(71 days)
Hemasorb Resorbable Hemostatic Bone Putty is intended 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, absorbable material of putty-like consistency intended for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material is a mixture of calcium stearate, vitamin E acetate and a liquid surfactant. The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Hemasorb requires no kneading prior to application and does not soften appreciably at body temperature. The subject of this 510(k) is the addition of a spatula as an alternative method of Hemasorb application.
The provided text describes a 510(k) premarket notification for a medical device called Hemasorb® Resorbable Hemostatic Bone Putty. The submission is for a modification to an already cleared device, specifically the addition of a spatula for application.
Based on the information provided, the "study" conducted is a non-clinical performance testing to demonstrate the substantial equivalence of the modified device (with the spatula) to previously cleared predicate devices.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Integrity & Performance | Ability to maintain integrity under simulated use and shipping conditions, and to function as intended. | "The device was determined to... demonstrate adequate integrity and performance characteristics." |
| Resistance to cyclic compression and tensile failure (for the spatula/device as a system). | Specific thresholds not given, but results confirmed "adequate integrity and performance characteristics." | |
| Overall stability (including sterile package integrity) | "stability (including sterile package integrity)" was tested and deemed adequate. | |
| Biocompatibility | Absence of adverse biological reactions (implied for the material itself). | "The device was determined to be biocompatible." |
| Mechanical Properties | Mechanical performance relevant to handling and application (e.g., tensile failure, cyclic compression). | Test results (though not quantitatively detailed) indicated adequate performance. |
| Material Properties | Consistency, odor, color, spreadability, adhesion to gloves, softening at body temperature. | Described as "soft, moldable," "virtually odorless, off-white," "spread easily with minimal adhesion to surgical gloves," and "does not soften appreciably at body temperature." (This is a description of the device, not necessarily a performance outcome of the study, but it speaks to its inherent characteristics). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a numerical sample size for the non-clinical tests. It refers to "simulated use and shipping" and "mechanical tests," implying a methodology but not concrete numbers of units tested.
- Data Provenance: The study is described as "in vitro tests." No information is provided regarding country of origin of data, nor whether it's retrospective or prospective, as it's a non-clinical, laboratory-based evaluation of a product, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" for non-clinical performance testing typically refers to engineering standards, validated test methods, and pre-defined specifications rather than expert human interpretation of results. The determination of "adequate integrity and performance characteristics" would have been made by the manufacturer's R&D and Quality teams against these internal specifications. No external experts are mentioned for establishing ground truth.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among readers on a diagnosis or finding. This was a non-clinical, objective performance test.
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
This question is not applicable. This submission is for a medical device (bone putty and a spatula), not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC comparative effectiveness study was performed, and there is no AI component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of non-clinical performance testing is based on pre-defined engineering specifications, validated test methods, and industry standards for material performance, integrity, and biocompatibility. The goal was to show that the modified device (with spatula) met these performance characteristics and was equivalent to the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. As there is no training set, this information is not relevant.
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