(134 days)
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine).
ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender 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 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, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate and reference devices, outlining the device's composition, intended use, and nonclinical testing.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical study with primary endpoints. Instead, the "acceptance criteria" are implied by the various nonclinical tests performed to demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is the conclusion that the device met these implied criteria, making it substantially equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterility: Achieve a 10-6 Sterility Assurance Level (SAL) via radiation sterilization. Package integrity maintained. | Sterility: The device is sterilized with radiation, and the minimum sterilizing dose (MSD) for a 10-6 SAL was established and validated as described in ANSI/AAMI/ISO ISO 11137-2. Package Verification testing (Visual Inspection, Seal Strength, Bubble Leak testing) supports sterility. |
| Shelf Life: Maintain stability and performance over time, ideally matching or exceeding predicate/reference devices. | Shelf Life: A shelf life claim of 5 years is substantiated by stability results of the reference device ACTIFUSE SHAPE (K082575), as stability-indicating parameters are identical due to shared materials and packaging. |
| Performance - Bench: Demonstrate bioactive and osteoconductive properties, and similar physical structure/porosity to predicate. | Performance - Bench: No additional bench testing was conducted as the microgranule phase has identical chemical composition, physical structure, and manufacturing process to the predicate (K181225), and the carrier phase is identical to the reference device (K082575). Previous verification/validation testing for K181225 and K082575 are considered applicable. In vitro studies from the predicate submission evaluated bioactive properties (forming a surface apatite-layer in simulated body fluid). |
| Performance - Animal (Effectiveness): Demonstrate effectiveness for use in posterolateral fusion and extremities. | Performance - Animal: A preclinical animal study evaluated effectiveness for use in posterolateral fusion (with autogenous iliac crest bone graft (ICBG)). Another preclinical animal study assessed effectiveness for use in extremities (with and without autologous blood). The text states that "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." |
| Biocompatibility: Meet ISO-10993-1 and FDA guidance recommendations for biological safety. | Biocompatibility: Assessments were conducted based on ISO-10993-1 and FDA guidance. Testing included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen, Genotoxicity, and Implantation. The components of Altapore Shape (hydroxyapatite microgranule and alkylene oxide copolymer carrier) have been used in previously cleared predicate/reference devices with the same intended use and contact duration. |
| Substantial Equivalence: All non-clinical data demonstrates the device is substantially equivalent to predicates. | Substantial Equivalence: The non-clinical data demonstrates that the subject device is substantially equivalent and performs comparably to the predicate and reference devices for the same intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to preclinical animal studies for performance testing. However, it does not provide details on the sample size for these animal studies.
The provenance of the data (e.g., country of origin) is also not specified. The studies appear to be prospective in nature, as they were conducted to evaluate the device's performance.
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)
This information is not provided in the document. The animal studies involved radiographic, histopathological, histomorphometric, and mechanical analyses, which would typically involve expert interpretation. However, the number and qualifications of these experts are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication methods for the test set. Animal study results would typically be analyzed by the study researchers.
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. This document describes the clearance of a medical implant (bone void filler), not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As stated above, this is an implantable medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal performance studies, the "ground truth" (or evidence of performance) was established through:
- Radiographic analyses
- Histolopathological analyses
- Histomorphometric analyses
- Mechanical analyses
These are objective measures of bone healing and integration in animal models.
For biocompatibility, the ground truth was based on the results of the specified in vitro and in vivo tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen, Genotoxicity, Implantation) as per ISO-10993-1 and FDA guidance.
8. The sample size for the training set
The document does not mention a "training set" as it pertains to AI/ML development. This is a traditional medical device submission based on substantial equivalence to existing devices and nonclinical testing.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of an AI/ML training set in the document.
§ 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.