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Orthostat Bone Hemostat Matrix 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

This submission is for Orthostat packaged in a syringe type applicator containing 3.5g of Orthostat bone hemostat. This will allow convenient discharge of the purgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is tapered and made from a softer material to assist with spreading the material onto the bone.

This 510(k) submission (K102762) is for a medical device called the "Orthostat Bone Hemostat Matrix Applicator," which is intended for controlling bleeding from bone. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Orthostat Bone Hemostat Matrix," rather than proving clinical effectiveness through a new clinical study. Therefore, much of the information typically associated with studies proving device performance against acceptance criteria for diagnostic AI/software devices is not directly applicable here.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not an AI/software diagnostic device, so typical performance metrics like sensitivity, specificity, or AUC are not relevant. Instead, the "acceptance criteria" are related to safety, biocompatibility, and functional equivalence to the predicate device.

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

The document states that "No clinical tests were performed to determine substantial equivalence." Therefore, there is no clinical test set for performance comparison in the traditional sense for human efficacy.

For the non-clinical tests:

• Handling and Usability: This was evaluated during "animal and human cadaver evaluation." No specific sample sizes for these evaluations are provided.
• Material Safety, Tip Tensile Strength, Biocompatibility: These are typically conducted on material samples or device prototypes, not on a "test set" from a patient population. Sample sizes would be determined by relevant ASTM or ISO standards for mechanical and biocompatibility testing. The data provenance is laboratory testing.

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

Not applicable. As no clinical tests were performed, there was no expert-adjudicated ground truth established for a clinical test set. The non-clinical tests rely on established scientific methods and standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission focuses on a new applicator for an existing device, not a diagnostic AI or imaging analysis tool that would typically involve human readers.

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

Not applicable. This device is a physical applicator, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Predicate Device Equivalence: The primary ground for substantial equivalence is the prior FDA-cleared predicate device (Orthostat Bone Hemostat Matrix, K043260, K091121).
• Non-Clinical Test Results: The "ground truth" for the non-clinical tests (material safety, tip tensile strength, handling, usability, biocompatibility) is determined by the specific pass/fail criteria defined by relevant industry standards and internal specifications, which were met. For biocompatibility, it's typically based on ISO 10993 standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."

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

Not applicable, as there is no training set.

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Orthocon Orthostat™ 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 Orthostat™ 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 (a wax-like tamponade), Vitamin E Acetate (for handling properties) and 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, Orthostat™ Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

The provided text is a 510(k) Summary for a medical device called Orthostat™ Hemostatic Bone Putty. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical trials for diagnostic or AI-powered devices.

This submission is a Special 510(k) and focuses on changes to the labeling (adding contraindications) of a device that is otherwise substantially equivalent to its own predicate (meaning, the device itself is unchanged from its prior clearance). Therefore, the provided documentation does not include details about device performance studies that would typically define and measure acceptance criteria in the way described in the prompt.

Given the nature of this submission (a Special 510(k) for labeling changes of a Class I/Unclassified device), the "acceptance criteria" and "study proving the device meets the acceptance criteria" are primarily related to:

• Biocompatibility: Ensuring the material is safe for contact with the body.
• Material properties: Ensuring the putty maintains its physical characteristics and function (hemostatic barrier, absorbability, handling properties).
• Manufacturing controls: Ensuring the device is produced consistently and safely.
• Labeling accuracy: Ensuring contraindications and intended use are clearly stated.

The document states: "This Special 510(k) Notice contains revised Risk Management documents, summaries of biocompatibility testing and reports from investigations of the use of the device. Conformance to applicable Special Controls has been verified. The data presented demonstrate the substantial equivalence of the modified device to the original device." This implies that data exists for these aspects, but the specifics (like acceptance criteria and study results in a table format) are not included in the provided text.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the information provided because:

• No quantitative performance acceptance criteria are mentioned for the device itself. The device's "performance" is its ability to act as a mechanical barrier for hemostasis and its absorbability. These are generally accepted based on previous clearances, material science, and preclinical testing, rather than a clinical study with specific sensitivity/specificity metrics.
• No clinical study demonstrating performance against such criteria is detailed. The document refers to "reports from investigations of the use of the device," but no specifics of these investigations are given (e.g., sample size, type of study, results, comparison to a gold standard).
• The questions about AI, ground truth, experts, and adjudication are not applicable. This device is a physical medical device (hemostatic bone putty), not a diagnostic device or an AI/software as a medical device (SaMD).

In summary, the provided document does not contain the information required to answer the prompt's specific questions regarding acceptance criteria and performance study details typical for diagnostic or AI devices.

If this were a typical diagnostic or AI device submission, the required information would be present in a section detailing clinical performance studies.

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The Orthocon OrthoStat™ 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 OrthoStat™ 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 (a wax-like tamponade), Vitamin E Acetate (for handling properties) and 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, OrthoStat Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way typically expected for a diagnostic AI/ML device.

The document is a 510(k) summary for a medical device called "OrthoStat™ Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than proving diagnostic performance against specific metrics with a test set, ground truth, or expert review.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Device Type: OrthoStat™ Hemostatic Bone Putty is a hemostatic agent (a physical barrier to stop bleeding), not an AI/ML diagnostic tool or a device that interprets data for diagnosis. Therefore, the concepts of "acceptance criteria for device performance" in terms of accuracy, sensitivity, specificity, etc., or "expert ground truth" as applied to diagnostic image interpretation, do not apply.
• Study Focus: The "studies" mentioned are typically engineering tests, biocompatibility assessments, and functionality/efficacy testing to show the device performs its intended mechanical function (stopping bleeding) and is safe. These are not comparative effectiveness studies with human readers or standalone algorithm performance studies.
• "Acceptance Criteria" in this Context: For a device like bone putty, "acceptance criteria" likely refer to successful outcomes in non-clinical tests (e.g., in vitro or animal models) showing it effectively stops bleeding, is absorbed within a specified timeframe, and is biocompatible. These are not explicitly detailed here with numerical targets as would be for a diagnostic tool.

Therefore, I cannot provide the requested table and information because the document describes a different type of medical device and regulatory submission where those specific performance metrics, study designs, and ground truth methodologies are not applicable or detailed.

The document states:

• "The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results, absorption testing and biocompatibility testing."
• "The data presented demonstrate that the device is biocompatible and is suitable for its indicated use."

This indicates that these tests were performed to support the "suitability for indicated use" and "biocompatibility," which are the operational criteria for this type of device. However, the specifics of these results and their acceptance criteria are not presented in the provided text.

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