(19 days)
The Orthocon HemaSorb™ Resorbable 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 HemaSorb™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable material of putty-like consistency intended for use it the management of bleeding from the cut surface of bone. The material is a mxture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling mroperties) and alkylene oxide copolymers (a dispersing agent). The material is virtualling proponicos, offwhite 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, HemaSorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and resorbed within a period of 60 days.
The provided document is a 510(k) summary for the Orthocon HemaSorb Resorbable Hemostatic Bone Putty. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI device.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document, as it describes a medical device (hemostatic bone putty) and not a diagnostic algorithm or AI.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance Study for Orthocon HemaSorb Resorbable Hemostatic Bone Putty
The provided 510(k) summary for the Orthocon HemaSorb Resorbable Hemostatic Bone Putty does not detail specific quantitative acceptance criteria or a dedicated performance study with a test set, expert readers, or AI components. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.
The "acceptance criteria" in this context are primarily related to the successful demonstration of substantial equivalence, which involves comparing the new device's intended use, technological characteristics, and performance data (if any) to those of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Substantial Equivalence Review) | Reported Device Performance / Justification |
|---|---|---|
| Intended Use | Must be the same as or very similar to the predicate device. | Identical: "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." (Same as predicate, Orthocon OrthoStat). |
| Technological Characteristics | Materials, composition, mechanism of action, performance attributes (e.g., resorbability, handling properties) must be substantially equivalent. | Similar: Composed of calcium stearate, Vitamin E Acetate, and alkylene oxide copolymers. Mechanism: acts as a mechanical barrier (tamponade) to achieve local control of bleeding. "Virtually non-pyrogenic, 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." Resorbs within 60 days. The submission states it "contains summaries of studies conducted to demonstrate substantial equivalence and a description of the modification made to the composition." |
| Safety and Effectiveness | Device must be as safe and effective as the predicate device. | The 510(k) summary concludes: "The data presented demonstrate that the device is suitable for its indicated use." And "The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: This submission is for a medical device (hemostatic bone putty) and does not involve a "test set" of data or images in the context of an AI/diagnostic device. The "studies" mentioned refer to those demonstrating substantial equivalence, likely bench testing, material characterization, and potentially animal or historical data, rather than a clinical reader study.
- Data Provenance: Not specified, but generally, substantial equivalence relies on physicochemical testing, biocompatibility data, and comparison to the predicate device's established performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: There is no mention of experts establishing "ground truth" in the context of diagnostic interpretation for this type of device.
4. Adjudication Method for the Test Set
- Not Applicable: No test set or expert adjudication related to diagnostic performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: This type of study is not relevant for a hemostatic bone putty and was not conducted or reported in this summary.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is not an algorithm or AI.
7. The Type of Ground Truth Used
- Not Applicable: The concept of "ground truth" in the context of pathology or outcomes data for a diagnostic algorithm is not relevant here. The "truth" for this device relates to its material properties, biocompatibility, and ability to stop bone bleeding, which would be assessed through standard materials science, in vitro, and potentially in vivo (animal or historical human use) testing.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: No training set exists for this device.
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