Search Results

Ask a specific question about this device

PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma;
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• Help control minimal bleeding following surgery or trauma;
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• Act as an adjunct to aid in the natural healing process

PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy.

PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents.

PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.

The provided text is a 510(k) summary for a medical device called PosiSep® X BAM Hemostatic Dressing/Intranasal Splint. It describes the device, its intended use, and how its substantial equivalence to a predicate device (Hydrofera Bacteriostatic Nasal Dressing) was demonstrated. However, this is NOT a study that evaluates an AI/ML powered device, nor does it contain acceptance criteria or study results for such a device.

The information you requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are typically found in the clinical study report or performance evaluation section of an AI/ML device submission. This document does not contain any of that information.

The document describes performance bench testing for antimicrobial activity of the PosiSep® X BAM device, but this is a physical/chemical performance test of a traditional medical device, not an evaluation of an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information from the given text because it is not relevant to an AI/ML device.

Ask a specific question about this device

PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.

This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.

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

The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:

• Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
• Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
• Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).

The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.

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

This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as the device is a physical medical dressing, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm requiring a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

Ask a specific question about this device

OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.

The Hemostasis OsteoSeal® Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, OsteoSeal® forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. OsteoSeal® is based upon known biodegradable polymeric chemistry that forms a ready-to-use bone hemostatic agent. OsteoSeal® Bone Hemostat consists of a dispersion of hydroxyapatite particles within a proprietary synthetic polylactic acid polymer. The material is virtually odorless, off-white in color and can be spread easily. OsteoSeal® is available in two forms: a bone hemostat ingot and a bone hemostat stick in an applicator. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone, while the applicator allows direct application of the bone hemostat to the bleeding area.

The provided document is a 510(k) premarket notification for the OsteoSeal® Bone Hemostat. It describes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided in the document:

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

The document does not provide a formal table of "acceptance criteria" with specific quantitative targets. Instead, it refers to "product specifications" and general performance evaluations.

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

• Sample Size (Animal Studies):
  • Acute Porcine Animal Model: Not specified, only referred to as "an acute porcine animal model."
  • 13-week Rabbit Implant Study: Not specified, only referred to as "a 13 week rabbit implant study."
• Data Provenance: The document does not specify the country of origin for the animal studies or whether they were retrospective or prospective. Given the context of a 510(k) submission, these would typically be prospective studies conducted in a controlled environment (e.g., contract research organization).

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 provided in the document. The studies are animal models and bench tests, not human reader studies requiring expert consensus or ground truth establishment in the clinical sense. Pathological safety in the rabbit study would likely be assessed by a veterinary pathologist, but details are not given.

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

This information is not applicable and therefore not provided. The studies described are not "test sets" in the context of diagnostic performance involving human interpretation or adjudication.

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 information is not applicable and therefore not provided. The device (bone hemostat) is not an AI diagnostic tool and does not involve human readers in the way an MRMC study would assess.

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

This information is not applicable. The device is a physical medical device (bone hemostat), not an algorithm or AI system.

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

• For the hemostasis and placement retention in the acute porcine model, "product specifications" served as the basis for evaluation, implying predefined objective measures or expert veterinary assessment of outcomes. The "control" was a standard commercially available bone wax.
• For the pathological safety (tissue irritation and bone healing) in the 13-week rabbit implant study, histopathological examination would be the ground truth, comparing the device to a control bone wax. This is a form of pathology data.
• For the bench testing (appearance, handling, applicator function, melt point), the ground truth would be engineering specifications and direct measurements/observations.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and therefore not provided, as there is no "training set" for this type of device.

Ask a specific question about this device

PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• · Separate tissue or structures compromised by surgical trauma;
• · Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• · Help control minimal bleeding following surgery or trauma;
• · Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• · Act as an adjunct to aid in the natural healing process

PosiSep™ and PosiSep™ X are indicated for use as a nasal hemostat to treat epistaxis.

