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Syvek Radial™ Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Syvek Radial™ Band is a sterile, single use, disposable device. The Syvek Radial™ Band is a radial artery compression device consisting of a clear medical grade polyurethane compression bladder, which is connected to both the pump and the release valves.

The provided text focuses on the 510(k) summary for the Syvek Radial Band, a vascular clamp. The information is limited to establishing substantial equivalence to a predicate device and does not contain details about a detailed study with acceptance criteria for device performance as typically expected for diagnostic AI/ML devices.

However, based on the provided text, I can infer and structure the information as best as possible within the constraints of the request.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary is for a physical medical device (a vascular compression band), not an AI/ML diagnostic device, and therefore the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device rather than precise diagnostic metrics like sensitivity or specificity.

Acceptance Criteria (Inferred from Substantial Equivalence Claim):
The primary acceptance criterion is substantial equivalence to the predicate device, the Datascope Corp.; Air-Band Radial Compression Device (K122405), in terms of safety and effectiveness. This is demonstrated by:

1. Equivalent Intended Use and Configuration: The device must have the same intended use and similar physical configuration as the predicate.
2. Equivalent Materials: The materials used must be equivalent.
3. Similar Product Design: The overall design should be similar.
4. Similar Operation: Manual operation (inflated/deflated) similar to the predicate.
5. Biocompatibility: Meet ISO 10993 standards for cytotoxicity, sensitization, and irritation/intracutaneous reactivity.
6. Pressure Equivalence: Demonstrate similar pressure performance (peak and hold pressure for extended periods) to the predicate device.

Reported Device Performance (from "Performance Data" and "Summary" sections):

Study Details (as inferable from the provided text):

Since this is a submission for a physical device, not an AI/ML algorithm, many of the requested points are not applicable or the information is not provided.

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

   • Sample Size: Not explicitly stated for any of the performance tests (biocompatibility or pressure equivalence). It only mentions "test articles" for biocompatibility and generic "testing" for pressure equivalence.
   • Data Provenance: The studies were benchtop testing and biocompatibility testing, likely conducted by the manufacturer or contracted labs. Country of origin not specified (Marine Polymer Technologies is based in the US). These tests are inherently "prospective" in the sense that they are conducted specifically for this submission, but not on human patients in a clinical trial.

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

   • Not Applicable. For benchtop and biocompatibility testing of a physical device, "ground truth" is established by adherence to engineering specifications, recognized standards (like ISO 10993), and direct measurement against a predicate device. This doesn't involve expert human interpretation in the same way as, for example, reading medical images.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of medical data determines ground truth, often with disagreement between reviewers. For mechanical and biocompatibility testing, outcomes are typically definitive measurements or pass/fail criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not applicable to a physical compression band like the Syvek Radial Band. Therefore, there's no effect size reported.

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

   • Not Applicable. The Syvek Radial Band is a physical device, not an algorithm.

6. The Type of Ground Truth Used:

   • Engineering/Performance Standards & Predicate Device Comparison:
     • For biocompatibility: ISO 10993 standards and their defined pass/fail criteria.
     • For pressure equivalence: Direct comparative measurements against the predicate device's measured pressure performance.

7. The Sample Size for the Training Set:

   • Not Applicable. As a physical device, there is no "training set" in the context of machine learning.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. No training set exists for this device.

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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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Talymed™ 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, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations Traumatic wounds healing by secondary intention Chronic vascular ulcers Dehisced surgical wounds.

Talymed" is a sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae.

This document is a 510(k) summary for Talymed™, a hydrophilic wound dressing. It is important to note that a 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study in the way a novel AI algorithm might. Therefore, the information provided will reflect this regulatory context.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" and "device performance" are typically framed around demonstrating equivalence to a predicate device. The primary "performance characteristic" is its intended use and physical properties being comparable and safe.

