared predicate (K232315) and reference devices (K082575, K192363, K200640, K201464).

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)
* N/A: No new ground truth establishment reported as needed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A: No new test set reported as needed for this submission.

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
* N/A: This device is a bone void filler, not an AI/imaging device, so MRMC studies are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A: No new ground truth reported as needed for this submission. However, for the original clearances of the predicate/reference devices, the descriptions mention "radiographic, histopathological, histomorphometric, and mechanical analyses" in animal studies, which serve as forms of ground truth for osteoconductivity.

8. The sample size for the training set
* N/A: This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
* N/A: Not applicable for a physical medical device.

Ask a specific question about this device

Actifuse 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 is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral 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™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute:

Based on the provided document (K071206), the review process for Actifuse™ ABX E-Z-fil Putty was a 510(k) Premarket Notification. This regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove newfound safety and effectiveness.

Therefore, the document does not contain the typical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be seen in a study evaluating a diagnostic or AI-driven device. Instead, the "acceptance criteria" are related to demonstrating that the new device is as safe and effective as its predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This information is not provided in the document. As a 510(k) submission primarily relies on demonstrating substantial equivalence through existing data on predicate devices and bench testing, detailed clinical "test sets" with patient data (e.g., country of origin, retrospective/prospective) are typically not included in this summary unless new clinical data was specifically required, which is not indicated here. The document mentions "bench testing," implying laboratory-based studies.

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

This information is not applicable/provided. Since the evaluation was based on demonstrating substantial equivalence primarily through technical characteristics and bench testing against standards, there's no mention of experts establishing a "ground truth" for a clinical test set in the context of diagnostic device validation.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. No clinical test set requiring adjudication in the context of expert consensus (like for imaging studies) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The device is a bone void filler, a physical medical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the "safety and effectiveness" claim, the ground truth was based on:

• "Relevant standards for Calcium Salt Bone Void Fillers": This implies adherence to established industry or regulatory standards for material properties, biocompatibility, mechanical performance, etc.
• "Bony infiltration of the porous scaffold": This likely refers to in vitro or in vivo (animal) studies demonstrating the biological activity of the material in promoting bone ingrowth, assessed perhaps through histological analysis or imaging.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The concept of a "training set" is typically associated with machine learning or AI algorithms. For a physical medical device like a bone void filler, product development involves material science, engineering, and biological testing, rather than an AI training/testing paradigm.

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

This information is not applicable/provided for the reasons stated in point 8.

In summary, the provided document for K071206 describes a 510(k) premarket notification for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a predicate device through shared technological characteristics, intended use, and bench testing against established standards, rather than clinical trial results with specific performance metrics (like sensitivity, specificity) for a diagnostic tool or AI algorithm.

Ask a specific question about this device