PosiSep" and PosiSep" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellulose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep" X Hemostat Dressing/Intranasal Splint have the material composition as the currently market cleared Hemostasis PosiSep™ and PosiSep Topical Hemostat. The PosiSep " and PosiSep" X Hemostat Dressing /Intranasal Splint are used for topical wounds and placed in the nasal cavity after surgery or trauma for the treatment of bleeding and as a space occupying stent to separate sinus tissue and prevent adhesions between mucosal surfaces. The dressings quickly dehydrate blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

PosiSep™ and PosiSep™X are removed from the sight of application by natural excretion and routine flushing to eliminate the material from the nasal cavity and avoid the issues involved with physical removal of a non-fragmenting dressing.

I cannot provide a table of acceptance criteria and reported device performance from the provided text, as the document is a 510(k) summary for a medical device (PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint) and does not contain specific acceptance criteria or detailed performance data in a measurable format.

The document primarily focuses on establishing substantial equivalence to predicate devices for FDA clearance. It mentions "Design verification testing was performed... to demonstrate physical and functional requirements were met" and "Animal and bench testing demonstrated appropriate hemostatic and tissue separation properties," but it does not quantify these requirements or the specific results against numerical acceptance criteria.

Also, the document does not describe a study involving an algorithm or human-in-the-loop performance, as this device is a physical medical dressing/splint, not an AI or digital health device. Therefore, questions related to test sets, ground truth, expert opinions, MRMC studies, or training sets are not applicable to this submission.

Here's an overview of the information that can be extracted from the document:

• Type of Device: Hemostat Dressing/Intranasal Splint (physical medical device).
• Purpose: To control minimal bleeding, separate tissues, prevent adhesions, and aid healing after nasal/sinus surgery or for epistaxis.
• Key components: Modified Chitosan particles and polysaccharide binders.
• Study Types mentioned (but not detailed with acceptance criteria or results):
  • Biocompatibility testing (ISO 10993 and FDA guidance)
  • Sterilization validation (gamma radiation to SAL of 10^-6)
  • Performance Bench Testing (for physical and functional requirements)
  • Animal testing (for hemostatic and tissue separation properties)

Without specific numerical data, I cannot populate the table or answer questions about metrics like sample sizes for test/training sets, adjudication methods, or expert qualifications, as these are not present in the provided 510(k) summary for this type of device.

Ask a specific question about this device

NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The Hemostasis NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.

The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are identical to the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of polysaccharide hemostatic particles is being changed for the NexStat® Plus and NexFoam® Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as NexStat® and NexFoam®. The indications for use remain the same as NexStat® and NexFoam®

The provided text is a 510(k) summary for the NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets those criteria with statistical data.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in the document. The 510(k) summary states that "Design verification testing was performed on NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge to demonstrate physical and functional requirements were met," but it does not specify what those requirements or acceptance criteria were, nor does it present the results in detail.

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

• Not provided in the document. The document mentions "Design verification testing" but does not detail the sample size for any test set or the provenance of the data. Given it's a 510(k) for a topical hemostat, the testing would likely involve in-vitro or in-vivo animal models, but specifics are absent.

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

• Not applicable / Not provided in the document. This type of information is typically relevant for studies involving subjective interpretations (e.g., imaging diagnostics). For a hemostatic device, ground truth would likely be based on objective measures of bleeding control, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided in the document. Similar to point 3, adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions. This is not typically relevant for the performance evaluation of a hemostatic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, not explicitly stated or implied. MRMC studies are primarily for evaluating diagnostic devices where reader variability is a factor. This document concerns a hemostatic device, not a diagnostic one, and there's no mention of human readers evaluating the device's performance in a comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Not applicable / Not provided in the document. This question is usually for AI-powered devices. The NexStat® Plus and NexFoam® Plus are physical hemostatic devices, not algorithms.

7. The Type of Ground Truth Used:

• Implied objective measures, but not specified. For hemostatic devices, ground truth for performance would typically be objective measures such as time to hemostasis, amount of blood loss, or success/failure of bleeding control, likely established in bench or animal models. The document only generically refers to "physical and functional requirements."

8. The Sample Size for the Training Set:

• Not applicable / Not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device. The development process would involve formulation, material characterization, and performance testing.

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

• Not applicable / Not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth establishment methods (like expert annotations) does not apply.

