(113 days)
OssiMend, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
OssiMend™ Bone Graft Material (OssiMend) is a collagen mineral composite matrix processed into strips, pads, or granular form for surgical implantation. The principle components of OssiMend are bovine type I collagen and anorganic bovine bone mieral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. OssiMend is provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. OssiMend strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. OssiMend is fully resorbed during the natural process of bone formation and remodeling.
This a 510(k) premarket notification for a medical device called OssiMend™ Bone Graft Material. Generally, 510(k)s do not contain detailed study reports as a PMA (Pre-Market Approval) submission would. Instead, they demonstrate substantial equivalence to a predicate device.
Based on the provided text, here's a breakdown of the acceptance criteria and the study information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for OssiMend in the way one might expect for a diagnostic or imaging device. Instead, the "Effectiveness" section states:
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Effectiveness | Meet design requirements for an effective bone grafting material | Confirmed effectiveness for use as a bone void filler |
| Safety/Biocompatibility | Pass specified biological evaluation tests | Passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing |
The "Conclusion" summarizes that the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and an animal study show that OssiMend Bone Graft Material is safe and substantially equivalent to its predicates. This implies the acceptance criteria were met by demonstrating substantial equivalence in these aspects.
2. Sample sized used for the test set and the data provenance
The document mentions "an animal study" but does not provide details on the sample size for this study or the specific animals used.
Data provenance: The study was an "animal study," indicating non-human data. There is no information regarding the country of origin. The study was likely prospective, as it was conducted to evaluate the device's effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As an animal study for a bone graft material, the "ground truth" would likely be based on histological analysis or imaging assessments by veterinarians or pathologists, rather than expert human interpretation of medical images.
4. Adjudication method for the test set
This information is not provided. Given it's an animal study assessing bone regeneration, it's unlikely to involve adjudication in the typical sense of a human reader study. Assessment would more likely be by objective measures and pathologist reports.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of images, not for a bone graft material. The device itself is a material for implantation, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a bone graft material, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the animal study, the ground truth for effectiveness would likely be based on histopathology, imaging (e.g., radiography, CT scans) to assess bone formation, and possibly biomechanical testing of the regenerated bone. The document states "an animal study confirmed the effectiveness of the product," which implies objective biological measures of bone healing.
8. The sample size for the training set
This information is not applicable. This is a biological material, not an AI algorithm that requires a training set. The "design requirements" and "material characterization" would be based on scientific principles and in vitro testing, not machine learning training.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 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.