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

The document does not specify a test set sample size or data provenance in the way one would for a clinical trial validating a novel AI device. The 510(k) process relies on:

• Comparison to predicate devices: The "test set" here is primarily the characteristics of the new device and how they compare to legally marketed predicate devices (Marine Polymer Technologies, Taliderm K070557 and Cook Biotech Int. Oasis Wound Matrix K061711).
• Scientific testing: The summary states "Results of scientific testing have ensured that all materials are biocompatible... and physical properties are appropriate." This refers to laboratory-based tests (e.g., cytotoxicity, irritation, sensitization for biocompatibility; tensile strength, absorbency for physical properties) rather than a clinical "test set" on patients. The sample sizes for these lab tests would be determined by relevant ISO standards or internal protocols, but are not disclosed in this summary.
• Data Provenance: Not applicable in the context of clinical data for a "test set" as described. The "data" are results from laboratory tests and a comparison of the device's design and intended use to existing devices.

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

Not applicable. This is not a study involving expert annotation to establish ground truth for a diagnostic AI. The "ground truth" for a 510(k) for a wound dressing is:

• The known safety and performance of the predicate devices.
• The established scientific principles for biocompatibility and material properties.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the context of a 510(k) for physical device characteristics. The assessment is a regulatory review comparing the device to predicates and relevant standards.

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. This is a wound dressing, not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader assistance, or AI component is involved.

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

Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this 510(k) context consists of:

• Predicate Device Performance: The established safety and effectiveness profile of the predicate devices (Taliderm K070557 and Oasis Wound Matrix K061711) for their specified indications.
• Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological safety of medical devices.
• Material Science Principles: General scientific understanding and established test methods for evaluating the physical and chemical properties of materials used in medical devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable. No training set is involved.

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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 < Y%") or provide the actual numerical results against such criteria.

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

The document mentions "Clinical evidence further supported the safety and performance of TALIDERM™" but does not specify the sample size for any clinical or test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth. It refers to "clinical evidence," but the specifics of how that evidence was generated, reviewed, or validated by experts are absent.

4. Adjudication Method:

Since there's no mention of experts or a formal review of test set data, there is no information on adjudication methods such as 2+1 or 3+1.

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

A MRMC study involves multiple human readers evaluating cases, often with and without AI assistance, to measure the impact of the AI. This document pertains to a wound dressing, not an AI/diagnostic device. Therefore, it is highly unlikely and not mentioned that an MRMC comparative effectiveness study was done for TALIDERM™.

6. Standalone Performance Study (Algorithm Only):

TALIDERM™ is a physical wound dressing, not an algorithm or software. Therefore, the concept of a "standalone algorithm only performance" study is not applicable to this device.

7. Type of Ground Truth Used:

The document vaguely refers to "Clinical evidence" and "Animal testing." For a wound dressing, the ground truth for safety and performance would typically involve clinical outcomes data (e.g., wound healing rates, infection rates, adverse events) and observed effects in animal models. However, the specific methodology for establishing this ground truth is not detailed.

8. Sample Size for the Training Set:

Since this is a physical wound dressing and not an AI/machine learning device, the concept of a "training set" in the context of statistical model development is not applicable. The document does not provide sample sizes for any studies that would be analogous to a training set.

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

Again, as this is not an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable.

Summary of what can be extracted and what is missing:

This 510(k) summary explains that TALIDERM™ is a sterile primary wound dressing. The claim for substantial equivalence is based on "indication for use, biocompatibility and performance characteristics."

• Acceptance Criteria & Performance: Not explicitly stated with quantitative metrics. General statements indicate biocompatibility, appropriate physical properties, and safety/performance supported by non-clinical (animal) and clinical evidence, with "no new adverse effects" and "no adverse effects noted" in animal testing.
• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided.
• Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not applicable/mentioned.
• MRMC Study: Not applicable/mentioned.
• Standalone Performance Study: Not applicable/mentioned.
• Type of Ground Truth: Implied to be clinical outcomes and animal model observations, but not detailed.
• Sample Size (Training Set): Not applicable/mentioned.
• Ground Truth Establishment (Training Set): Not applicable/mentioned.

In conclusion, this 510(k) summary is a regulatory document affirming substantial equivalence based on a high-level review of various tests. It does not contain the detailed study information (specific acceptance criteria, sample sizes, expert involvement, or ground truth methodologies) one would expect from a clinical trial report or a submission for an AI-powered device.

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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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