(269 days)
OrthoBlast® II is an osteoinductive and osteoconductive bone filling material indicated: OrthoBlast® II is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OrthoBlast" II is included to be packed gently mo bony gapo in the exercial see defects may be surgically created or from the result of traumatic injury to the bone.
OrthoBlast® II is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous bone from the same donor, and formulated to a gel or putty-like consistency.
Here's a breakdown of the acceptance criteria and the study information for the IsoTis OrthoBiologics OrthoBlast® II device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define quantitative "acceptance criteria" in the typical sense (e.g., minimum sensitivity, specificity, or specific numerical outcomes). Instead, it describes performance deemed sufficient for substantial equivalence. The "reported device performance" refers to the outcomes of the tests conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Viral Inactivation | Suitable inactivation potential of processing methods for a wide range of potential human viruses. |
| Osteoinductive Potential | The in vitro assay (measuring alkaline phosphatase activity) has been validated against the in vivo athymic rat model. It predicts with at least 95% confidence the in vivo osteoinductivity of the test material. 67 out of 67 test lots that passed the in vitro assay passed the in vivo athymic rat assay (intramuscular bone formation confirmed). |
| Overall Safety & Effectiveness | Data from sheep and rabbit models by histological methods substantiate OrthoBlast II Putty and Paste safety and effectiveness for specified indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Viral Inactivation Validation: Not specified. A "selected panel of viruses" was used. The study type is not explicitly stated as retrospective or prospective, but it's a validation study of the processing methods.
- Osteoinductive Potential:
- In vitro assay: Not specified regarding the number of samples for the in vitro assay validation itself.
- In vivo validation (athymic rat model): 67 individual test lots of DBM.
- Data Provenance: Not specified, but likely from laboratory studies.
- Product Performance Testing (Animal Models): Not specified (e.g., number of animals). "Performance of OrthoBlast II DBM has been evaluated in sheep and rabbit models." The study type is likely prospective animal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Viral Inactivation: Not applicable. Ground truth is determined by lab tests measuring viral inactivation.
- Osteoinductive Potential: Not applicable to human experts. The ground truth for the in vivo validation was "confirmation of intramuscular bone formation" in the athymic rat model, likely assessed by histopathology, which would involve trained histologists, but the number and qualifications are not specified.
- Product Performance Testing (Animal Models): Not applicable to human experts in the context of establishing ground truth for the device's performance directly. The performance was evaluated by "histological methods," which would involve trained histologists, but their number and qualifications are not specified.
4. Adjudication Method for the Test Set
Not applicable to the studies described. The studies are laboratory and animal-based, measured against objective endpoints (viral inactivation metrics, alkaline phosphatase activity, confirmation of bone formation via histology), rather than human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study involving human readers is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a conceptual sense. The studies described (viral inactivation, in vitro and in vivo osteoinductivity, animal performance) assess the device's inherent biological and physical properties and performance characteristics in isolation, without human-in-the-loop interaction as would be relevant for diagnostic AI.
7. The Type of Ground Truth Used
- Viral Inactivation: Laboratory measurements of viral reduction/inactivation.
- Osteoinductive Potential:
- For the in vitro assay: Alkaline phosphatase activity levels compared to controls.
- For the in vivo validation: Histological confirmation of intramuscular bone formation in athymic rats.
- Product Performance Testing (Animal Models): Histological assessment of bone healing/ingrowth in sheep and rabbit models.
8. The Sample Size for the Training Set
- Viral Inactivation Validation: Not applicable, as this is a validation of processing methods, not a "training set" for an algorithm.
- Osteoinductive Potential: Not applicable. While the in vitro assay was "validated against" the in vivo model, it's not a machine learning training set. The 67 test lots mentioned are for validating the in vitro assay's correlation with in vivo results, rather than training an algorithm.
- Product Performance Testing (Animal Models): Not applicable. These are performance studies, not training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning "training set" is described for this device. The studies are evaluating the biological and material properties of the bone void filler.
§ 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.