(115 days)
ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE may be used with autograft as a bone graft extender or bone marrow aspirate in extremities, and pelvis. ALTAPORE must be used in combination with autograft as a bone graft extender or autogenous bone marrow aspirate in posterolateral spinal fusion procedures. 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. ALTAPORE resorbs and is replaced with bone during the healing process.
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.
This document is a 510(k) premarket notification for the Baxter Healthcare Corporation's ALTAPORE device, a resorbable calcium salt bone void filler. It describes the device, its indications for use, and a comparison to predicate devices, along with non-clinical performance and biocompatibility testing.
Here's an analysis of the acceptance criteria and study information provided, focusing on the absence of information as well:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested. Instead, it describes performance through various animal and in vitro studies. The general acceptance criterion implied is that the device should demonstrate "similar performance in normal bone healing response" or "normal bone healing response... equivalent to the predicate device."
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| In Vitro Bioactivity | Formation of hydroxycarbonate apatite (HCA) layer | Forms a surface apatite layer when submerged in simulated body fluid. |
| Osteoconductivity (In Vivo Animal Studies) | Achieve bone healing in a critical defect model | Achieves bone healing in a critical defect model, confirmed with radiographic, histopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone. |
| Posterolateral Spinal Fusion (Animal Study) | Similar performance in normal bone healing response leading to spinal fusion | Similar performance to predicate in BMA and Autograft mixed groups. Evaluated by mechanical, radiographic, and histological examination. |
| Extremities Use (Animal Study) | Normal bone healing response equivalent to predicate device | Demonstrated normal bone healing response in extremities, equivalent to the predicate device (Actifuse ABX). Evaluated by decalcified histopathology, manual palpation, macroscopic assessment, plain radiography, non-histomorphometry, and biomechanical testing. |
| Biocompatibility | Meet ISO 10993-1 and FDA guidance for biological evaluation | All battery of tests (cytotoxicity, sensitization, irritation, system toxicity, genotoxicity/carcinogenicity/reproductive toxicity, implantation) were conducted. (Implied: met acceptance criteria as it wasn't flagged as a concern). |
2. Sample Size Used for the Test Set and Data Provenance
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Posterolateral Spinal Fusion (Animal Study):
- Sample Size: 182 New Zealand White Rabbits.
- Data Provenance: Prospective animal study (conducted with specific treatment groups and follow-up periods). Country of origin is not specified, but typically these studies are conducted in a controlled lab environment.
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Extremities Use (Animal Study):
- Sample Size: 39 sheep, creating 156 defects total.
- Data Provenance: Prospective animal study (conducted with specific treatment groups and assessment methods). Country of origin is not specified. This study was "previously carried out... as part of the secondary predicate submission (K130531)."
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In Vitro Bioactivity: The document does not specify a "sample size" in terms of number of samples tested, but implies that representative ceramic bone graft samples were tested in simulated body fluid.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- No human experts were used to establish ground truth for a test set in the context of device performance data. The studies described are preclinical animal studies (spinal fusion, extremities) and in vitro lab tests.
- The ground truth in these animal studies would be established through objective measures like:
- Radiographic imaging analysis (likely interpreted by veterinary radiologists or researchers).
- Histopathological and histomorphometric analysis (performed by veterinary pathologists or histologists).
- Mechanical testing (objective data).
- Manual palpation and macroscopic assessment (by researchers/veterinarians involved in the study).
4. Adjudication Method for the Test Set
- Since the described "test sets" are preclinical animal studies and in vitro tests, there is no human adjudication method in the sense of expert consensus for diagnostics.
- The assessment in animal studies is based on scientific methodologies and objective measurements. Any interpretation of results (e.g., radiography, histology) would typically involve trained personnel, but not an "adjudication panel" as seen in clinical studies for human diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No. This type of study was not done.
- The ALTAPORE device is a bone void filler, a physical implant, not an AI software device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. As stated above, this is a physical medical device, not an algorithm or AI software. There is no algorithm to perform in a standalone manner.
7. The Type of Ground Truth Used
- Preclinical Animal Studies (Spine and Extremities): The ground truth was established through a combination of:
- Histopathology: Microscopic examination of tissue (bone healing, integration, remodeling).
- Histomorphometry: Quantitative histological analysis.
- Radiography: X-ray imaging to assess bone formation and fusion.
- Mechanical Testing: Objective strength and biomechanical properties of the healed bone.
- Macroscopic Assessment and Manual Palpation: Visual and tactile evaluation of the surgical site.
- In Vitro Studies: The ground truth was based on objective chemical and material science measurements, such as the confirmed formation of hydroxycarbonate apatite (HCA).
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of AI development. The preclinical studies serve as verification and validation data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.