(259 days)
SIGNIFY™ Bioactive is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY™ Crunch is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). SIGNIFY™ Putty and Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). SIGNIFY™ resorbs and is replaced with bone during the healing process.
SIGNIFY™ Bioactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When SIGNIFY™ is placed in direct contact with host bone, new bone grows in apposition to the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by SIGNIFY™. SIGNIFY™ consists of Bioglass (per ASTM F1538), polyethylene glycol, and glycerol, and is available in putty, gel, and crunch forms to accommodate surgical and anatomical needs.
The provided text describes the SIGNIFY™ Bioactive device, a resorbable bone void filler. The submission is a 510(k) premarket notification, indicating that the device aims to demonstrate "substantial equivalence" to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate substantial equivalence to predicate devices. | "Performance data demonstrates substantial equivalence to the predicate devices." |
| As safe as predicate devices. | "SIGNIFY™ implants are as safe...as the predicate devices." |
| As effective as predicate devices. | "SIGNIFY™ implants are as...effective...as the predicate devices." |
| Perform as well as or better than predicate devices. | "SIGNIFY™ implants...perform as well as or better than the predicate devices." |
| In vivo performance in tibia defect model. | "In vivo performance testing (tibia defect model...) were conducted" |
| In vivo performance in posterolateral spine fusion model. | "In vivo performance testing (...and posterolateral spine fusion model) were conducted" |
| Biocompatibility testing in accordance with "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003. | "Biocompatibility testing were conducted in accordance with the 'Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device,' June 2, 2003." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the "in vivo performance testing" (test set). It only mentions that a "tibia defect model and posterolateral spine fusion model" were used.
The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies mentioned are "in vivo performance testing" which typically involve animal models or clinical trials, not expert review of retrospective data for ground truth establishment in the way it might be for an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The performance testing described is direct product performance in biological models, not an assessment requiring adjudication of human interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is typically relevant for diagnostic imaging AI systems where AI-assisted human performance is compared to human-only performance. The given device is a bone void filler, and its performance is assessed directly through in vivo models and biocompatibility, not through human interpretation of diagnostic images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described can be considered "standalone" in the sense that they are evaluating the device's intrinsic biological performance directly, independently of human interaction beyond surgical implantation. The "in vivo performance testing" and "biocompatibility testing" assess the material's properties and interaction with biological systems without a human-in-the-loop component for evaluating the device's performance.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be established through the direct outcomes and biological responses observed in the "in vivo performance testing" and "biocompatibility testing." This would include:
- Histological evaluation: To assess new bone formation, integration with host bone, and resorption rates.
- Imaging (e.g., X-ray, micro-CT): To visualize bone fill and structural integrity.
- Biomechanical testing: To evaluate the strength of the repaired bone.
- Clinical observation: In the case of animal models, observation of healing and any adverse reactions.
- Biocompatibility assays: To determine cytotoxicity, sensitization, irritation, etc., as per the specified guidance document.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to the assessment of this device. A bone void filler is a physical implant, not an AI or machine learning model that requires training data. Its performance is evaluated through direct experimental testing.
9. How the Ground Truth for the Training Set Was Established
As established in point 8, a "training set" is not relevant for this 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.