(28 days)
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
This document describes a 510(k) premarket notification for CarriGen® PF, a resorbable calcium salt bone void filler device. The information provided demonstrates the device's substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and performance studies for an AI/ML medical device.
Specifically, this document does not describe:
- A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. The acceptance criteria mentioned are for the physical properties of a bone void filler.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML test set.
- MRMC or standalone studies for an AI/ML algorithm.
Therefore, I can only provide the information that is available in the document, which primarily pertains to the physical and chemical properties of the bone void filler, not an AI/ML device.
Here's an analysis of the provided text based on your request, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance (Based on Device Type - Bone Void Filler)
The document primarily focuses on the physical and chemical performance characteristics of the CarriGen® PF bone void filler, not an AI/ML algorithm.
1. A table of acceptance criteria and the reported device performance
The document states that "The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific acceptance criteria values and corresponding reported performance values. It only lists the types of performance testing conducted:
| Test Type | Description / Purpose | Reported Performance |
|---|---|---|
| Simulated Use/Extrusion Testing | Demonstrated the device's performance in a simulated use environment. | "Meets pre-determined acceptance criteria." (Specific values not provided) |
| Working Time | Time the material remains workable after mixing. | "Meets pre-determined acceptance criteria." (Specific values not provided) |
| Setting Time | Time for the material to harden. | "Meets pre-determined acceptance criteria." (Specific values not provided) |
| Compression Strength | Mechanical strength of the hardened material. | "Meets pre-determined acceptance criteria." (Specific values not provided) |
| Biocompatibility Evaluation | Ensures the material is safe for biological contact. | "Meets pre-determined acceptance criteria." (Specific values not provided) |
| Bacterial Endotoxin Test (BET) | To establish that the device meets pyrogen limit specifications. | "Meets pyrogen limit specifications." (Specific values not provided) |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The testing mentioned is for the physical and chemical properties of the material, not a data-driven AI test set.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified, as this is for material testing, not patient data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for AI/ML performance studies involving human expert interpretations of data (e.g., medical images). The document describes testing of a physical medical device.
4. Adjudication method for the test set
- Not applicable. This information is relevant for AI/ML performance studies involving multiple human readers.
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 document describes a traditional medical device (bone void filler), not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a traditional medical device (bone void filler), not an AI/ML software.
7. The type of ground truth used
- For material properties: The ground truth for the performance testing (e.g., working time, setting time, compression strength, biocompatibility, endotoxin levels) would be established by standardized testing methods and specifications (e.g., ASTM standards, ISO standards, USP monographs for biocompatibility and endotoxin). The "truth" is determined by the physical and chemical measurements aligning with the pre-defined acceptable ranges for these properties.
- For AI/ML: Not applicable in this document.
8. The sample size for the training set
- Not applicable. This document describes a traditional medical device (bone void filler), which does not have a "training set" in the context of an AI/ML algorithm. Its properties are inherent to its formulation and manufacturing process.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm is mentioned.
In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review of a physical medical device (a bone void filler). It details the device's indications for use, description, predicate devices, and the types of performance testing conducted to demonstrate substantial equivalence of its physical and chemical properties. It does not contain any information relevant to the development, testing, or performance of an artificial intelligence or machine learning-based medical 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.