(83 days)
PRO-DENSE™ resultant paste 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, spine, and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE™ paste 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 the healing process.
PRO-DENSETM is provided sterile for single use only.
PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or gently packed into bony defects.
Here's a breakdown of the acceptance criteria and study information for the PRO-DENSE™ Bone Graft Substitute, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim (based on in vivo canine model) | Reported Device Performance (vs. autograft at 13 weeks unless specified) |
|---|---|
| Claim 1: Stronger than autograft. Newly regenerated bone in PRO-DENSE™ treated defects should exhibit significantly increased compressive strength. | 645% average increase in compressive strength. |
| Claim 2: Denser than autograft. Newly regenerated bone in PRO-DENSE™ treated defects should demonstrate a statistically significant increase in new bone formation (area fraction). | 170% average increase in new bone volume/area fraction. |
| Claim 3: Faster than autograft. The accelerated rate of healing should be evident by higher density bone and superior mechanical properties. | 170% average increase in new bone volume. 645% increase in ultimate compressive strength and 600% increase in elastic modulus. |
| Claim 4: Remodels to normal bone. Newly regenerated bone should remodel to normal host bone, with normal trabecular architecture and no significant difference in mechanical properties at 26 weeks. | No statistically significant difference to normal bone area fraction at 26 weeks. No statistically significant difference in ultimate compressive strength and modulus of elasticity to normal bone samples at 26 weeks. |
| Claim 5: No modulus mismatch. The compressive modulus of newly regenerated bone at 13 and 26 weeks should fall within the published range for normal human cancellous bone. | Even the highest value measured for PRO-DENSE™ treated defects is well within the range of normal cancellous bone. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size for "test set" in terms of number of animals or defects. However, the study was conducted on a "critically sized canine proximal humerus defect model." This indicates an in vivo animal study.
- Data Provenance:
- Country of Origin: Not specified in the provided document.
- Retrospective or Prospective: Not explicitly stated, but in vivo animal studies like this are typically prospective in nature, with outcomes measured at defined time points (13 and 26 weeks).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The substantiation for the claims relies on objective measurements like ultimate compressive strength, elastic modulus, and histomorphometry for new bone volume/area fraction, rather than expert interpretation of images or clinical outcomes that typically require multiple expert adjudicators.
4. Adjudication Method for the Test Set
- This information is not applicable as the substantiation appears to be based on direct quantitative measurements (mechanical testing and histomorphometry) rather than subjective assessments requiring adjudication.
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
- An MRMC comparative effectiveness study was not done. This device is a bone graft substitute, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance study was not done. This device is a physical bone graft substitute, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth was established through objective biological and biomechanical measurements obtained from an in vivo animal model (canine proximal humerus defect). This includes:
- Ultimate compressive strength (mechanical testing)
- Elastic modulus (mechanical testing)
- Histomorphometry (measurement of new bone volume/area fraction, histological assessment of trabecular architecture)
8. The Sample Size for the Training Set
- This information is not applicable. The PRO-DENSE™ Bone Graft Substitute is a physical medical device, not an AI model that requires a training set. The study describes the performance of the device itself.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reasons as #8.
§ 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.