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MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries. MP719 is intended for use under the direction of a healthcare professional.

MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding. MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.

The provided document describes the MP 719, a sterile, resorbable, non-woven membrane material for bone hemostasis. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to predicate devices, rather than prove effectiveness through specific acceptance criteria and clinical studies in the same way a PMA (Premarket Approval) would. Therefore, the information provided focuses on comparative testing and biocompatibility rather than defined clinical acceptance metrics and their achievement in randomized controlled trials.

Here's an analysis based on the provided text, addressing the requested points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined thresholds for clinical efficacy that the device must meet (e.g., sensitivity, specificity for a diagnostic device). Instead, it presents results of various tests demonstrating that the device performs similarly to or better than predicate devices and is safe for its intended use. The "Conclusion" column largely serves as the reported "device performance" relative to internal specifications or predicate devices.

2. Sample Sizes and Data Provenance (for test set/studies)

• Animal Studies:
  • Hemostasis produced by MP719 Implanted in Cortical Defects in the Rabbit Femur: The study was conducted in rabbits. The specific number of rabbits or defect sites used is not provided.
  • Implantation Study of MP719 in Femur Cortical Bone of Rabbit: Again, conducted in rabbits. Specific sample size is not stated.
  • Biocompatibility tests (e.g., Cytotoxicity, Sensitization, Irritation, USP Class VI, ISO Implantation, Hemocompatibility, Systemic Toxicity, Genotoxicity): These refer to standard biological evaluation tests. While the species are mentioned (e.g., L929 cells for cytotoxicity, rabbits/mice for various in vivo tests, Salmonella for genotoxicity), specific sample sizes for each test are not detailed in this summary.
• Data Provenance: The animal studies were in vivo experiments. The country of origin for the data is not specified, but typically such studies would be conducted in the country of the submitting company or by contract research organizations (CROs) adhering to international standards. The studies appear to be prospective in their design (i.e., designed specifically to test MP719).

3. Number of Experts and Qualifications (for ground truth)

This type of information is generally not applicable to a 510(k) submission for a device like MP 719. The "assessments" here are primarily objective laboratory and in vivo animal study results, not subjective interpretations requiring expert consensus for a "ground truth" as would be the case for a diagnostic imaging AI, for example. The "conclusion" for animal studies, such as "MP719 and Bone Wax were considered equivalent in their hemostatic performance," would involve assessment by veterinarians or researchers involved in the animal model. Their specific qualifications (e.g., DVM, PhD in toxicology, etc.) are implied by the nature of the studies but not explicitly stated or quantified in terms of "number of experts."

4. Adjudication Method (for test set)

Not applicable. There is no "test set" in the sense of human-interpreted cases requiring adjudication. The studies are empirical laboratory and animal experiments.

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

Not applicable. MRMC studies are typically used for evaluating diagnostic devices (e.g., imaging AI) where human readers interpret cases. This device is a bone hemostasis implant.

6. Standalone Performance

The vast majority of the studies (benchtop, biocompatibility, and the hemostasis/implantation animal studies) assess the MP 719 device itself without human intervention in the "performance" component beyond its application. For example, the biocompatibility tests evaluate the device's material properties and interaction with biological systems in a standalone manner. The animal hemostasis study compares MP719 directly against bone wax, demonstrating its standalone effectiveness in controlling bleeding in that model.

7. Type of Ground Truth Used

• Benchtop Tests: Based on predefined analytical specifications (e.g., IR spectrum matching, quantitative limits for elements or moisture, thresholds for bioburden/endotoxin).
• Biocompatibility Tests: Based on standardized biological assay results (e.g., cell viability, observed skin reactions, mutation rates, systemic toxicity scores, histological findings) according to established international standards (ISO, USP, ASTM).
• Animal Studies (Hemostasis, Implantation): Based on direct observation and measurement of biological effects in animal models (e.g., cessation of bleeding, macroscopic and microscopic assessment of tissue reactions, comparison to control/predicate devices). This is akin to outcomes data within the experimental animal model.

8. Sample Size for the Training Set

Not applicable. MP 719 is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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mRDH Bandage™ is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.

mRDH Bandage " is a soft. white, sterile non-woven lyophilized pad of a cellulosic polymer isolated from microalgae (poly-N-acetylglucosamine). It is attached to x-ray detectable gauze and packaged in a sterile blister pack. mRDH Bandage" is available as a 4in x 4in (10cm x 10cm) bandage.

I am sorry, but this document contains no information about acceptance criteria or the study that proves the device meets those criteria. It is a 510(k) summary and approval letter which focuses on establishing substantial equivalence to a predicate device. Therefore, I cannot extract the requested details.

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TALIDERM™ is intended for use under the direction of a healthcare professional.

TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.

TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.

This document is a 510(k) summary for a medical device called TALIDERM™, a wound dressing. It declares substantial equivalence to predicate devices based on biocompatibility and performance characteristics. However, it does not include detailed acceptance criteria or a study that proves the device meets those criteria, as typically found in clinical trial reports for devices that require them.

Here's an analysis of why the requested information cannot be fully provided based solely on the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria or quantitative performance metrics for TALIDERM™. Instead, it states:

• "Results of scientific testing have ensured that the material is biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
• "Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse effects noted."
• "Clinical evidence further supported the safety and performance of TALIDERM™."

These are general statements affirming that testing was done and the outcomes were positive, but they do not define specific, measurable acceptance criteria (e.g., "wound closure rate > X%", "infection rate

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Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit:

• 1. a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing,
• a disposable Polypropylene support structure, which snaps on to component 3, 2.
• 3. a reusable Plexiglas handle, and
• 4. a Tegaderm® transparent adhesive bandage
     Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.

This document is a 510(k) summary for the Syvekexcel Vascular Access Hemostasis System, seeking substantial equivalence to predicate devices. It describes the device, its intended use, and claims substantial equivalence based on scientific testing. However, it does not contain any information about acceptance criteria or the specifics of a study evaluating the device's performance against such criteria.

Therefore, I cannot fulfill your request for the tables and study details. The provided text primarily focuses on the regulatory submission process and the declaration of substantial equivalence, rather than presenting a performance study against specific acceptance criteria.

To answer your questions, I would need a document that includes performance data, defined acceptance criteria, details about the study design (sample size, ground truth, experts, adjudication), and potentially a comparative effectiveness study. This K053300 submission does not provide that level of detail.

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ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

Not Found

The provided document is an FDA 510(k) clearance letter for two devices: Syvekpatch (prescription) and Prodein (over-the-counter). It does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document primarily focuses on:

• Substantial Equivalence Determination: The FDA determined that the devices are substantially equivalent to devices marketed prior to May 28, 1976.
• Limitations on Labeling: Specific claims the device cannot make (e.g., accelerating wound healing, long-term dressing, treatment/cure).
• Indications for Use:
  • ProDein™ Patch: Local management of bleeding wounds such as lacerations, abrasions, and nosebleeds.
  • SyvekPatch™: Under the direction of a healthcare professional for rapid control of bleeding following hemodialysis, in patients on anticoagulation therapy, and local management of bleeding wounds such as vascular access sites, percutaneous catheters/tubes, and surgical debridement.
• Regulatory Information: General controls provisions, annual registration, GMP compliance, and other federal laws.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document.

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The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

Not Found

The provided text is a clearance letter from the FDA for the Syvek Patch™ (K972914) dated December 22, 1997. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. The letter simply grants market clearance based on substantial equivalence, implying that the detailed studies proving performance against specific criteria would have been part of the 510(k) submission, but those details are not present in the provided content.

Therefore, I cannot provide the requested information.

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