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510(k) Data Aggregation
(270 days)
GCI surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification.
GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.
This document describes the non-clinical performance testing of the GCI Surgical Gown to demonstrate its substantial equivalence to a legally marketed predicate device (K211422).
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability | Meets Class 1 Requirements | Meets Class 1 Requirements |
| Water Resistance: Hydrostatic Pressure | Water Resistant ≥20 cm | Water Resistant ≥20 cm |
| Water Resistance: Impact Penetration | ≤1.0 g water | ≤1.0 g water |
| Breaking / Bursting Strength | ≥20 N | >20 N |
| Tearing Strength | ≥20 N | >20 N |
| Seam Strength | ≥20 N | >20 N |
| Linting | Log10 < 4 | Log10 < 4 |
| Biocompatibility | Biocompatible in alignment with ISO 10993-1 | Biocompatible in alignment with ISO 10993-1 |
| - Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the device is non-cytotoxic. |
| - Irritation | Non-irritating | Under the conditions of the study, the device is not an irritant. |
| - Sensitization | Non-sensitizing | Under the conditions of the study, the device is not a sensitizer. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test. However, the tests are laboratory-based performance tests of the device itself (GCI Surgical Gown). The data provenance is from non-clinical laboratory testing performed to specific standards (e.g., AATCC, ASTM, ISO) to verify the device met design specifications. The country of origin of the data is not explicitly stated, but the submission is to the US FDA by a Canadian company (George Courey, Inc.), suggesting the testing was performed to international standards. This is retrospective testing performed on the final device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the ground truth for this type of device (surgical gown) is established through objective, standardized physical and biological performance tests, not through expert human assessment of images or clinical data. The "ground truth" is defined by the acceptance criteria of the specified international standards.
4. Adjudication method for the test set
This section is not applicable. The outcome of non-clinical, objective tests is not subject to adjudication in the same manner as expert consensus for clinical image interpretation. The tests yield quantitative results that are compared directly against predefined numerical or qualitative acceptance criteria specified in the relevant standards.
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 section is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessment of human reader improvement with AI are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical surgical gown, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device is based on objective, standardized measurements and biological assessments as defined by international and national standards. For example:
- Physical properties (e.g., water resistance, strength) are evaluated against quantitative thresholds.
- Biocompatibility is evaluated against qualitative (e.g., "non-cytotoxic," "not an irritant") outcomes determined by specified in-vitro or in-vivo biological tests.
8. The sample size for the training set
This section is not applicable. The device is a physical product (surgical gown) that does not utilize machine learning or AI, and therefore does not have a "training set" in the computational sense.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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