(329 days)
HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.
This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
Models C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Simple Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, ENT Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.
HONGYU Disposable Surgical Drapes are devices made of synthetic material intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination. The drape is sterilized using ethylene oxide and is intended for single external use only.
This drape is classified as Level 4 per AAMI Standard PB70 liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.
HONGYU Disposable Surgery Drapes offer a variety of surgery drapes (23 types), including C-section Drape, Arthroscopy Drape, Bladder Drape, Split (U) Drape, Arm (Wrist) Drape, Miscellaneous Drape, Abdominal Drape, Shoulder Drape, Lithotomy Drape, Neck Drape, Fenestrated Drape, Simple Drape, Extremity Drape, Universal Drape, Head Drape, Craniotomy Drape, Buttock Drape, Dental Drape, ENT Drape, Pediatric Laparotomy Drape, Ophthalmic Drape, Angiography Drape and Articulation Drape.
The HONGYU Disposable Surgery Drapes have a basic drape. Additionally, each of the drapes has different drape components according to the intended clinical surgery sites, such as the reinforcement, fenestration, single-coating/ double-coating medical tape. PE film and Velcro-style line holders/ tube holders.
The provided text describes the regulatory clearance of a medical device (HONGYU Disposable Surgical Drapes) and includes a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device. However, it does not contain information about a clinical study involving human subjects or AI performance. Therefore, I cannot fully answer all aspects of your request, particularly those pertaining to AI assistance, human reader performance, training set, or ground truth derived from pathology/outcomes data.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-AI, non-diagnostic product, and its performance is evaluated against material properties and sterile barrier standards. The acceptance criteria are typically the standards themselves, and the reported performance is conformity to these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Barrier Performance: | |
| AAMI PB70-2012 (Level 4 liquid barrier performance) | Conforms to Level 4 |
| ASTM F1670-08 (Resistance to penetration by synthetic blood) | Conforms (implied by Level 4 and non-clinical test conclusion) |
| Flammability: | |
| 16 CFR Part 1610:2008 (Flammability of Clothing Textiles) | Class I |
| Mechanical Strength: | |
| ASTM D5034-09 (Breaking Strength and Elongation of Textile Fabrics) | Conforms (implied by non-clinical test conclusion) |
| ASTM D5587-08 (Tearing Strength of Fabrics) | Conforms (implied by non-clinical test conclusion) |
| Particle Generation: | |
| ISO 9073-10:2003 (Lint and Other Particles Generation in the Dry State) | Conforms (implied by non-clinical test conclusion) |
| Thermal/Evaporative Resistance: | |
| ASTM F1868-12 (Thermal and Evaporative Resistance of Clothing Materials) | Conforms (implied by non-clinical test conclusion) |
| Biocompatibility: | |
| ISO 10993-5:2009 (Cytotoxicity) | No Cytotoxic Potential |
| ISO 10993-10:2010 (Irritation) | No Primary Skin Irritation |
| ISO 10993-10:2010 (Sensitization) | Not a Dermal Sensitizer |
| Sterilization: | |
| ISO 11135-1:2007 (Ethylene oxide sterilization process) | Conforms (implied by non-clinical test conclusion and EO sterilization) |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Conforms (implied by non-clinical test conclusion) |
| Packaging Integrity: | |
| ASTM F88-05 (Seal Strength of Flexible Barrier Materials) | Conforms (implied by non-clinical test conclusion) |
| ASTM F1140-00 (2005) (Internal Pressurization Failure Resistance of Unrestrained Package) | Conforms (implied by non-clinical test conclusion) |
| ASTM F1929-98 (2004) (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Conforms (implied by non-clinical test conclusion) |
2. Sample size used for the test set and the data provenance
The document describes non-clinical tests on the device materials and packaging, not human studies. Therefore, there isn't a "test set" in the context of patient data. The samples would be batches of the surgical drape and its component materials. The document does not specify the number of samples tested for each non-clinical test. The provenance of the data is from Weihai Hongyu Nonwoven Fabric Products Co., Ltd in China, performing tests to demonstrate conformity to international and US standards. These tests are inherently retrospective in the sense that they are performed on manufactured products.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that relies on standardized material testing. "Ground truth" in this context refers to the defined parameters of the standards themselves (e.g., a material either passes a certain barrier test or it doesn't). No human experts are involved in establishing "ground truth" for each individual test sample; rather, the tests are performed by technicians/engineers following established protocols.
4. Adjudication method for the test set
Not applicable. As described above, there is no need for adjudication as these are objective material property tests against defined 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
Not applicable. This device is a surgical drape, 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 does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the performance of this device is established by international and national consensus standards for material properties, barrier performance, biocompatibility, and sterilization. For example, the "ground truth" for liquid barrier performance is a specified level (like Level 4) defined within the AAMI PB70 standard. "Pathology" or "outcomes data" are not relevant for the substantial equivalence demonstration of this type of device.
8. The sample size for the training set
Not applicable. This is a non-AI product, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.