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Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip.

Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.

This document, a 510(k) Premarket Notification for the Celox Rapid X-Ray Gauze, describes the device and its claimed substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human reader performance study.

The provided document is for a hemostatic gauze, not an AI-powered medical device or software. Therefore, many of your questions, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this document. The "Performance Data" section in the document refers to in-vitro and in-vivo (animal) testing related to the physical and biological performance of the gauze itself, not the performance of an AI algorithm.

Based on the provided document, here's what can be extracted, acknowledging the limitations:

Acceptance Criteria and Device Performance (as covered by this document)

The document focuses on demonstrating that the new device, Celox Rapid X-Ray Gauze, is substantially equivalent to existing predicate devices, particularly the Celox Rapid Gauze (K110386), with the key difference being the addition of an X-ray detectable strip. The acceptance criteria, in this context, are primarily related to confirming that this modification does not negatively impact the device's hemostatic function and that it remains safe and effective for its intended use.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Hemostatic Gauze)

Given this is a physical medical device (hemostatic gauze), not an AI, the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or AUC. Instead, they are about functional performance and safety.

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Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.

The product is a chitosan-based haemostatic agent presented in a granular form in a sealed pouch. It is applied directly to the source of bleeding in a topical wound and pressure applied for up to 3 minutes until hemostasis is achieved. Bondiloxs Topical Hemostatic Granules achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, Bondiloxs Topical Hemostatic Granules quickly forms a strong seal that completely covers the wound.

The provided document is a 510(k) summary for the Bondiloxs Topical Hemostatic Granules. It details the device's comparison to a predicate device and includes information about performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds. Instead, it describes performance characteristics and states that the device's performance was "adequate to support a determination of substantial equivalence to the predicate." The acceptance criterion effectively is that the Bondiloxs Topical Hemostatic Granules performs equivalently to the predicate device, CELOX Pro, in relevant tests.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the animal (porcine) bleeding model tests. It refers to "representative wound models."
• Data Provenance: The studies appear to be prospective in nature, as they involve actively testing the device and predicate in bench and animal models. The country of origin for the data is not explicitly stated, but the manufacturer is Medtrade Products Ltd based in the United Kingdom.

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

This type of information is generally not applicable to the evaluation of a topical hemostatic granule device where performance is assessed through objective measurements (e.g., stopping bleeding, plug formation, adhesion strength, biocompatibility assays) rather than expert interpretation of images or clinical outcomes requiring consensus. The ground truth would be established by the experimental setup and objective measurements.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies involving human interpretation where disagreements need to be resolved. Performance was assessed through objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a topical hemostatic medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation would have been conducted.

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

Not applicable, as this is not an algorithm or AI-based device. The device itself is a standalone product.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Objective Measurements: Such as the observation of hemostasis (stopping of bleeding), gel plug formation, and adhesion strength in bench and animal models.
• Standardized Biological and Sterilization Testing: Compliance with ISO 10993 and ISO 11137 standards for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) and sterilization validation.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance was evaluated against a predicate device.

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

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

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Under the supervision of a healthcare professional Bondiloxs Topical Hemostatic Dressing is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate to severe bleeding.

Bondiloxs Topical Hemostatic Dressing is a sterile non-woven dressing comprising of chitosan fibres which aids the gelling and absorbency potential of the dressing. Bondiloxs Topical Hemostatic Dressing achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the Bondiloxs Topical Hemostatic Dressing directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding. The dressing promotes localized clotting formation to help stop bleeding. The Bondiloxs Topical Hemostatic Dressing is packed in a foil/foil pouch. The pouch provide an integral barrier that maintains dressing sterility post irradiation vet allows easy opening and aseptic dressing removal by the end user. The Bondiloxs Topical Hemostatic Dressing is available in various sizes ranging up to a maximum of 15cm x 15cm and is available in a flat dressing or z-folded for fast and intuitive application.

