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510(k) Data Aggregation
(218 days)
Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.
Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.
The provided text describes the 510(k) summary for Zavation Uni-FuZe-C Bone Strip (K221726) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study directly proving the device meets those criteria in a typical AI/software context.
However, based on the information provided, we can infer performance criteria related to the device's biological and physical characteristics and how they were evaluated.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from regulatory requirements and testing) | Reported Device Performance (Summary of results) |
|---|---|---|
| Biocompatibility | Acceptable biological safety profiles (per ISO 10993-1:2018 and FDA Guidance) | Demonstrated acceptable biological safety profiles (Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Systemic reaction, Implantation tests). |
| Material Composition | Meeting specific ASTM standards for constituents | Bioactive glass, collagen, and ß-TCP constituents tested and/or certified to meet ASTM F2212, ASTM F1538, and ASTM F1088 requirements. |
| Biological Performance (In-vivo) | Normal osteoconductive healing response; absence of adverse inflammatory reactions; substantially equivalent performance to predicate. | Macro observations showed healthy tissue absent of adverse inflammatory reactions. Radiographic and microCT analyses indicated no adverse reactions and a normal progression in healing. Histopathology showed normal osteoconductive healing response. Demonstrated substantially equivalent in vivo performance to the primary predicate device across all endpoints. |
| Bioactivity | Precipitation of apatite during in-vitro assessment (per ISO 23317) | Determined to be bioactive per ISO 23317, with bioactive glass granules precipitating apatite in SBF. |
| Packaging Integrity | Meeting acceptance criteria for seal strength and integrity | Packaging seal strength and integrity validated via peel strength (ASTM F88/F88M) and bubble emission (ASTM F2096); acceptance criteria were met. |
| Shipping & Handling | Meeting acceptance criteria for shipping and handling validation | Shipping and handling validations performed per ASTM D7386; acceptance criteria were met. |
| Shelf Life | Validated for the specified duration | Shelf life validated for one-year. |
| Sterilization | Meeting specified SAL and endotoxin levels | Sterilization validated to SAL of 10° using VDmax method per ANSI/AAMI/ISO 11137-2: 2013/(R)2019 with 25 kGy minimum dose. LAL testing showed < 20 EU. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state a numerical sample size for the animal study. It mentions an "established rabbit functional femoral critical cancellous bone defect model." This suggests multiple rabbits were used, but the exact number is not provided.
- Data Provenance: The animal study was a prospective study conducted to compare the subject device (Uni-FuZe-C Bone Strip) with the primary predicate device (MasterGraft Putty). The country of origin for the study is not specified but is likely associated with the manufacturer or a contracted research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts involved in establishing ground truth for the animal study. Clinical judgment from veterinary pathologists or radiologists would typically be involved in interpreting the radiographic, micro-CT, and histological analyses, but this is not explicitly stated.
4. Adjudication method for the test set
The document does not describe an adjudication method for the animal study results. It simply states that "Biological performance was measured using radiographic images, micro-CT, and histological analyses" and that assessments were performed. This implies direct interpretation rather than a consensus-based adjudication process among multiple readers, which is more common in human clinical trials or AI performance evaluations involving subjective assessments.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The study described is an animal model for biological performance, not a human reader study comparing AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical implant (bone strip), not an AI algorithm or software. Therefore, there is no "standalone" algorithm-only performance to assess.
7. The type of ground truth used
For the animal study:
- Direct Observation/Measurement: Macro observations of implant sites.
- Imaging Data: Radiographic images and micro-CT analyses, interpreted for signs of healing and adverse reactions.
- Histopathology: Microscopic examination of tissue samples from the implant sites.
For material properties:
- Standardized Testing Protocols: ASTM standards for material composition (F2212, F1538, F1088) and ISO standards for bioactivity (ISO 23317).
- Laboratory Testing: For packaging, shipping, shelf life, and sterilization.
8. The sample size for the training set
This question is not applicable. The device is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above (no training set for a physical implant device).
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