In summary, the provided document is a 510(k) letter and summary emphasizing "substantial equivalence" to predicate devices. It highlights that design verification testing was performed and requirements were met, and biocompatibility and sterilization were evaluated, but it does not delve into the specific details of acceptance criteria or the study data proving those criteria were met, which is common for a 510(k) submission focused on equivalence rather than de novo approval or clinical superiority. This level of detail is typically found in the full submission, not the summary publicly available without redaction.

Ask a specific question about this device

PosiSep " and PosiSep" X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSep"" and PosiSep"" X are intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep™ and PosiSep™X Hemostat Dressings are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellylose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep™ X Hemostat Dressings have the identical material composition as the currently market cleared Hemostasis ExcelArrest Topical Hemostat. The PosiSep " and PosiSep " X Hemostat Dressings are used for topical wounds. The dressings quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

The provided text describes the 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it relies on a "substantial equivalence" argument to predicate devices.

The available information regarding testing is general:

• Biocompatibility testing was performed using ISO 10993 and FDA guidance.
• Sterilization was validated using gamma radiation to assure a sterility assurance level (SAL) of 10⁻⁶.
• Performance Bench Testing was performed for PosiSep™ X Hemostat Dressings to demonstrate physical and functional requirements were met.

Since specific performance data and acceptance criteria are not explicitly detailed in the provided text, the response below will reflect the lack of this information.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings does not explicitly state specific acceptance criteria or report detailed device performance results in a manner that would typically be seen in a clinical or robust standalone performance study demonstrating adherence to pre-defined criteria.

Instead, the submission primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "Conclusion" section states, "Through the data and information presented, Hemostasis, LLC considers the PosiSep™ and PosiSep™ X Hemostat Dressings substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness."

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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

   Acceptance Criteria	Reported Device Performance
   Functionality	"Physical and functional requirements were met" (for PosiSep™ X Hemostat Dressings based on Performance Bench Testing). However, no specific metrics or thresholds are provided.
   Biocompatibility	"Pass the biocompatibility requirements for their intended use" based on ISO 10993 and FDA guidance. No specific test results or acceptance values are given.
   Sterility	Sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10⁻⁶. This implies meeting the SAL requirement.
   Hemostatic Efficacy	No specific performance metrics (e.g., time to hemostasis, percentage of successful hemostasis) or acceptance criteria are reported in this document. The claim is based on being substantially equivalent to predicates known for hemostatic properties.

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

   • Sample Size: Not specified for any of the mentioned tests (Biocompatibility, Sterilization, Performance Bench Testing).
   • Data Provenance: Not specified.

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)

   • Not applicable/Not specified. The provided document points to bench testing and biocompatibility assessments, not a study involving expert-established ground truth for performance.

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

   • Not applicable/Not specified. This is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

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 topical hemostat dressing, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is not an algorithm or AI system. Its performance evaluation would be through bench testing, in-vitro, or in-vivo (animal or human) studies. The document only vaguely mentions "Performance Bench Testing" for "physical and functional requirements."

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

   • Not explicitly defined in the provided document for its performance claims. For biocompatibility, the "ground truth" would be the established acceptable limits for biological response as defined by ISO 10993. For sterilization, it's the demonstration of SAL 10⁻⁶. For hemostatic efficacy, the document does not provide details on how "ground truth" was established, relying instead on substantial equivalence.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML model that requires a training set.

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

   • Not applicable. This device is not an AI/ML model that requires a training set.

Ask a specific question about this device

NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.

The provided text is a 510(k) summary for the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge. It describes the device, its indications for use, and claims substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study with detailed performance metrics.

However, based on the information provided, we can infer some aspects and highlight what is missing regarding the acceptance criteria and a detailed study.

Here's an analysis of the provided information against your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Critique: The document states that the devices met these criteria without providing the specific quantitative thresholds for "passed," "validated," "met," or "substantially equivalent." For instance, it doesn't specify what level of hemostasis (e.g., time to hemostasis, volume of blood loss) was considered "substantially equivalent" to the predicates.

