(233 days)
PRO-DENSE™ LoVisc Bone Graft Substitute is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. PRO-DENSE™ LoVisc Bone Graft Substitute resorbs and is replaced with bone during process.
PRO-DENSE™ LoVisc Bone Graft Substitute cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during process.
PRO-DENSE™ LoVisc Bone Graft Substitute is provided sterile for single use only.
PRO-DENSE™ LoVisc Bone Graft Substitute is a composite of calcium sulfate and calcium phosphate. The formulation consists of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.
Based on the provided text, the document describes a 510(k) premarket notification for a medical device called PRO-DENSE™ LoVisc Bone Graft Substitute. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the PRO-DENSE Bone Graft Substitute (K181255/K182823).
The information provided focuses on the non-clinical evidence used to support this claim of substantial equivalence. There is no mention of a study involving AI assistance, human readers, or image analysis. The device is a bone graft substitute, and its evaluation parameters are material properties and performance in a surgical context, not diagnostic accuracy based on algorithmic performance.
Therefore, many of the requested sections related to acceptance criteria for an AI/imaging device, MRMC studies, standalone AI performance, and expert ground truth establishment for diagnostic purposes, are not applicable to the content of this document.
Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Study for PRO-DENSE™ LoVisc Bone Graft Substitute
The provided text describes a 510(k) submission for a bone graft substitute, not an AI or imaging device. The "acceptance criteria" discussed are related to the material and mechanical properties of the bone graft substitute, demonstrating its equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied to be within the range of the predicate device's characteristics. The performance is reported in terms of chemical and mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Chemically equivalent to predicate | "The characterization testing showed that the subject material is chemically equivalent to the predicate" |
| Performs within the range of predicate | "the bench top testing showed the graft performs within the range of the predicates." |
| Specific physical/chemical properties consistent with predicate | Tested parameters listed below |
| Injectability consistent with targeted improved flow | "The additional liquid in the implant creates a bone graft material that can be more easily injected into bone voids." |
| Set Time consistent with new formulation | "The characteristics of the subject device are within the range of the predicate characteristics apart from set time and injectability." |
2. Sample Size Used for the Test Set and the Data Provenance
These concepts are not applicable in the context of this device and submission type. The "test set" refers to the samples of the PRO-DENSE™ LoVisc Bone Graft Substitute tested for its material properties. There is no mention of sample sizes for individual tests. The "data provenance" would refer to where the bone graft material was manufactured and tested, which is not specified beyond "Wright Medical Technology, Inc." in Memphis, TN. Data is from benchtop testing, not human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for a bone graft substitute is its inherent material properties and performance characteristics, measured through standardized assays (e.g., FTIR, XRD, mechanical testing). Experts would be involved in the design and interpretation of these bench tests, but not in establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in diagnostic studies. For material property testing, results are typically quantitative and objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states "(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A", meaning no human clinical studies were performed or are being presented for this submission. Therefore, no information on human reader improvement with AI assistance is available.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical bone graft substitute, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective, standardized benchtop testing of chemical and mechanical properties. This includes:
- Fourier Transform Infrared Spectroscopy (FTIR)
- X-ray Diffraction Analysis (XRD)
- Dissolution
- Porosity
- Density
- Maximum Exothermic Temperature
- Dilute Slurry pH
- Vicat and Gilmore Set Time
- Injectability
- DTS (unspecified, likely a material property test)
- Hardware interaction
- Sterilization
- Biocompatibility
- Pyrogenicity
- LAL testing
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This concept is 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.