(352 days)
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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Orthocon 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 the cut surface of bone. The material is a mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. 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, Hemasorb Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty has been shown in animals to be dispersed and substantially absorbed within a period of 30 days.
The provided text describes a 510(k) premarket notification for a medical device called "Hemasorb Resorbable Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing specific acceptance criteria and detailed study results as one might find for a novel device undergoing clinical trials with defined endpoints.
Therefore, for many of the requested categories, the information is not explicitly provided in the document. However, I can extract the relevant information that is present.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance was based on demonstrating "substantial equivalence" to predicate devices. This implies that the performance accepted was that which is comparable to already marketed devices for the same intended use.
- Reported Device Performance:
- Mechanism of Action: Achieves local control of bleeding by acting as a mechanical barrier (tamponade) when applied manually to surgically incised or traumatically broken bone.
- Absorption in Animals: Shown in animals to be dispersed and substantially absorbed within a period of 30 days.
| Feature | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Indicated Use | Comparable to predicate devices: control of bleeding from cut/damaged bone (mechanical barrier/tamponade); use during surgical procedures and traumatic injuries; control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy. | 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy. |
| Mechanical Bleeding Control | Effective as a mechanical barrier/tamponade (comparable to predicate devices). | Achieves local control of bleeding by acting as a mechanical barrier (tamponade). |
| Resorbability (in vivo) | Resorbable within a clinically acceptable timeframe (comparable to predicate devices). | Shown in animals to be dispersed and substantially absorbed within a period of 30 days. |
| Biocompatibility | Biocompatible (implicit for a resorbable implantable material). | Described as "biocompatible." |
| Physical Characteristics (user experience) | Soft, moldable, putty-like consistency; virtually odorless, off-white; spreadable with minimal adhesion to surgical gloves; no kneading; does not soften appreciably at body temperature (comparable to predicate devices). | Sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency. Mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. Virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. Requires no kneading prior to application and does not soften appreciably at body temperature. |
| Sterilization | Compatible with established sterilization methods (comparable to predicate devices). | Stated to be "sterile" and "substantially equivalent ... in sterilization" to predicate devices. |
| Materials | Safe and effective materials (comparable to predicate devices). | Mixture of calcium stearate, Vitamin E acetate, and liquid surfactant. Stated to be "substantially equivalent ... in materials" to predicate devices. |
| Overall Performance | Substantial equivalence to predicate devices (K043260, K091121, K102762, K102071). | Hemasorb was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and performance. Pre-clinical testing included animal testing in a sternotomy model. Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091121, K102762, and K102071) in indications, intended use, design, materials, sterilization, and performance. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "animal testing in a sternotomy model" as part of pre-clinical testing but does not provide the number of animals or specific details of the study design or sample size.
- Data Provenance: The study was pre-clinical, involving animal testing. No country of origin is specified for the study data. It is inherently prospective from the perspective of the animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This type of submission relies on pre-clinical data (animal studies) and comparison to predicate devices, not human expert consensus for a diagnostic AI. The "ground truth" for the animal study would be the observable control of bleeding and subsequent absorption.
4. Adjudication method for the test set
- Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical endpoints that require review, typically in diagnostic imaging or clinical trials. The animal study would have direct physiological outcomes.
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
- Not applicable. This is a medical device for hemostasis, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device for hemostasis. The "performance" is inherent to the material properties and how it interacts with bone to stop bleeding, not an algorithm.
7. The type of ground truth used
- For the animal study: Physiological outcomes related to hemostasis (control of bleeding) and material absorption (e.g., visual assessment, histological analysis) would serve as the ground truth.
- For the substantial equivalence claim: The "ground truth" is established by comparing the device's characteristics (indications, intended use, design, materials, sterilization, performance) against those of the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set. The "development" would involve material science, formulation, and in vitro/in vivo testing, not algorithm training.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/ML device.
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