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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. 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 macroand 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 docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations.
AI,TAPORE 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 bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.
Here's an analysis of the acceptance criteria and study information for the ALTAPORE device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for ALTAPORE primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantifiable acceptance criteria that are then met by performance metrics. The "acceptance criteria" here are implied by the comparison to predicate devices and the general safety and effectiveness requirements for bone void fillers.
| Acceptance Criteria (Implied) | Reported Device Performance (ALTAPORE) |
|---|---|
| Composition: Silicate-substituted calcium phosphate, composed of elements naturally found in bone (Ca, P, O, H, Si). | Reported: Silicate-substituted calcium phosphate, composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). |
| Physical Structure: Granules with porosity similar to cancellous bone. | Reported: Granules with a porosity similar to cancellous bone. |
| Nominal (Total) Porosity: Comparable to predicate. | Reported: 82.5 ± 2.5% (Predicate: 80.0 ± 2.5%, indicating comparable performance). |
| Strut Porosity: Microporous. | Reported: Microporous. |
| Sterility: Terminal irradiation. | Reported: Terminal irradiation. |
| Bioactivity: Forms a surface apatite-layer in simulated body fluid. | Reported: Bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid. |
| Osteoconductivity and Bony Healing: Achieves bony healing in a critical defect model, replaced by natural bone. | Reported: Osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone. |
| Biocompatibility: Meets ISO 10993-1. | Reported: Biocompatibility established in accordance with ISO 10993-1. |
| Safety and Effectiveness: As safe and effective as predicate devices. | Reported: Non-clinical testing included benchtop material characterization, dissolution, and mechanical; as well as in-vitro bioactivity. Critical size defect implantation in-vivo animal studies have demonstrated that ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone. Concluded to be as safe and effective, and performs as well or better than predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical count of subjects or defects. The text refers to "in vivo animal studies" and "critical size defect implantation in-vivo animal studies" but does not provide specific numbers for the animals or defects studied.
- Data Provenance: The studies mentioned ("in vivo animal studies") suggest prospective animal studies. The country of origin for the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The concept of human "experts" establishing ground truth for evaluating the device's performance in a diagnostic or interpretive context (e.g., radiologists interpreting images affected by AI) is not applicable to this device. ALTAPORE is a bone void filler, and its performance is assessed through objective biological and material properties, as well as animal studies. Evaluation methods mentioned include radiographic, histopathological, histomorphometric, and mechanical analyses, which typically involve trained professionals interpreting results, but not in the context of defining "ground truth" for a labeling or classification task.
4. Adjudication Method for the Test Set
- Not applicable in the context of this device's evaluation. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions during diagnostic AI evaluations. This device's evaluation relies on objective measurements and scientific analysis in animal models.
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 diagnostic AI tools where human readers are involved in interpreting medical images or data. ALTAPORE is a medical device (bone void filler), and its performance is not assessed through human reader interpretation of AI output.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system. It is a physical bone void filler. The "standalone" performance here refers to the device's inherent properties and biological interactions as assessed in in vitro and in vivo (animal) studies, without human intervention in its function. The studies evaluate the material itself.
7. The Type of Ground Truth Used
- The "ground truth" for evaluating ALTAPORE's performance in animal studies was established through a combination of objective scientific analyses:
- Radiographic analysis: Imaging confirming bone formation.
- Histopathological analysis: Microscopic examination of tissue to assess new bone growth and remodeling.
- Histomorphometric analysis: Quantitative microscopic analysis of tissue structures.
- Mechanical analysis: Testing the strength and integrity of the repaired bone.
- In vitro studies: Demonstrating apatite layer formation in simulated body fluid.
8. The Sample Size for the Training Set
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. ALTAPORE is a physical medical device, not an AI or algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, there is no "training set" for this device.
§ 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.