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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the International Medsurg Connection Surgical Drape:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly lists the tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. The phrase "All material used in the fabrication of the IMC Surgical Drapes were evaluated for" followed by the list of tests strongly suggests that the device met the requirements of these standards. However, specific quantitative performance data for each test (e.g., actual hydrostatic pressure achieved) is not provided in this summary.

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

The provided text does not include information on:

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

The tests listed are material property tests rather than clinical studies on patient data.

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

This information is not applicable to the type of testing described. The tests are laboratory-based material property assessments against established industry standards (ISO, AATCC, ASTM, CFR). Ground truth in this context is defined by the specifications and methodologies within these standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable. As discussed above, the tests are objective laboratory evaluations against material standards, not analyses requiring expert adjudication.

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 done and is not relevant for this type of device (surgical drapes). This device is a physical barrier, not an AI or diagnostic tool that would involve human readers interpreting data.

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

No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical product, not a software algorithm. The tests performed are for material properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is scientific and engineering standards and specifications. For instance:

• ISO 10993 (Biocompatibility): Standards define acceptable levels of cytotoxicity, irritation, and sensitization based on established biological safety principles.
• 16 CFR Part 1610 (Flammability): Federal regulations specify flammability performance requirements for textiles.
• AATCC (Textile Chemistry): Standards provide methodologies and criteria for properties like hydrostatic pressure and impact penetration.
• ASTM (Materials Testing): Standards outline methods for evaluating tensile strength.

The "ground truth" is adherence to these widely accepted and documented industrial standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

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International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).

The International Medsurg Connection Fluid Collection Under Buttocks Drape.

The International Medsurg Connection Fluid Collection Under Buttocks Drape was tested for biocompatibility to demonstrate its safety. The acceptance criteria and the device performance are shown in the table below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each biocompatibility test. It indicates that "International Medsurg Connection Fluid Collection Under Buttocks Drape were tested," implying a sufficient number of samples were used to meet the requirements of the standards. The data provenance is not specified, but these are standard in-vitro and in-vivo biocompatibility tests, typically performed in a laboratory setting.

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

For biocompatibility testing according to ISO 10993 standards, "ground truth" is established by adherence to standardized protocols and interpretation by trained laboratory technicians and toxicologists. The document does not specify the number or specific qualifications of these experts, but it is implied they are qualified to conduct and interpret tests according to international standards.

4. Adjudication method for the test set:

Not applicable in the context of standard biocompatibility testing. The results are typically objectively measured and interpreted according to the specific criteria of each ISO standard.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret results, and it is not relevant for a fluid collection drape.

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

Not applicable. This device is a fluid collection drape, not an algorithm or a diagnostic tool. The performance evaluated here is related to its material safety.

7. The type of ground truth used:

The ground truth used for these tests is based on established biological safety endpoints and objective measurements defined by the ISO 10993 series of standards for biological evaluation of medical devices. For example:

• Cytotoxicity: Cell viability and morphology compared to controls.
• Skin Sensitivity: Presence or absence of delayed hypersensitivity reactions.
• Skin Irritation: Erythema and edema scores compared to controls.
• Systemic Toxicity: Clinical observations, body weight, organ weights, and histopathology.

8. The sample size for the training set:

Not applicable. Biocompatibility testing does not involve training sets in the same way machine learning algorithms do. The tests are designed to assess the intrinsic biological properties of the material.

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

Not applicable, as there is no training set in the context of these biocompatibility tests. The "ground truth" for evaluating the safety of the device's materials is established by the well-defined methodologies and criteria specified in the ISO 10993 standards.

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