The provided document is a 510(k) summary for the Bondiloxs Topical Hemostatic Dressing. It aims to demonstrate substantial equivalence to a predicate device, CELOX Gauze PRO (K113560), rather than outlining acceptance criteria and a study proving the device meets those criteria from scratch. Therefore, much of the requested information regarding specific acceptance criteria, test set details, expert involvement, and ground truth establishment is not explicitly present.

However, I can extract the available information and highlight what is missing based on your request:

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

The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the Bondiloxs device is "as safe and effective as" and "substantially equivalent to" the predicate device, CELOX Gauze PRO. The performance data is described qualitatively.

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 quantitatively in the document. The in-vivo studies mention "different injury types" and "various animal models," but no number of animals or trials.
• Data Provenance: The studies are described as "in-vivo studies" and "bench testing." No country of origin for the data is explicitly stated. The nature of the studies implies prospective experimental design (animal models and bench tests).

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. The ground truth for performance in this context is based on direct observation of hemostasis in animal models and objective measurements in bench tests, not on expert adjudication of diagnostic interpretation.

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

Not applicable, as the evaluation is based on direct measurement of physiological outcomes (hemostasis) and physical properties, not on subjective interpretations requiring 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

Not applicable. This device is a topical hemostatic dressing, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or is relevant for this type of device.

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

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

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

The ground truth for the "hemostatic efficacy" performance would be considered outcomes data from the animal models (i.e., whether bleeding was controlled or stopped). For other properties (absorbency, tensile strength, sterility), the ground truth is established by objective measurements against physical/chemical standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as: A hydrophilic foam patch that is used to absorb exudates and to cover the peri-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

The Medtrade Product Ltd CHG Antibacterial Foam Patch consists of a hydrophilic Polyurethane absorbent foam with chlorhexidine gluconate (CHG) and a thin Polyurethane backing. The foam material absorbs up to eight times its own weight in fluid. The CHG present in the dressing inhibits or kills microorganisms on the surface of the dressing.

The provided documentation describes a 510(k) submission for the Medtrade Products Ltd CHG Antibacterial Foam Patch. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials to establish novel performance criteria. Therefore, the device performance is primarily assessed against the predicate device's established uses and through in-vitro and bench testing to show it meets its own specifications and is safe and effective for its intended use.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Staphylococcus aureus (MRSA) NCTC 13142
• Escherichia coli ATCC 8739
• Pseudomonas aeruginosa ATCC 9027
• Enterococcus faecalis NCTC 12201
• Staphylococcus aureus ATCC 6538 |
  | Biocompatibility | In compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) |
  | Sterilization | Performed in compliance with harmonized standards |
  | Manufacturing Quality | Meets all established specifications; manufactured under GMP; risk analysis (BS EN ISO 14971) performed and controls implemented |
  | Absorption Capacity | Hydrophilic foam absorbs up to eight times its own weight in fluid |

Note on "Acceptance Criteria" for a 510(k): For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating that the device is as safe and effective as the predicate device, and that its in-vitro and bench testing results meet its own internal specifications and relevant standards. There isn't a "clinical study" in the traditional sense with specific clinical endpoints and acceptance thresholds for clinical performance in humans, as you might see in a PMA or a more novel device.

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

• Sample Size for Test Set: Not explicitly stated for specific tests. The antibacterial data refers to "organisms" which implies laboratory strains, not human patient samples.
• Data Provenance: The antibacterial and bench testing are in-vitro (laboratory) and bench studies, meaning they are not derived from human patients or a specific country of origin in a clinical context.

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

• This information is not applicable and not provided. The testing described is in-vitro (lab-based antibacterial efficacy) and bench testing (physical properties, biocompatibility, sterilization). These types of tests do not involve human experts establishing a "ground truth" through interpretation (e.g., radiologists reviewing images). Instead, results are determined by laboratory measurements and adherence to specified standards.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As noted above, the testing is in-vitro and bench testing, not clinical with expert review of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with/without AI Assistance

• No. This is a medical device (foam patch), not an AI/imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No. This question applies to AI algorithms. This device is a physical medical dressing.

