Search Results

The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time.

The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6) months.

The SklarLite" Rigid Sterilization Container System consists of a family of rigid, re-usable, stackable, sealed containers that provide an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. Containers can be fitted with safety lids, protecting filters during storage and/or transport. The system consists of the following components:

• Container bottoms (both perforated and non-perforated versions) .
• Container lids (both perforated and non-perforated_versions)_ .
• Container baskets .
• Container labels .
• Disposable filters .

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated. Containers are offered in six colors. Filter media and sterilization indicator cards should be used in conjunction with the containers. Containers are protected by disposable plastic security seals.

The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. The containers are validated for sterilization of enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document implies that the validation testing was conducted on samples of the SklarLite™ Rigid Sterilization Container System, applying various configurations (e.g., container sizes, lumen sizes, load weights, stacking configurations). Specific numeric sample sizes for each test are not provided.
   • Data Provenance: The study was conducted by Sklar Instruments for a 510(k) pre-market notification to the FDA. This indicates the testing was performed specifically for regulatory submission, likely at the manufacturer's facilities or a contracted testing lab. The data is prospective as it was gathered to prove the device's performance prior to market availability. Country of origin is the United States (Sklar Instruments is in West Chester, PA, and the FDA is in Silver Spring, MD).

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

   • This is a performance validation study for a medical device (sterilization container), not a diagnostic algorithm or image analysis. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation of data (e.g., radiologists for images) is not applicable.
   • Instead, ground truth is established through validated scientific methods and instrumentation (e.g., biological indicators, sterility testing, physical measurements of lumens and load, specific cycle parameters of sterilizers). The "truth" is whether sterilization was achieved and maintained, which is objectively measurable using established microbiological and engineering standards. The expertise would lie with microbiologists, sterilization engineers, and quality assurance personnel conducting the tests and interpreting the results according to AAMI/ANSI standards.

3. Adjudication method for the test set:

   • Not applicable in the conventional sense of adjudication for intellectual tasks. Device performance testing adheres to standardized protocols and acceptance criteria (e.g., AAMI/ANSI ST77:2006). Results are typically binary (pass/fail) based on objective measurements (e.g., growth or no growth of test organisms, maintenance of mechanical integrity). Any deviations would likely be handled through standard quality control and technical review processes, rather than a panel of adjudicators.

4. 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 is not applicable. The device is a physical sterilization container, not an AI or diagnostic tool that involves human readers interpreting output.

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

   • Not applicable. The device is a physical product, not an algorithm. The "standalone performance" is its ability to meet the sterilization and sterility maintenance criteria independently.

6. The type of ground truth used:

   • Scientific and Objective Measurements: The ground truth for this device is based on objective, measurable scientific criteria for sterilization effectiveness and sterility maintenance. This includes:
     • Biological Indicators: Confirmation of complete kill of highly-resistant microorganisms (e.g., Geobacillus stearothermophilus spores) within the most challenging locations (lumens, inside containers).
     • Physical and Chemical Indicators: Monitoring of steam penetration, temperature, and duration during sterilization cycles.
     • Microbiological Barrier Integrity Testing: Demonstrating that the container prevents microbial ingress over the stated sterility maintenance period.
     • Mechanical Integrity Testing: Ensuring the container and its components withstand repeated sterilization cycles and handling.
     • Dimensional Measurements: Verifying lumen internal diameters and lengths as well as container dimensions.
     • Weight Measurements: Verifying load limits.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/machine learning device that requires a training set. The development of the container would involve design, prototyping, and iterative testing, but not in the sense of a data "training set" for an algorithm.

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

   • Not applicable, as there is no training set for this type of device. The design and engineering of the sterilization container would rely on established principles of sterile processing, material science, and manufacturing standards.

Ask a specific question about this device

The Sklar Surgical Gown is a single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates.

The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

The Sklar Surgical Gown is provided as sterile and non-sterile.

Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.

The Sklar Surgical Gown is an open back gown manufactured from a non-woven fabric. The non-woven fabric is a polypropylene spunbond meltblown and the fibers are mechanically bonded together. The Surgical Gown comes in various sizes without any areas of reinforcement. The Surgical Gowns are supplied sterile and non-sterile, for single use only.

The provided text describes a 510(k) premarket notification for the "Sklar Surgical Gown." This document focuses on the regulatory submission and approval process for a medical device (a surgical gown), rather than a study evaluating the performance of an AI/ML powered device.

Therefore, the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.

The text includes:

• Device Name: Sklar Surgical Gown
• Classification: Class II, 21 CFR 878.4040, Product Code: FYA (Surgical Apparel)
• Predicate Device: Welmed Inc. Surgical Gowns - K070431
• Device Description: Open back gown from non-woven fabric (polypropylene spunbond meltblown), various sizes, no reinforcement, supplied sterile and non-sterile for single use.
• Indications for Use: "A single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates."
• Regulatory Outcome: Found substantially equivalent to a predicate device.

To answer your request, I would need a document detailing a study specifically designed to evaluate an AI/ML device against acceptance criteria, including performance metrics, data sets, expert review, and statistical analyses.

Ask a specific question about this device