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510(k) Data Aggregation
(141 days)
HEMASORB APPLY
Hemasorb Resorbable Hemostatic Bone Putty Applicator 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
The Hemasorb Resorbable Hemostatic Bone Putty Applicator (Hemasorb® apply) is a syringe-type applicator containing Hemasorb Resorbable Hemostatic Bone Putty. Use of the applicator will allow convenient discharge of the putty into the surgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is beveled and made from a softer material than the applicator barrel to assist with spreading the material onto the bone.
Hemasorb Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from bone surfaces by acting as a mechanical barrier or tamponade. The putty is a mixture of calcium stearate, Vitamin E acetate, and a liquid surfactant. 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 provided text describes a 510(k) premarket notification for the Hemasorb Resorbable Hemostatic Bone Putty Applicator, focusing on its substantial equivalence to predicate devices rather than a study demonstrating its meeting of specific acceptance criteria through clinical performance metrics against a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment for a standalone algorithm performance study are not available in the provided document. The submission is based on demonstrating substantial equivalence through non-clinical testing.
Here's a breakdown of what can be extracted and what is not available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this submission. The submission is primarily focused on demonstrating "substantial equivalence" to predicate devices, meaning its performance characteristics are similar and equivalent to already-cleared devices, rather than meeting novel performance acceptance criteria for a new clinical claim. The "acceptance criteria" here relate to the successful demonstration of this equivalence for specific characteristics.
| Acceptance Criteria Category | Reported Device Performance (Hemasorb Applicator) |
|---|---|
| Intended Use | Substantially equivalent to predicate devices. |
| Technological Characteristics | Substantially equivalent to predicate devices. |
| Performance | Substantially equivalent to predicate devices. In vitro testing demonstrated this. |
| Specific Performance Tests (Non-Clinical) | (Performed to demonstrate substantial equivalence) |
| Biocompatibility | Demonstrated to be safe and substantially equivalent to the predicate device. |
| - Cytotoxicity | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - Irritation (Intracutaneous Injection) | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - Acute Systemic Injection | Passed (Implicitly, as part of biocompatibility demonstrating substantial equivalence). |
| - HPLC Analysis of putty in contact with the dyed plunger | Performed (Implicitly, to ensure no interaction affecting safety/performance and demonstrate substantial equivalence). |
| - Evaluation of Ignition Potential | Performed (Implicitly, to demonstrate safety and substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on in vitro testing to demonstrate substantial equivalence, not a clinical test set with human data. The testing mentioned (cytotoxicity, irritation, etc.) would use laboratory samples, cell cultures, or animal models, but specific "sample sizes" in the context of human data or a defined "test set" as typically understood for AI/algorithm performance studies are not relevant here. Data provenance is therefore also not applicable in the requested sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "ground truth" to establish in the context of an algorithm's performance on a test set, as this was a 510(k) submission for a physical medical device (bone putty applicator) based on substantial equivalence through in vitro testing.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with adjudicated ground truth was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a 510(k) submission for a medical device (bone putty applicator) focusing on substantial equivalence through in vitro testing, not an AI or imaging algorithm. Therefore, no MRMC study looking at human reader improvement with or without AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical applicator for bone putty, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the requested context. The "ground truth" for this submission was established by comparing the physical and chemical characteristics and performance in in vitro tests against the known characteristics and performance of the predicate devices. The "truth" to be established was whether the new device was "substantially equivalent" to existing, legally marketed devices, not clinical outcomes or expert labels on medical images.
8. The Sample Size for the Training Set
Not applicable. There was 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 was used.
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