7. The Type of Ground Truth Used

• Antibacterial Testing: The "ground truth" would be the direct measurement of microbial reduction (e.g., Log reduction) in laboratory conditions following established microbiological protocols.
• Biocompatibility: Adherence to the requirements of the standard BS EN ISO 10993-1.
• Sterilization: Compliance with harmonized standards.
• Absorption: Direct measurement of fluid absorption capacity.

8. The Sample Size for the Training Set

• This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical product undergoing in-vitro and bench testing.

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

• This information is not applicable for the same reasons as above.

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Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.

Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.

CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.

CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet (510(k) # K080097) in product composition (raw materials), manufacturing processes and product performance. The device consists of a chitosan Haemostatic granules (CELOX PRO 510(k) # K093593) adhered onto a base fabric (non-woven gauze) using a hot melt adhesive.

CELOX Gauze PRO achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the CELOX Gauze PRO directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding and reduce the risk of re-bleeding.

In addition because CELOX Gauze PRO absorbs water from blood, platelets are concentrated, resulting in activation of platelets to help stop bleeding and reduce the risk of re-bleeding

CELOX Gauze PRO is an effective solution that reduces time to haemostasis, even for patients on anticoagulants such as warfarin and heparin.

The CELOX Gauze Pro is packed in a three layer laminate pouch of polyester, aluminium and LDPE. The pouch provide an integral barrier that maintains dressing sterility post irradiation yet allows easy opening and aseptic dressing removal by the end user.

The CELOX Gauze PRO is available in various sizes ranging from 1" x 1" to 3″ x 10ft.

The provided text is a 510(k) summary for the CELOX Gauze PRO device. It outlines the device description, indications for use, and a general statement of testing performed to establish substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific study designs, or quantitative results of performance studies that would allow for a complete response to the requested information.

The document focuses on demonstrating substantial equivalence based on product composition, manufacturing processes, and the general principle of hemostasis, rather than providing a detailed report of clinical or performance study outcomes against specific acceptance criteria.

Therefore, for many of the requested points, the information is not present in the provided text.

Here's what can be extracted and what is missing:

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

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 for Test Set: Not specified.
• Data Provenance: Not specified. The studies mentioned are "in-vivo testing and bench testing" and "biocompatibility... in compliance with the requirements of BS EN ISO 10993-1." It does not indicate where these tests were conducted or if they were retrospective or prospective.

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 document refers to "in-vivo testing and bench testing" and biocompatibility testing, not studies requiring expert interpretation of results for ground truth establishment in a clinical setting.

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 requiring consensus, 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 hemostatic gauze, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a hemostatic gauze; there is no algorithm or AI component.

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

• For the "in-vivo testing and bench testing" and biocompatibility, the ground truth would typically be established by established laboratory methods, validated assays, and adherence to international standards (e.g., ISO 10993 for biocompatibility) for measuring specific biological responses or physical/chemical properties. No specific "expert consensus" or "pathology" is mentioned in this context. Outcome data is implied through the statement of efficacy in hemostasis, but detailed metrics are absent.

8. The sample size for the training set

• Not applicable. This device is a hemostatic gauze; there is no training set in the AI/machine learning sense.

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

• Not applicable. As there is no training set mentioned or implied for an AI/ML device.

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CELOX Rapid Gauze (Rx) is indicated for temporary external use to control moderate to severe bleeding.

CELOX Rapid Gauze (OTC) is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Components – CELOX Rapid is composed of chitosan

Mechanism of Action - CELOX Gauze achieves its principle intended action (hemostasis) by acting as a delivery system for the Celox Granules creating a physical barrier or seal to stop the flow of blood. When in contact with a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, the CLO. C Granules heat bonded on to the CELOX Rapid quickly form a strong seai that completely covers the wound.

The provided text describes the 510(k) submission for the CELOX Rapid Gauze device. It compares the device to its predicate, CELOX Hemostatic Granules on Sheet (K080097), and outlines performance testing that supports its substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of formal "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not explicitly stated or provided in this 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific quantifiable performance targets against a clinical ground truth.

Instead, the performance reported is framed in terms of supporting claims for the device.

