Search Results

The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:

• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.

There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.

Therefore, I cannot provide the requested information based on this document.

Ask a specific question about this device

Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named "Dental Barrier and Sleeves." It explicitly states that the device is a physical barrier and not an AI/software device. Therefore, the questions related to AI/software performance acceptance criteria, test sets, ground truth, expert opinions, and training sets are not applicable to this document.

The document discusses regulatory aspects of a Class II medical device, including:

• Trade/Device Name: Dental Barrier and Sleeves
• Regulation Number/Name: 21 CFR 878.4370, Surgical Drape And Drape Accessories
• Regulatory Class: Class II
• Product Code: PEM, PUI
• Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.

Since the device is a physical product and not an AI or software-based system, the acceptance criteria would relate to its physical properties, material safety, effectiveness as a barrier, and manufacturing quality, rather than algorithms or data performance. Such tests would typically involve:

• Material Biocompatibility: Testing to ensure the materials are not toxic or irritating when in contact with patients or users.
• Barrier Integrity/Effectiveness: Physical testing to confirm its ability to prevent the passage of fluids, microorganisms, or other contaminants.
• Physical Properties: Tensile strength, tear resistance, and dimensions to ensure it performs as intended under typical dental use conditions.
• Sterility (if applicable, though this device is noted as non-sterile): If it were a sterile barrier, testing would confirm the absence of viable microorganisms.
• Shelf Life: Stability testing to ensure the product remains effective and safe over its intended storage period.
• Manufacturing Quality Control: Adherence to Good Manufacturing Practices (GMP) to ensure consistent quality.

None of this information is detailed in the provided FDA clearance letter, as the letter primarily serves to confirm substantial equivalence to a predicate device and outlines regulatory obligations, not to present detailed study results for a non-AI/software device.

Ask a specific question about this device

The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical For use in infection control practices to reduce the potential exposure to blood and body fluids.This is a single use, disposable device(s), provided non-sterile.

The Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

For all performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the sample size used was 32 units per lot, across 3 non-consecutive lots.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the document is a 510(k) submission to the US FDA from a Chinese applicant (Wellmed Dental Medical Supply Co., Ltd. in Shenzhen, China), suggesting the tests were likely conducted by or for the manufacturer in China or by a certified lab for regulatory submission purposes. These are non-clinical (laboratory) tests performed specifically for regulatory approval.

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

This is a non-clinical, laboratory-based performance and biocompatibility study for a medical device (face mask). There is no "ground truth" in the clinical sense established by human experts like radiologists. The "ground truth" is determined by established scientific standards and test methods (e.g., ASTM, EN, ISO standards), with results measured by laboratory equipment and qualified personnel following those protocols. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically understood in AI/clinical studies does not apply here.

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

Not applicable. This is a non-clinical, laboratory-based performance and biocompatibility study. Adjudication methods are typically relevant for human-interpreted data, such as medical images or clinical diagnoses.

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 a non-clinical study for a medical face mask. It does not involve human readers, AI, or clinical effectiveness studies in this context.

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

Not applicable. This device is a physical medical product (a face mask), not a software algorithm.

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

The "ground truth" in this context is defined by the objective, reproducible measurements against established performance standards and specifications outlined in the referenced international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria for each test (e.g., "$\geq$ 98%," "< 6.0mmH2O/cm²") numerically define the acceptable performance.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

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

Ask a specific question about this device