(11 days)
Orthocon Orthostat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
Orthocon Orthostat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.
When applied manually to surgically incised or traumatically broken bone, Orthostat™ Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.
The provided text is a 510(k) Summary for a medical device called Orthostat™ Hemostatic Bone Putty. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical trials for diagnostic or AI-powered devices.
This submission is a Special 510(k) and focuses on changes to the labeling (adding contraindications) of a device that is otherwise substantially equivalent to its own predicate (meaning, the device itself is unchanged from its prior clearance). Therefore, the provided documentation does not include details about device performance studies that would typically define and measure acceptance criteria in the way described in the prompt.
Given the nature of this submission (a Special 510(k) for labeling changes of a Class I/Unclassified device), the "acceptance criteria" and "study proving the device meets the acceptance criteria" are primarily related to:
- Biocompatibility: Ensuring the material is safe for contact with the body.
- Material properties: Ensuring the putty maintains its physical characteristics and function (hemostatic barrier, absorbability, handling properties).
- Manufacturing controls: Ensuring the device is produced consistently and safely.
- Labeling accuracy: Ensuring contraindications and intended use are clearly stated.
The document states: "This Special 510(k) Notice contains revised Risk Management documents, summaries of biocompatibility testing and reports from investigations of the use of the device. Conformance to applicable Special Controls has been verified. The data presented demonstrate the substantial equivalence of the modified device to the original device." This implies that data exists for these aspects, but the specifics (like acceptance criteria and study results in a table format) are not included in the provided text.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the information provided because:
- No quantitative performance acceptance criteria are mentioned for the device itself. The device's "performance" is its ability to act as a mechanical barrier for hemostasis and its absorbability. These are generally accepted based on previous clearances, material science, and preclinical testing, rather than a clinical study with specific sensitivity/specificity metrics.
- No clinical study demonstrating performance against such criteria is detailed. The document refers to "reports from investigations of the use of the device," but no specifics of these investigations are given (e.g., sample size, type of study, results, comparison to a gold standard).
- The questions about AI, ground truth, experts, and adjudication are not applicable. This device is a physical medical device (hemostatic bone putty), not a diagnostic device or an AI/software as a medical device (SaMD).
In summary, the provided document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and performance study details typical for diagnostic or AI devices.
If this were a typical diagnostic or AI device submission, the required information would be present in a section detailing clinical performance studies.
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