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

• Sample Size for Test Set: This information is not provided in the document. The "comparative hemostasis testing in an animal model" doesn't specify the number of animals or the number of test applications.
• Data Provenance: The study was conducted as "comparative hemostasis testing in an animal model." The country of origin of the data is not specified, but given the submitter (Hemostasis, LLC) is located in St. Paul, Minnesota, and the submission is to the FDA, it is highly likely the data was generated in the United States. The study type is prospective in nature, as it was specifically conducted for this 510(k) submission to demonstrate performance.

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

• This information is not applicable as the ground truth was established through animal model performance testing, not human expert consensus on diagnostic images or clinical assessments requiring multiple expert reviewers.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established through animal model performance testing, not human expert consensus.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human reader performance is augmented by AI. The NexStat® and NexFoam® are topical hemostats, not AI-powered diagnostic tools.

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

• No, this is not applicable. The device is a physical hemostat, not an algorithm. Its performance is inherent to its physical and chemical properties and interaction with blood, not an algorithmic output. The "animal model" testing is a standalone test of the device itself.

7. The Type of Ground Truth Used

• The primary ground truth for performance was established through direct observation and measurement of hemostasis in an animal model. This would likely involve metrics such as time to hemostasis, blood loss, and potentially the quality of the resulting clot, or comparison to a control/predicate device under controlled experimental conditions.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The "design verification testing" and "animal model" testing are evaluation studies, not training sets.

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

• This information is not applicable as there is no "training set" for this physical medical device.

Ask a specific question about this device

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.

Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations.

The provided text is a 510(k) summary for a medical device called ExcelArrest™ Foam Hemostat Bandage. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with reported numerical performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this document.

However, I can extract the information that is present:

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

This document does not provide a table of specific numerical acceptance criteria for performance metrics (e.g., clotting time, blood loss reduction). Instead, it states that the device "met the performance criteria" in a porcine model. The acceptance criteria are implicitly defined by the performance of the predicate devices.

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

• Sample Size for Test Set: Not specified. The document only mentions "a Porcine Model" without detailing the number of animals or trials.
• Data Provenance: Porcine Model (animal study). Specific country of origin is not mentioned, but it's likely a controlled laboratory setting. The study appears to be prospective as it's comparative testing being performed for the submission.

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

Not specified. Animal studies typically rely on veterinary assessment or quantitative measurements, rather than human expert consensus for "ground truth" in the way clinical studies do.

4. Adjudication method for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The performance testing was conducted in a porcine model, not involving human readers.

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

This device is a physical medical device (hemostatic bandage), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.

7. The type of ground truth used:

The ground truth for the performance testing in the porcine model would be based on direct physiological measurements of hemostasis (e.g., time to hemostasis, blood loss volume) as observed and measured by researchers during the animal study.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

Ask a specific question about this device

The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.

Prescription: TraumArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, · dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites.

OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.

As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations,

The provided text is a 510(k) summary for the TraumArrest™ and BleedArrest™ devices. It describes the devices, their intended use, and establishes substantial equivalence to predicate devices. However, this document does not report on a study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Instead, it states that:

1. "Comparative testing was performed using a Porcine Model and the devices met the performance criteria." This indicates a study was done, and it was successful, but the specific acceptance criteria and the results are not detailed.
2. "Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices." This is a statement of belief based on the comparative testing, but again, without specific data.
3. "Performance Standards: N/A" This means there are no formal, recognized performance standards for this type of device that the manufacturer had to meet.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth are not present in the provided document.

Here's an attempt to answer the questions based on the limited information available:

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

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

• Sample Size: Not specified.
• Data Provenance: The study was a "Porcine Model," indicating an animal study rather than human clinical data. The location of the study (country) is not specified. It would be prospective since it's an experimental study.

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)

• Not specified. The nature of a porcine model study typically involves veterinary experts or researchers, but this is not detailed.

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

• Not specified.

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

• No. This device is a topical hemostat, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human reader improvement with AI is not applicable.

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

• This question is not applicable as the device is a physical hemostat, not an algorithm.

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

• For the "Porcine Model," the ground truth would likely be direct observation of hemostasis, measurement of blood loss, or time to hemostasis, as assessed by the researchers or veterinary staff involved in the study. This constitutes "outcomes data" in an animal model context.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable as there is no training set for this type of physical medical device.

Ask a specific question about this device