(218 days)
Osteo3 ZP Putty is indicated for filling bone voids or defects of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or as a result of traumatic injury to the bone. Osteo3 ZP Putty is a bone graft putty that is resorbed and replaced with bone during the healing process. Osteo3 ZP Putty must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine.
Osteo3 ZP Putty is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. Osteo ZP Putty contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished Osteo2 ZP Putty is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables Osteo3 ZP Putty to be implanted directly from the packaging without any further gelation, mixing or graft setting time. Osteo3 ZP Putty is provided sterile to the end user in 5 cc and 10 cc sizes.
The provided FDA 510(k) summary for Osteo3 ZP Putty describes a medical device, not an AI/ML-driven diagnostic tool. Therefore, many of the requested categories related to AI/ML performance, ground truth, experts, and reader studies are not applicable.
However, I can extract and present the information available regarding the device's performance and the studies conducted to demonstrate its "substantial equivalence" to predicate devices, which serves as its acceptance criteria in the regulatory context.
Acceptance Criteria and Device Performance for Osteo3 ZP Putty
The acceptance criteria for Osteo3 ZP Putty are based on demonstrating "substantial equivalence" to legally marketed predicate devices through non-clinical and animal testing. This means the device must perform comparably to established devices when evaluated using relevant endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Demonstrated Equivalence To) | Reported Device Performance |
|---|---|---|
| Material Properties | Predicate Device: K140375 MASTERGRAFT® Strip; MASTERGRAFT® Putty | |
| - Chemical Composition (silicated calcium phosphate vs. β-tricalcium phosphate and hydroxyapatite) | ||
| - Physical Properties (granule size, porosity to support bone ingrowth) | ||
| - Biocompatibility | ||
| Predicate Device: K071206 Actifuse™ ABX E-Z-fil Bone Graft Substitute | ||
| - Chemical Composition (silicated calcium phosphate) | ||
| - Physical Properties (granule size, porosity) | ||
| - Biocompatibility | ||
| Reference Device: K173525 NovoGro | ||
| - Chemical Composition (silicon content in mineral component) | The subject device, Osteo3 ZP Putty, is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler with 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. | |
| Non-clinical testing (chemical composition, physical properties, sterilization, material-mediated pyrogenicity, bacterial endotoxin, sterile barrier shelf life, product shelf life, and biocompatibility) was performed and relied upon to demonstrate substantial equivalence. | ||
| The silicon content (5.8% by weight) is within the range of the additional predicate K071206 (0.8% by weight) and the reference device K173525 (14% by weight). | ||
| Granule size (1-2 mm) and porosity (>75%) are comparable to predicate devices. | ||
| Performance in Posterolateral Spine Model | Predicate Device: K140375 MASTERGRAFT® Strip; MASTERGRAFT® Putty | |
| - Equivalence in manual palpation results for fusion. | ||
| - Equivalence in range of motion/flexibility testing. | ||
| - Equivalence in plain and high-resolution radiography findings. | ||
| - Equivalence in micro-CT imaging metrics (e.g., bone volume, implant integration). | ||
| - Equivalence in undecalcified histologic evaluation (new bone formation, implant resorption). | ||
| - Equivalence in histomorphometric analysis. | ||
| - Equivalence in Decalcified paraffin histology grading according to ISO 10993-6 (Annex E). | In a rabbit posterolateral spine fusion model, the performance of Osteo3 ZP Putty was demonstrated to be equivalent to that of the primary predicate device K140375 based on radiographic, histologic, and histomorphometric evaluations at 6, 9, and 12 weeks. | |
| Performance in Critical-Sized Defect Model | Predicate Device: K071206 Actifuse™ ABX E-Z-fil Bone Graft Substitute | |
| - Equivalence in plain and high-resolution radiography findings. | ||
| - Equivalence in micro-CT imaging metrics. | ||
| - Equivalence in undecalcified histologic evaluation. | ||
| - Equivalence in histomorphometric analysis. | ||
| - Equivalence in Decalcified paraffin histology grading according to ISO 10993-6 (Annex E). | In a rabbit critical-sized defect model, the performance of Osteo3 ZP Putty was demonstrated to be equivalent to that of the additional predicate device K071206 based on radiographic, histologic, and histomorphometric evaluations at 4 and 12 weeks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Rabbit Posterolateral Spine Fusion Model: Not explicitly stated in the provided text, but implied to be a sufficient number of rabbits to conduct the various evaluations (manual palpation, range of motion, radiography, micro-CT, histology, histomorphometry) for the subject device, primary predicate, and autograft (positive control) at multiple time points (6, 9, 12 weeks).
- Rabbit Critical-Sized Defect Model: Not explicitly stated in the provided text, but implied to be a sufficient number of rabbits for the subject device, additional predicate, and unfilled control (negative control) at multiple time points (4, 12 weeks).
- Data Provenance: The studies were prospective animal studies conducted in rabbits. The country of origin for the animal studies is not specified in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies were animal models evaluating biological and physical outcomes, not human diagnostic interpretations. Ground truth was established through objective measurements and histological assessments by trained personnel.
4. Adjudication Method for the Test Set
This information is not applicable as the studies were animal models evaluating biological and physical outcomes, not human diagnostic interpretations requiring adjudication among experts. Objective measurements and analyses (e.g., micro-CT, histomorphometry, ISO grading) were used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relied on non-clinical and animal performance testing, not human reader studies.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop) Was Done
This information is not applicable as the device is a bone void filler, not an algorithm or AI system. Its performance is intrinsic to its material properties and biological interaction in vivo.
7. The Type of Ground Truth Used
The ground truth for the animal studies was established through a combination of objective biological and imaging assessments:
- Manual palpation: To assess fusion solidity in the spine model.
- Range of motion/flexibility testing: To quantify fusion success.
- Plain and high-resolution radiography: Imaging evidence of bone regeneration.
- Micro-computed tomography (micro-CT) imaging: Detailed 3D quantitative analysis of bone formation and implant resorption.
- Undecalcified histologic evaluation: Microscopic assessment of tissue response, new bone formation, and material integration/resorption.
- Histomorphometric analysis: Quantitative histological measurements (e.g., percentage of bone, soft tissue, remaining implant).
- Decalcified paraffin histology sections graded according to ISO 10993-6 (Annex E): Standardized biocompatibility and tissue response assessment.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical implant, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (not an AI/ML algorithm).
§ 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.