Search Results

The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)

The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:

• Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
• b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
  The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
  The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.

Based on the provided text, the device in question is "Sterilization Pouches and Reels" (K242898), which is a medical device intended for enclosing other medical devices for sterilization. There is no mention of "AI" or "human readers" in the context of this device. The document describes a traditional 510(k) submission, primarily focusing on non-clinical performance testing and comparison to a predicate device.

Therefore, many of the requested points in your prompt that relate to AI/algorithm performance, human readers, ground truth establishment for complex data, and MRMC studies are not applicable to the information provided.

However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical performance testing described.

Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted to demonstrate the safety and effectiveness of the Sterilization Pouches and Reels. The acceptance criteria are implicitly met if the "Pass" status is achieved for each test, indicating conformity to the referenced ISO or ASTM standards.

Information Not Applicable or Not Found in the Provided Text:

2. Sample size used for the test set and the data provenance: The document does not specify the sample sizes (number of pouches/reels) used for the non-clinical performance and biocompatibility tests. It also does not specify the provenance (country of origin, retrospective/prospective) of any "data" beyond general testing. The tests are laboratory-based performance tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is adherence to established engineering and material science standards (e.g., ISO, ASTM), rather than expert consensus on medical image interpretation.
4. Adjudication method: Not applicable, as there's no expert interpretation involved in the performance testing described.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
7. The type of ground truth used: For this device, the "ground truth" is adherence to established physical, chemical, and biological performance standards (e.g., seal strength, sterility barrier, chemical indicator color change, biocompatibility). It is determined by the results of specific standardized laboratory tests, not by expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.
8. The sample size for the training set: Not applicable. There is no AI/machine learning component, so no training set is used.
9. How the ground truth for the training set was established: Not applicable. There is no AI/machine learning component, so no training set or its ground truth establishment is mentioned.

Summary of Applicable Information:

The study proving the device meets its acceptance criteria is primarily based on non-clinical performance testing as outlined by various international and national standards (ASTM, ISO, DIN). The document explicitly states: "Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards..."

The core method of verification is demonstrating "Pass" for each of the listed tests according to the requirements of the specified standards. This type of device relies on engineering and material science validation rather than clinical trials involving human subjects or AI performance metrics.

Ask a specific question about this device

The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile and sterile.

The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.59.5cm, 14.59.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.

The provided document is a 510(k) Pre-market Notification for a Disposable Surgical Mask, primarily focusing on proving substantial equivalence to a predicate device based on non-clinical performance standards. It explicitly states, "No clinical study is included in this submission." Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets acceptance criteria using clinical or AI-driven performance metrics.

The document outlines acceptance criteria for non-clinical tests (e.g., fluid resistance, particulate efficiency, bacterial filtration, differential pressure, flammability, biocompatibility) to demonstrate the proposed device performs as well as or better than the predicate surgical mask. However, these are physical and biological performance metrics for the mask itself, not measures of a complex device's performance in a clinical setting or where AI is involved.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what information is available related to performance:

Information NOT available in the provided document:

1. A table of acceptance criteria and the reported device performance related to a clinical or AI-driven study: The document presents a comparison table (page 5) of the proposed and predicate device's specifications and physical performance parameters, not clinical performance against acceptance criteria for a device involving AI or complex decision-making.
   • For example, it states "Fluid Resistance: Pass at 160 mmHg" as a characteristic, which is a physical test result, not a clinical outcome or AI performance metric.
2. Sample size used for the test set and data provenance: Not applicable as no clinical or AI test set is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable as no ground truth for a clinical or AI study is established.
4. Adjudication method for the test set: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission." (page 7)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as no AI/machine learning component is described.
9. How the ground truth for the training set was established: Not applicable.

Information related to "acceptance criteria" and "performance" that IS in the document, but for physical/biological mask properties:

The document lists performance measures for the physical characteristics of the surgical mask:

1. A table of acceptance criteria and the reported device performance (for physical/biological properties):

Ask a specific question about this device

Ask a specific question about this device