(97 days)
Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.
Merries UNI-OSTEO pellets are made of calcium sulfate (CaSO4). These pellets dissolve safely and completely in the body in approximately 30-60 days and resorption rate corresponds with new bone growth. The product is visible on radiographs so that the implant location can be easily identified and monitored. Merries UNI-OSTEO pellets are osteoconductive meaning that these pellets act as a scaffold and facilitate new bone growth.
This document describes the premarket notification for the Merries UNI-OSTEO Pellets Bone Graft Substitute. The acceptance criteria and the study proving it are primarily focused on biocompatibility and equivalence to predicate devices, rather than a typical AI/software performance study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-mutagenic, and compatible with surrounding tissues | Pass (for all individual tests listed below) |
| Cytotoxicity | (Implicitly: non-cytotoxic) | Pass |
| Intracutaneous Reactivity Test | (Implicitly: non-reactive) | Pass |
| Maximization Sensitization Test | (Implicitly: non-sensitizing) | Pass |
| Genotoxicity | (Implicitly: non-mutagenic) | Pass |
| Implantation | (Implicitly: compatible with surrounding tissues upon implantation) | Pass |
| Sterility | Sterile (determined by sterilization dose auditing) | (Implied: Supports sterility) |
| Material Conformance | Conforms to USP/NF "Official Monograph for Calcium Sulfate" | Conforms |
| Mechanical Strength | Equivalent strength to predicate device | Equivalent strength |
| Substantial Equivalence | Equivalence in base materials, function, and intended use to predicate devices | Substantially Equivalent |
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated for each biocompatibility test. The document states "Summaries and reports of all data are contained in the Premarket Notification Submission," which is not provided here.
- Data Provenance: The studies were conducted by Merries International Inc. (Taiwan, R.O.C.). The type of studies (e.g., animal models for implantation, in vitro for cytotoxicity) implies a mix of experimental data. Whether this data is considered "retrospective" or "prospective" is not applicable in the typical sense for these types of device tests; they are generally tests performed specifically for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable as this submission concerns a medical device (bone graft substitute) and its biocompatibility and material properties, not an AI/software device requiring expert interpretation of outputs for ground truth.
4. Adjudication Method
- Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools to assess human reader improvement, which is not the nature of this device.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical bone graft substitute, not a digital algorithm. The "standalone" performance here refers to its physical and biological properties.
7. Type of Ground Truth Used
- The "ground truth" for the tests performed can be characterized as:
- Biocompatibility Standards/Definitions: For tests like cytotoxicity, sensitization, and genotoxicity, the "ground truth" is defined by established scientific protocols and acceptable biological responses.
- Sterility Standards: For sterility, the "ground truth" is complete absence of viable microorganisms.
- Material Specifications: For material, the United States Pharmacopoeia (USP) National Formulary (NF) "Official Monograph for Calcium Sulfate" serves as the ground truth.
- Comparative Performance: For mechanical strength and substantial equivalence, the performance of the predicate devices (Osteoset™ Pellets and Jax™) serves as the "ground truth" or benchmark.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used.
§ 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.