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HemCon ChitoFilex™ Surgical is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatalogical, etc.) and traumatic injuries.

The HemCon ChitoFlex™-Surgical Dressing is a sterile chitosan based dressing intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatalogical, etc.) and traumatic injuries.

I am sorry, but the provided text is a 510(k) premarket notification from the FDA regarding a medical device, the "HemCon ChitoFlex™ -Surgical Dressing". This document confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

1. Acceptance criteria and reported device performance: The document confirms substantial equivalence but does not specify performance metrics or acceptance criteria for the device itself.
2. Study details: There is no mention of any specific study conducted to prove the device meets acceptance criteria, including sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or the type of ground truth used.
3. Training set details: No information about a training set, its sample size, or how its ground truth was established is provided.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document is primarily an FDA clearance letter based on substantial equivalence to existing devices, not a detailed study report.

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The HemCon® Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

The HemCon® Dental Dressing is identical in material, design and composition to the legally marketed HemCon® Bandage (K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). The only differences are the indication for use in the oral cavity and the reduction in size for the use in the oral cavity (10 cm x 10 cm for the legally marketed HemCon® bandage versus 10 mm x 12 mm for the dental dressing). Additionally, the HemCon® Dental Dressing is provided without the non-stick backing used on the HemCon® Bandage.

The HemCon® Dental Dressing is a lyophilized (freeze-dried) chitosan-based dressing designed to optimize the mucoadhesive surface density and structural integrity of chitosan at the wound site. The HemCon® Dental Dressing may be manufactured to any size and is currently available in 10 mm x 12 mm rectangular dressing and is packaged in a vacuum-sealed aluminum pouch and processed with gamma radiation for sterile single-use only application.

This Premarket Notification (510(k)) for the HemCon® Dental Dressing does not contain the detailed study information typically found in a clinical trial report or specific performance testing document. As such, I cannot extract acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details directly from the provided text.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (HemCon® Bandage K023298, cleared 04 November 2002 with update K043050, cleared 03 June 2005). Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. This approach typically relies on demonstrating that the new device has the same intended use, and the same technological characteristics as the predicate device, or if there are differences in technological characteristics, that these differences do not raise different questions of safety and effectiveness, and that the device is as safe and effective as the legally marketed device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document states that the HemCon® Dental Dressing is "identical in material, design and composition" to the legally marketed HemCon® Bandage, except for size and the absence of a non-stick backing. It infers that the performance of the Dental Dressing will be equivalent to the predicate based on this similarity. Specific performance metrics for the Dental Dressing are not presented.

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

• Not provided. There is no mention of a dedicated test set or associated data. The reliance is on the substantial equivalence to the predicate device.

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

• Not applicable. No such study or ground truth establishment is described for the Dental Dressing itself.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• Not applicable. This type of study is not mentioned as it is typically associated with diagnostic devices, not wound dressings like this.

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

• Not applicable. This is a medical device, not an AI algorithm.

7. The type of ground truth used:

• Not applicable for the HemCon® Dental Dressing itself. The "ground truth" for the new device's clearance is its substantial equivalence to the predicate device. The predicate device (HemCon® Bandage) would have had its own original clearance studies, which are not detailed here.

8. The sample size for the training set:

• Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

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

• Not applicable.

Summary of what can be extracted from the document:

• The device: HemCon® Dental Dressing.
• Indication for Use: An oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
• Basis for Acceptance: Substantial equivalence to the legally marketed HemCon® Bandage (K023298, K043050). The new device is "identical in material, design and composition" to the predicate, with only differences in size and the absence of a non-stick backing.
• Regulatory Status: Cleared by the FDA as substantially equivalent on July 7, 2006.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the demonstration of substantial equivalence to a predicate device rather than a new, independent performance study for the HemCon® Dental Dressing. The acceptance criteria were met by proving it was sufficiently similar to an already approved product for its intended use.

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The HemCon® Bandage is intended as an external temporary wound treatment for the control of severely bleeding wounds for emergency use. In addition, the HemCon® Bandage also controls bleeding in patients following hemodialysis. The HemCon® Bandage OTC is intended for the local management of bleeding such as laceration and minor bleeding.

The HemCon® Bandage and the HemCon® Bandage OTC are each applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon® Bandage and the HemCon® Bandage OTC are manufactured from chitosan, a material consisting of cellulosic polymer, poly[ß(1->4)-2-amino-2-deoxy-D-dlucopyranose]. These devices are packaged in a foil package and provided sterile. They are sterilized by gamma irradiation at a dose adequate to ensure a SAL of 10 %.

This document is a 510(k) summary for the HemCon® Bandage and HemCon® Bandage OTC. It refers to previous submissions for performance data and states that the current devices are identical to predicate devices in intended use, material, performance, sterilization method, and method of application. This means a new study specifically for this 510(k) submission was not required as equivalence was based on prior data and minor modifications.

Therefore, many of the requested details about a new study (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new study) are not applicable to this specific 510(k) submission.

However, I can extract information regarding acceptance criteria and reported performance from the provided text, as well as details about the previous studies that established equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

This 510(k) submission states, "Performance data for the HemCon® Bandage and the HemCon® Bandage OTC have been previously submitted in the referenced predicate device submissions."

Therefore, for this specific submission K043050, a new test set was not used. The data provenance and sample sizes would be found in the predicate submissions (K023298 for HemCon® Bandage and K030946 for HemCon® Bandage OTC), which are not provided in this document.

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

Not applicable for this 510(k) submission, as it relies on previously submitted data.

4. Adjudication Method for the Test Set

Not applicable for this 510(k) submission, as it relies on previously submitted data.

