(58 days)
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine 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. ALTAPORE SHAPE resorbs and is replaced with bone during the healing process.
ALTAPORE SHAPE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of ALTAPORE SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).
ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE 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.
The provided text describes the 510(k) premarket notification for the Altapore Shape device, which is a resorbable calcium salt bone void filler. The submission focuses on aligning the indications for use of Altapore Shape for posterolateral spinal fusion procedures with a previously cleared predicate device, Altapore (K192363).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results for this submission (K200640). Instead, it relies on the substantial equivalence to previously cleared predicate devices. The key "performance criterion" for this submission is demonstrating that the change in indications (specifically referring to its use in posterolateral spinal fusion as a stand-alone graft) does not alter the safety and effectiveness, leveraging prior studies.
However, the document mentions that for the initial clearance of Altapore Shape (K191513) and Altapore (K192363), various tests were conducted and met acceptance criteria. Based on the provided text, the relevant performance characteristics and implicitly met acceptance criteria are:
| Acceptance Criteria (Implied) | Reported Device Performance (Reference to K191513 and K192363) |
|---|---|
| Sterility: Achieve a 10-6 Sterility Assurance Level (SAL). | Established and validated at the manufacturing facility as described in ANSI/AAMI/ISO ISO 11137-2. Labels "Sterile". Package verification based on Visual Inspection, Seal Strength, and Bubble Leak testing. |
| Shelf Life: Maintain stability over time. | A shelf life claim of 5 years is substantiated by stability results presented under K191513. |
| Bioactivity: Forms a surface apatite-layer. | Bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid (contains same ion concentrations as human blood plasma). |
| Osteoconductivity and Bone Healing: Supports bone growth and is replaced by natural bone in a critical defect model. | Osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model, confirmed with radiographic, histopathologic, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone. This was demonstrated for Altapore Shape (K191513) and for Altapore (K192363) for posterolateral spine fusion, and these findings are leveraged here. |
| Biocompatibility: No adverse biological reactions. | Biocompatibility assessments (Cytotoxicity, Sensitization, Irritation, System Toxicity, Pyrogen, Genotoxicity, Implantation) were conducted based on ISO-10993-1 and FDA guidance for K191513 and are unchanged. |
| (For this submission) Equivalence of Posterolateral Spine Fusion Indication: Safe and effective for stand-alone use in posterolateral spinal fusion. | The preclinical animal study conducted for Altapore (K192363) on posterolateral spine fusion, which demonstrated effectiveness as a bone graft extender, is "presented again to support the performance of ALTAPORE SHAPE as a stand-alone graft substitute in posterolateral spinal fusion procedures." The hydroxyapatite granules are identical to ALTAPORE, and carrier phase differences do not alter therapeutic use or safety/effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of this 510(k) submission (K200640) for human clinical trials. The submission focuses on leveraging previous substantial equivalence.
- Animal Studies: A preclinical animal study was conducted to evaluate the effectiveness of Altapore (or similar material) for posterolateral spinal fusion. The sample size for this animal study is not specified in the provided text. The data provenance would be prospective (animal study) from wherever the animal studies were conducted (country of origin not specified).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the text. For animal studies, the "ground truth" (e.g., bone healing confirmation) would typically be established by veterinary pathologists or histomorphometrists.
4. Adjudication Method
This information is not provided in the text. For animal studies, typically, the assessment of outcomes (e.g., histopathology, radiological findings) is performed by qualified individuals, but a formal "adjudication method" like 2+1 or 3+1 among experts is usually not described in such summaries unless there's a specific need for it in complex interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text. This type of study is more common for diagnostic AI devices, not directly for a bone void filler material itself, especially in a 510(k) submission focused on material equivalence and a slight indication expansion based on prior animal data.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done through the preclinical animal study and the in vitro studies.
- In vitro studies: Demonstrated bioactive properties (apatite layer formation).
- Animal study: Evaluated effectiveness for use in posterolateral fusion. This study directly assessed the material's ability to achieve bone healing. While the exact details of how "performance" was measured (e.g., fusion rates, bone density) are not given, the study was conducted on the device material itself.
7. Type of Ground Truth Used
For the animal studies mentioned:
- Histopathology: Assessing tissue changes at a microscopic level.
- Histomorphometry: Quantitative analysis of tissue structure (e.g., amount of new bone formation).
- Radiographic analysis: Imaging techniques to visualize bone healing.
- Mechanical analyses: Testing the strength of the healed bone segment.
These methods collectively served as the "ground truth" to determine bone healing and fusion in the animal model.
8. Sample Size for the Training Set
The document does not mention a training set. This is because Altapore Shape is a medical device (a material), not an AI algorithm that requires a training set for model development. The performance is based on its material properties and biological interactions demonstrated in non-clinical studies.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set (relevant for AI), this question is not applicable.
§ 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.