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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 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

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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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

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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