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MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for 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. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided text describes the Montagne Settable, Resorbable Hemostatic Bone Putty. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, success rate within a defined timeframe). Instead, it states more general performance outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size for this clinical evaluation, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set of the clinical evaluation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention or describe a MRMC comparative effectiveness study, nor does it discuss human improvement with or without AI assistance. This is expected as the device is a medical device (putty), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document does not describe a standalone performance study in the context of an algorithm. This is not applicable to a physical medical device like bone putty.

7. Type of Ground Truth Used:

For the "human clinical evaluation" mentioned, the ground truth would implicitly be clinical outcomes (e.g., successful hemostasis, absence of re-bleeding, safety events) as observed and documented by the operating surgeons and medical staff. However, the document does not explicitly state the specific ground truth used. For other performance tests (biocompatibility, sterility, etc.), the ground truth would be established through standardized testing protocols and laboratory measurements as per ISO 10993 and other relevant standards.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a physical medical device (bone putty) undergoing a 510(k) submission, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance is typically established through a combination of bench testing, animal studies (if applicable), and clinical evaluation.

9. How the Ground Truth for the Training Set Was Established:

Since there is no "training set" in the context of an algorithm, this question is not applicable. The performance characteristics for the device were likely established through the aforementioned laboratory tests and clinical evaluation, with ground truth based on observed biological or physical responses to the device.

In summary, the provided document is a 510(k) summary focused on substantial equivalence for a medical device. It briefly mentions performance testing and a clinical evaluation but lacks specific details typically found in summaries for AI/ML-powered devices, such as sample sizes, expert qualifications, or detailed performance metrics. The main purpose of this 510(k) was to add a new indication for use (sternotomy procedures) based on demonstrated equivalence to the previously cleared version of the same device and a predicate device.

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Orthocon HEMASORBpress 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. HEMASORBpress Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, resorbable 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 an 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, 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 30 days.

The provided text is a 510(k) summary for the Orthocon HEMASORBpress™ Resorbable Hemostatic Bone Putty. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device and does not describe a study involving an AI algorithm or its performance against acceptance criteria for an AI-driven task like image analysis.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document details physical and biological testing conducted on the HEMASORBpress device and its predicate. Here's a summary of the device-specific testing mentioned, as it relates to demonstrating safety and effectiveness for a physical medical device, not an AI:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of quantitative acceptance criteria with corresponding reported device performance values in the format usually seen for AI or diagnostic devices. Instead, it lists the types of tests conducted to ensure the device's properties and safety/effectiveness are comparable to predicate devices. The implicit "acceptance criteria" here are that the device performs satisfactorily and similarly to predicate devices in these tests.

• Handling Properties (Strip Configuration): Usability testing performed to verify handling. (Implicit: Satisfactory handling for the new configuration.)
• Dissolution & Swelling Properties (Original Device): Evaluated. (Implicit: Acceptable dissolution and swelling profile.)
• Product Interface with Mesh (Strip Configuration): Tested. (Implicit: Satisfactory interaction between bone putty and polypropylene mesh.) |
  | Biocompatibility: | * ISO 10993 Compliance (Original Device): Cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation/subacute toxicity, hemolysis, and pyrogenicity studies conducted on final, finished, gamma-irradiation sterilized device, in accordance with GLP requirements. (Implicit: Biocompatible, passes all specified tests per ISO 10993.)
• Cytotoxicity (Strip Configuration): Cytotoxicity testing of the polypropylene mesh performed. (Implicit: Polypropylene mesh is biocompatible.)
• Pyrogen Testing (Strip Configuration): USP and rabbit pyrogen testing performed. (Implicit: Non-pyrogenic.) |
  | In Vivo Performance: | * Animal Studies (Original Device): Demonstrated intraoperative in vivo hemostasis, resistance to irrigation, ability to remove the device, and characterized safety and absorption time. (Implicit: Device effectively controls bleeding, is resistant to irrigation, removable, safe, and absorbs within an acceptable timeframe in vivo.) |
  | Packaging Stability: | * Package Stability Testing (Strip Configuration): Performed. (Implicit: Packaging maintains device integrity and sterility over time.) |

2. Sample size used for the test set and the data provenance:

• No information provided regarding sample sizes for individual tests. The document only "Testing was conducted" or "Testing included animal studies."
• Data Provenance: Not explicitly stated for each test, but generally, these are laboratory bench tests and animal studies conducted by or for the manufacturer (Orthocon, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as the document describes a physical medical device, not an AI algorithm requiring expert ground truth for diagnostic or interpretative tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for the type of device testing described.

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 as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the physical properties and biocompatibility, the "ground truth" is based on standardized test methods and validated measurements against defined parameters (e.g., ISO standards for biocompatibility, specific physical property measurements).
• For in vivo performance, the "ground truth" is derived from direct observation and measurement in animal models (e.g., cessation of bleeding, absorption time).

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established:

• Not applicable.

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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.

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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