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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.

Device Description

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.

AI/ML Overview

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.

Parameter	Acceptance Criteria (Not explicitly stated as quantitative targets)	Reported Device Performance
Hemostatic efficacy	To be equivalent to the predicate device in controlling bleeding in various injury types and severities.	Established using in-vivo testing in different injury types, including: Epigastric artery wound model (heparinized and non-heparinized), Liver cruciate model (mild to moderate bleeding), Liver dissection model (moderate bleeding), Epigastric sever model (mild topical bleeding), and Saphenous femoral 2.7mm punch (moderate to major bleeding). These models assessed the device's ability to control different severities of bleeding. The document concludes "The biocompatibility and performance testing including the in-vivo testing for the Bondiloxs Topical Hemostatic Dressing has demonstrated that the device is safe and effective for the indications of use."
Absorbency	To meet relevant standards.	Bench testing in accordance with relevant standards.
Tensile Strength	To meet relevant standards.	Bench testing in accordance with relevant standards.
Gelling Properties	To meet relevant standards.	Bench testing in accordance with relevant standards.
Pack Integrity	To be maintained (e.g., dye penetration and burst test).	Bench testing (dye penetration and burst test).
Sterility	Sterility Assurance Level (SAL) of 1x10^-6.	Achieved via terminal sterilization by gamma irradiation to a SAL of 1x10^-6, validated in compliance with ISO 11137-1:2006.
Biocompatibility	To be demonstrated in accordance with BS EN ISO 10993-1 (cytotoxicity, sensitization, irritation).	Demonstrated through assessment according to BS EN ISO 10993-1, including cytotoxicity, sensitization, and irritation testing. The testing "demonstrated that the device is safe for the indications of use."
Shelf Life	To be determined through stability studies.	Determined using stability studies at ambient conditions (real-time aging 25°C/60% RH) and in a controlled environment (40°C/75% RH). (Specific duration not provided in this summary).
Manufacturing Quality Controls	Compliance with GMP and ISO 14971 for risk analysis; device meets established specifications prior to release.	Bondiloxs Topical Hemostatic Dressing is manufactured according to product specifications and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971, and manufacturing controls developed and implemented. The device meets all established specifications prior to release.

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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