(28 days)
ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE MIS 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 are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.
Altapore MIS System is a 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 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 MIS System is supplied in a sterile 7.5ml cartridge 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 MIS System (hereafter referred to as "Altapore MIS) 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 MIS 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 MIS 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 MIS undergoes cell-mediated remodeling and is replaced by natural bone.
The provided text is a 510(k) summary for the Altapore MIS system, a medical device intended to fill bony voids. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or human improvement with AI assistance.
Therefore, many of the requested details about acceptance criteria for device performance, clinical study design, and ground truth establishment are not present in this regulatory document.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a table with specific quantitative acceptance criteria for clinical performance (e.g., bone healing efficacy percentage). Instead, it relies on demonstrating that the modifications to the device (new configurations, materials for applicator and cartridge) do not negatively impact the chemical, structural, and biological properties, and thus maintain the performance of the already cleared predicate devices.
The acceptance criteria are implicitly related to maintaining the performance demonstrated by the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Chemical Composition | "All testing confirmed that the new configurations had no impact to the chemistry or structure of the Altapore MIS System product." |
| Physical Structure | "All testing confirmed that the new configurations had no impact to the chemistry or structure of the Altapore MIS System product." |
| Biocompatibility | "All materials found in these devices that are the subject of this submission have been previously cleared under Baxter's 510(k) premarket notifications K192363... and K082575... Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for permanent duration, implant device, tissue/bone contact, and FDA Guidance..." |
| "ALTAPORE is non-pyrogenic based on material-mediated pyrogenicity testing conducted per ISO 10993-11 and bacterial endotoxin testing performed per USP." | |
| Sterility | "The Altapore MIS System product line is sterilized with radiation. The minimum sterilizing dose (MSD) required to provide a 10^6^ Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2..." |
| "Package Verification testing is based on Visual Inspection, Seal Strength, and Bubble Leak testing." | |
| Shelf Life | "Testing performed on representative samples supports a shelf-life claim of two (2) years for Altapore MIS." |
| Intended Use | "These modifications do not impact the intended use or the fundamental technology of the devices." |
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 "representative samples" for shelf-life testing and performance testing related to chemical changes. It also mentions "in vitro studies" and "in vivo animal studies" for the predicate device, but no specific sample sizes for these are provided within this 510(k) summary for the current device. The document explicitly states "The basis for this premarket notification is the addition of the Altapore MIS System configurations to the Altapore product line." and that the modifications "do not impact the intended use or the fundamental technology." This indicates reliance on existing data from predicate devices rather than new large-scale clinical studies for the new configuration.
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)
Not applicable. This is not a study involving expert interpretation of medical images or other diagnostic tests to establish ground truth for a test set. The validation is primarily technical (chemical, physical, sterility, shelf-life) and based on existing data for predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human reader adjudication for clinical interpretation is described.
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
Not applicable. This is not an AI-assisted diagnostic device, nor does the document describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device (from which the current device draws its equivalence), the document mentions:
- Bioactivity: "based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid..."
- Osteoconductivity: "based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histopathological, histomorphometric, and mechanical analyses."
For the current device modifications, the "ground truth" (or verification) is established through:
- Chemical analysis to confirm no change in chemistry or structure.
- Conformity to ISO standards (e.g., ISO-10993-1, ISO 10993-11, ANSI/AAMI/ISO 11137-2) for biocompatibility and sterility.
- USP for bacterial endotoxin testing.
- Package integrity tests (Visual Inspection, Seal Strength, Bubble Leak).
- Shelf-life testing on "representative samples."
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
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.