(132 days)
ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine 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 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.
ALTAPORE 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 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.
The provided text describes the Baxter Healthcare Corporation's ALTAPORE device, a resorbable calcium salt bone void filler, and its 510(k) premarket notification (K192363). The information focuses on the substantial equivalence to a predicate device and clinical performance.
However, the provided text does not contain the detailed information required to fill out a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. This is because the document is a 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with specific acceptance criteria and outcome metrics for a novel AI/device.
Specifically, the document does not include:
- A table of acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or other performance metrics).
- Any information regarding the use of AI in the device. The device described, ALTAPORE, is a physical medical device (bone void filler), not a software or AI-driven diagnostic tool.
- Sample sizes for a test set as would be used for an AI/software performance study.
- Data provenance (country, retrospective/prospective) related to AI study data.
- Number/qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance details.
- Ground truth type beyond "successful fusion based on CT scans".
- Training set sample size or how ground truth for training was established, as this is not an AI/ML device.
Therefore, it is not possible to answer the request using only the provided text. The text pertains to a physical medical device (bone void filler) and its regulatory clearance process, not a device that involves AI/ML and associated performance studies as outlined in the prompt's request for acceptance criteria and study proof.
The document does mention a clinical study for ALTAPORE:
Clinical Performance Testing:
- Study Design: A single-arm, prospective clinical study.
- Population: Patients with degenerative disc disease, spondylolisthesis, or spinal stenosis undergoing Posterolateral Fusion (PLF) surgery with ALTAPORE.
- Primary Endpoint: Solid fusion at postoperative month 12, assessed using computed tomography (CT) scans, with motion assessed using flexion-extension radiographs.
- Clinical Outcomes: Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores, and neurological assessments.
- Adverse Events: Recorded.
- Per Protocol Population (N): 102 for the primary endpoint evaluation.
- Results:
- Successful fusion: 59/89 (66.3%) at month 6, 88/102 (86.3%) at month 12 (primary endpoint), and 87/96 (90.6%) at month 24.
- Improved disability and pain, maintained neurological function.
- Adverse events: 43 (33.3%) of 129 patients experienced AEs; back pain most frequent (n=10); 9 and 14 patients experienced SAEs related to device and procedure, respectively.
While these are performance metrics for a medical device, they are not framed as "acceptance criteria" for an AI/ML model's output in the way the prompt implies (e.g., sensitivity, specificity thresholds). The study described is a clinical trial to demonstrate safety and effectiveness, as required for a physical medical implant.
§ 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.