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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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AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

Desertifican of this an odorless, opaque wax-like material designed to be utilized directly AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized.

Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical Osed for over he edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

The provided text is a 510(k) summary for the Ceremed, Inc. AOC Bone Wax. This document focuses on establishing substantial equivalence to predicate devices, primarily through comparison of intended use, materials, and mechanical properties. It does not contain information about acceptance criteria, clinical studies, or performance metrics in a way that would allow for the detailed answers requested in the prompt.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain this information. The submission is a 510(k) for a device that stops bone bleeding by physical occlusion, making it a "physical barrier" device, and therefore the regulatory requirements are different from those for AI/ML-driven diagnostic or prognostic devices that would have the types of performance metrics and studies you're asking about.

Here's what I can infer from the document regarding its regulatory pathway:

• Type of Device: Bone Wax, used for hemostasis (stopping bleeding) from bone surfaces.
• Regulatory Pathway: 510(k) Premarket Notification. This pathway demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy (unless new safety or effectiveness questions are raised).
• Basis for Equivalence: The submission argues for substantial equivalence based on:
  • Same intended use and indications for use as predicate devices.
  • Biocompatibility in accordance with ISO-10993.
  • Substantially equivalent mechanical properties to predicate devices, with "any minor differences raise no new issues of safety and efficacy."
  • The predicate devices were preamendement (Ethicon Bone Wax) or previously cleared 510(k)s (Lukens Bone Wax K791495, Auto Suture Bone Wax K971680).

Why the requested information is not present:

The information requested, such as "table of acceptance criteria and reported device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and "training set details," are typically associated with AI/ML-based diagnostic or prognostic devices that rely on algorithms to interpret data (e.g., images, lab results) and provide a clinical output.

A bone wax, as described, is a physical device with a mechanical function (plugging vascular openings). Its regulatory clearance focuses on material safety, biocompatibility, and physical/mechanical properties that are comparable to existing, safe, and effective devices, not on the performance of a diagnostic algorithm.

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