(105 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 stability of the bony structure. These defects may be surgically created osseous defects or 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. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty 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 Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Here's an analysis of the provided text regarding the CarriGen Porous Bone Substitute Material, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" for CarriGen are implicitly tied to demonstrating substantial equivalence to its predicate devices (OssiPro, EquivaBone Osteoinductive Bone Graft Substitute, and Gamma-bsm Moldable Bone Substitute Material). The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds. Instead, it refers to "regression testing" as the method to demonstrate that changes do not affect the risk profile.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Substantial Equivalence to Predicate) | "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." |
| Intended Use Consistency | The stated intended use for CarriGen (filling bony voids/gaps in extremities, spine, pelvis; osteoconductive material that resorbs and is replaced by natural bone) aligns with the general characteristics of a bone void filler and is assumed to be substantially equivalent to the predicate devices' intended uses. |
| Material Composition Consistency | CarriGen's composition (Synthetic calcium phosphate, sodium carboxymethyl cellulose, sodium bicarbonate, and sodium carbonate) is presented, and its properties are described as similar to natural bone minerals and osteoconductive. This information implicitly supports consistency with the predicate device. |
| Physical and Chemical Properties (e.g., Conversion to apatitic calcium phosphate, Low crystalline order, osteoconductivity, resorption) | Described as: "harden at body temperature and convert 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 Carrier Bone Substitute Material is an osteoconductive material that resorbed and replaced by natural bone over time." This description supports the expected performance characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "regression testing" but does not provide details on the number of samples or cases used for this testing.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through "regression testing" against existing predicate devices and a guidance document, rather than clinical studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As no details about expert ground truth or a clinical test set are included beyond "regression testing," no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable and not provided. The device is a bone graft substitute material, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device is a physical bone graft substitute material, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/diagnostic device evaluation (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "proof" is based on demonstrating that modifications to an already cleared device (OssiPro) do not alter its safety or effectiveness, as assessed through "regression testing" against a guidance document and comparison to predicates. The implicit "ground truth" is that the predicate devices are safe and effective for their intended use.
8. The Sample Size for the Training Set
This information is not provided. The document describes a medical device, not an AI algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As explained above, this is a physical medical device, not an AI algorithm with a training set and associated ground truth establishment.
Summary of the Study:
The "study" described in this 510(k) submission is referred to as "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device."
- Purpose: To demonstrate that the proposed changes to the predicate devices (OssiPro, EquivaBone, Gamma-bsm) do not affect the risk profile of the devices, thereby maintaining substantial equivalence for the modified CarriGen Porous Bone Substitute Material.
- Methodology (as implied): The specific tests performed under "regression testing" are not detailed, but they would typically involve physico-chemical characterization, mechanical testing, biocompatibility evaluations, and potentially in-vitro or in-vivo studies to confirm that the modified material's properties (such as setting time, conversion to apatitic calcium phosphate, porosity, osteoconductivity, and resorption rate) remain within acceptable limits and are comparable to the predicate devices and the requirements of the Special Controls Guidance Document.
- Conclusion: The submission of this testing was deemed sufficient by the FDA to issue a substantial equivalence determination, implying that the CarriGen device met the unstated acceptance criteria embedded within the guidance document and the substantial equivalence pathway.
§ 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.