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

• Test Set Description: The primary "test set" for efficacy assessment appears to be an animal study (Animal Study 1): "The efficacy of Celox Rapid Gauze in a femoral artery wound model."
• Sample Size: The precise number of animals used in Animal Study 1 is not specified in the provided text. It only mentions a "swine model of lethal arterial extremity."
• Data Provenance: The origin of the data (e.g., country) is not specified. The study is likely prospective, as it's an efficacy study for a new device.

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

• Not Applicable: This type of study (animal model for hemostasis) typically does not involve human expert readers establishing ground truth in the same way an imaging study would. The ground truth for hemostatic efficacy in an animal model is established by direct observation and measurement of bleeding cessation and blood loss during the experiment by the study's researchers/veterinarians.

4. Adjudication Method for the Test Set

• Not Applicable: Given that the primary efficacy data comes from an animal study and in vitro tests, a "2+1, 3+1" adjudication method is not relevant. The assessment of endpoints in these studies would be based on predefined objective criteria applied by the study investigators.

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

• No: A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic imaging devices with multiple human readers, often comparing AI-assisted performance to unassisted performance. The CELOX Rapid Gauze is a hemostatic device, not a diagnostic imaging AI algorithm.

6. Standalone (Algorithm Only) Performance

• Not Applicable: The CELOX Rapid Gauze is a physical medical device (hemostatic gauze), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant. Its performance is its direct physical action.

7. Type of Ground Truth Used

• Animal Outcomes/Physiological Response: For the animal study, the ground truth was the direct observation and measurement of hemostasis (cessation of bleeding) and control of hemorrhage in the swine model, along with potentially other physiological parameters like blood loss, under experimental conditions.
• Biocompatibility Standards: For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO10993 and FDA Blue Book memo G95-1).
• In Vitro Metrics: For in vitro tests (Rapid Packing, High Volume Gauze Strip, Promotes Rapid Wound Adhesion), the ground truth would be precise laboratory measurements using established protocols.

8. Sample Size for the Training Set

• Not Applicable: As the CELOX Rapid Gauze is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The device's design and mechanism of action are based on scientific principles of chitosan's hemostatic properties.

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

• Not Applicable: Since there is no training set as defined for AI algorithms, this question is not relevant. The "ground truth" for the device's development would stem from extensive research into material science, hemostasis, and preclinical testing over many years, culminating in its predicate device.

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CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.

CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-woven gauze dressing. This dressing is composed of Chitosan, Chitosan derivatives and structural woven gauze materials with the addition of Ionic Silver. The silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs high amounts of wound fluid and bacteria, conforms to the wound surface, maintains a moist and creates a soft, cohesive gel that aids in the removal of non-viable tissue (autolytic debridement). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.

This document is a 510(k) summary for the CELOX Antibacterial Trauma Gauze. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted directly from this document.

The document primarily states that the device is substantially equivalent to a predicate device (AQUANOVA Ag K100693 and CELOX Trauma Gauze K0917953) because it shares similar raw materials, manufacturing route, intended use, indications, product design, composition, and processing. The main difference highlighted is the addition of ionic silver as an antibacterial agent.

It also mentions that the product was "evaluated through standard biocompatibility tests (ISO 10993) and antimicrobial testing with appropriate organisms." However, it does not provide the specific acceptance criteria for these tests or the detailed results of the evaluations.

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CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.

The provided document describes the CELOX Vascular device and its substantial equivalence determination. Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity, specificity, or specific hemostasis rates to be achieved in a clinical trial). Instead, it describes demonstrating hemostasis and performance as effectively as a predicate device.

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

• Sample Size for Test Set: 11 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing. (The country of origin for the testing is not specified, but the company is based in the UK.)
• Retrospective/Prospective: The nature of "pre-clinical porcine model testing" typically implies a prospective design for the animal study itself.

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

This information is not provided in the document. The document refers to the results of a "pre-clinical porcine model testing" and the observation of "demonstrated hemostasis" and "successfully controlling all bleeding." The methods for assessing hemostasis and whether experts were involved in defining "ground truth" for the success of these procedures are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a pre-clinical animal (porcine) model assessing the device's ability to achieve hemostasis, not a study involving human readers or AI assistance.