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 device is a hemostatic bandage, not an AI-powered diagnostic device involving human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Based on the description of the device (hemostatic bandage), the ground truth for performance in the predicate device studies would likely involve:

• Clinical outcomes data: Direct observation of hemostasis (cessation of bleeding) in human or animal subjects for the hemostatic claims.
• Laboratory test results: For antibacterial properties (AATCC Test Method 100-2004) and biocompatibility.
• Sterilization validation data: For sterility claims (ISO 11137).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a machine learning algorithm requiring a training set.

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

Not applicable for the same reason as above.

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The HemCon™ Bandage OTC Is indicated for the local management of bleading such as laceration and minor bleeding.

The HemCon™ Bandage OTC is manufactured from chilosan, a material consisting of callulosic polymer, poly-N-acetylgiucosamine. The HemCon™ Bandage OTC device is packaged in a foll package and are provided sterile.

The provided document is a 510(k) premarket notification for the HemCon™ Bandage OTC. It confirms the device's substantial equivalence to predicate devices and does not contain detailed information about a specific study proving acceptance criteria. Instead, it refers to performance data previously submitted for a referenced device.

Therefore, many of the requested elements about acceptance criteria, study design, and ground truth cannot be extracted directly from this document. However, I can infer some points based on the nature of a 510(k) submission for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly state acceptance criteria or provide a table of reported device performance. For a device like a hemostatic bandage, common performance criteria would likely revolve around its ability to stop bleeding, biocompatibility, and safety. The document states:

• "Performance data for the HemCon™ Bandage OTC has been previously submitted in the referenced device submission."
• "In summary, the HemCon™ Bandage OTC is expected to achieve the same safety and effectiveness as the predicate devices mentioned above."

Therefore, the acceptance criteria would implicitly be that the device performs equivalently to the predicate devices in terms of safety and effectiveness for its intended use (local management of bleeding such as laceration and minor bleeding).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided text. A 510(k) summary typically doesn't include specific details on sample sizes or data provenance for studies, especially if relying on previous submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided text. For a medical device like a bandage, clinical trials or material safety tests would typically involve medical professionals (e.g., surgeons, emergency room physicians) if human studies were conducted, or lab personnel for bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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 document describes a hemostatic bandage, not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.

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

This is not applicable as the HemCon™ Bandage OTC is a physical medical device, not an algorithm, and does not involve human-in-the-loop performance in the context of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated. For a hemostatic bandage, ground truth would likely be established through objective measures of bleeding cessation, wound healing, safety (e.g., infection rates, allergic reactions), and biocompatibility, often compared against established standards or predicate device performance. Outcomes data (e.g., time to hemostasis, adverse event rates) would be a key component.

8. The sample size for the training set

This information is not available in the provided text, as this is a physical medical device and the concept of a "training set" (as used in machine learning) does not apply in the same way. Performance data would likely come from pre-clinical (in vitro, in vivo animal) and possibly clinical human studies.

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

This information is not available in the provided text for the reasons mentioned in point 8.

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HemCon™ Bandage is a hemostatic dressing for the external temporary control of severely bleeding wounds intended for emergency use. In addition, the HemCon™ Bandage also controls bleeding in patients following hemodialysis.

The HemCon™ Bandage is applied to the wound and held in place until it adheres to the wound and hemostasis is achieved. Then, an outer bandage is applied to secure the dressing on the wound site. The HemCon™ Bandage is manufactured from ChitoClear™ chitosan ,a material consisting of cellulosic polymer, poly-N-acetylglucosamine. This device is packaged in a foil package and is provided sterile. It is sterilized by gamma irradiation at 15 kGy ensuring a SAL of 10°.

This document is a 510(k) summary for the HemCon™ Bandage, which means it describes the device's substantial equivalence to existing legally marketed devices rather than providing detailed clinical study results and acceptance criteria as would be found in a Premarket Approval (PMA) application. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not explicitly detailed in the provided text.

However, based on the information available in the 510(k) summary, here's what can be inferred and stated:

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

The document does not explicitly state quantitative acceptance criteria. Instead, it relies on demonstrating that the HemCon™ Bandage "out-performed the gauze control in all criteria" and showed "no statistical difference in the pre-injury animal characteristics" compared to predicate devices in animal models. The reported performance is qualitative and comparative rather than against predefined numerical thresholds.

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

The document states, "The HemCon™ Bandage has been tested in several settings utilizing accepted and approved animal models of hemorrhage..." However, it does not provide any specific sample sizes for these animal studies.

The data provenance is stated as "accepted and approved animal models of hemorrhage," implying animal studies rather than human clinical trials. The country of origin of the data is not specified. It is likely a retrospective analysis of animal study data submitted for 510(k) purposes.

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

This information is not provided in the 510(k) summary, as the studies mentioned are animal models, not human clinical trials requiring expert ground truth for interpretation of human data.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the type of animal studies described in a 510(k) for substantial equivalence.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant to this device. The HemCon™ Bandage is a hemostatic dressing, not an AI-powered diagnostic or assistive technology.

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

This concept is not applicable to the HemCon™ Bandage, as it is a physical medical device (hemostatic dressing), not an algorithm or AI system.

7. The type of ground truth used

For the animal studies, the "ground truth" would be the direct physiological outcomes measured in the animal models, such as actual blood loss, survival rates, and observed hemostasis. This is a form of outcomes data directly observed and measured in the study subjects (animals).

8. The sample size for the training set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to the HemCon™ Bandage. The reported "studies" are likely preclinical animal studies rather than data sets used to train a model.

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

As the concept of a training set is not applicable, this information is not provided.

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