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

This question is not applicable as the CELOX Vascular is a physical medical device (hemostatic pad and adhesive bandage), not an AI algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the device's performance (i.e., hemostasis) was established through direct observation and measurement of bleeding control in a pre-clinical porcine model. This can be considered outcomes data in an animal model context – the direct outcome being the cessation of bleeding.

8. The Sample Size for the Training Set

This question is not applicable. The CELOX Vascular is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

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CELOX Trauma Gauze is intended to be available Over The Counter for the following indication.
Indications For OTC (Over The Counter) Use:
CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorbent Dressing Rx & OTC cleared in K070175 on July 25, 2007

The provided document is a 510(k) summary for the MedTrade Products CELOX Trauma Gauze and CELOX Trauma Gauze OTC. It focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific performance acceptance criteria.

However, the document does mention one in vivo test:

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

The document does not specify quantitative acceptance criteria. It states:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (originating country, retrospective/prospective). The study is described as "in vivo testing," suggesting it was prospective.

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

Not applicable (the in vivo test likely involved direct observation of biological outcomes, not expert interpretation of results).

4. Adjudication method for the test set

Not applicable (no information on adjudication for the in vivo test).

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 not an AI/imaging device.

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

Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

The ground truth was likely direct observation of hemostasis in a "femoral artery wound model," which can be considered an outcome-based ground truth (the direct physiological response).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

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CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters

CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied.

For OTC use MedTrade Product's CELOX Topical Hemostatic Paste OTC is indicated for the topical external temporary use to control bleeding of lacerations, minor cuts and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied.

For professional use CELOX Topical Hemostatic Paste is indicated for the topical external temporary use to control moderate to sever bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters.

The product is designed and packaged to be easily packed, carried and applied. It is well suited for low to moderate eviscerating wounds, to create hemolysis by coagulation.

The CELOX Hemostatic Paste is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of the adjunctive manual compression. The CELOX Hemostatic Granules then cause hemostasis in which a natural blood clot can build and form a physical barrier to bleeding.

MedTrade Products CELOX Topical Hemostatic Paste is provided in sterile tubes. Packaging will consist of between 1g to 50g of Paste.

Biocompatibility testing summary has been provided.

The device is packed in a tube and is provided sterilized by gamma irradiation. The product will be sterilised by gamma irradiation in accordance with the Sterilisation of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilisation, 30 Edition (ANSI/AAMI/ISO11137-1994) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991). Qualification will be based on Method 1 for dosimetric release with a sterility assurance level of 10 ° The product will receive a dose of 25 kGys to 35kGys.

This document is a 510(k) summary for the MedTrade Products CELOX Topical Hemostatic Paste. It describes the device, its intended use, and claims substantial equivalence to a legally marketed predicate device (CELOX Topical Hemostatic Granules K061079).

Based on the provided text, there is no information about specific acceptance criteria or a study that rigorously tests the device's performance against those criteria. This type of regulatory document focuses on establishing substantial equivalence based on device description, intended use, and comparison to a predicate, rather than detailing full performance studies with acceptance criteria.

The document mentions "Biocompatibility testing summary has been provided," and details about sterilization, but these refer to general safety aspects rather than specific efficacy performance acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported device performance, or answer the subsequent questions about sample sizes, ground truth, expert involvement, or MRMC studies.

The provided text only contains:

• Device Name: MedTrade Products CELOX Topical Hemostatic Paste
• Intended Use (for OTC): Topical external temporary use to control bleeding of lacerations, minor cuts, and abrasions. It is intended for use to control minor bleeding and to absorb body fluid in superficial lacerations or wounds.
• Intended Use (for professional use): Topical external temporary use to control moderate to severe bleeding and the local management of surface bleeding from vascular access sites and percutaneous tubes for catheters.
• Legally Marketed Predicate Device: Celox Topical Hemostatic Granules K061079

There is no information regarding specific performance metrics such as time to hemostasis, percentage of successful bleeding control, etc., that would be associated with acceptance criteria and a detailed performance study.

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