Search Results

The primary purpose of the device is to protect surgical instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.

The "Cygnus Instrument Protectors" liners and pouches are constructed with reticulated polyurethane ester foam. The material's open cell structure allows for the free flow of air, moisture and heat and is virtually free of particulate matter. The variety of sizes and shapes allows for greater flexibility in padding the instruments. Tray liners are available in precut sheets and rolls. uthe pouches are available in three sizes of single pouches and two sizes of multi pouch rolls. The pouches are formed by heat sealing the edges and seams. Each product is available in individual boxes as well as bulk case packaging. The products are shipped and marked as "non sterile" and "disposable". Each box is marked with a control lot number and universal bar code.

This device is for protecting surgical instruments during sterilization, storage, and transportation. The provided text is a 510(k) Summary from 1996, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of document does not typically contain detailed acceptance criteria and study data in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.

Therefore, many of the requested sections (e.g., sample size for test/training sets, experts for ground truth, MRMC study, ground truth type) are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with specific thresholds. Instead, it compares the technological characteristics of the "Cygnus Instrument Protectors" to those of predicate devices to establish substantial equivalence. The "performance" here relates to these physical characteristics.

Explanation of "Acceptance Criteria" (Implied): The document states: "The technological characteristics of the Cygrass Instrument Protectors are identical to the predicate devices, as well as a number of other manufacturers producing this type of product. The tensile streagth [sic] (30 lbs. psi.), elongution [sic] (200%), tour [sic] strength (4.0 lbs. psi), density ( 1.9 lb./cu. ft.) and porosity (50Pore per sa. in.) all define this product as being appropriate and consistent with the intended use of the product." This indicates that the reported performance values are considered "accepted" because they are "identical to the predicate devices" and "appropriate and consistent with the intended use."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document describes physical characteristics, not a clinical test set with a specific number of samples or patients. It refers to material properties.
• Data Provenance: Not specified. This information pertains to the material's inherent properties and manufacturing specifications rather than patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. The "ground truth" for the physical and material characteristics would be established through standard engineering and materials testing, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance assessments, not for verifying material properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI-assisted) on human reader performance, which is not relevant for a passive instrument protector in a 510(k) summary focused on material properties and substantial equivalence.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

• No, a standalone performance study was not done. This device is not an algorithm; it's a physical product.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering and material specifications (tensile strength, elongation, tear strength, density, porosity) and the established performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an AI algorithm 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 an algorithm, there is no ground truth established for it.

Ask a specific question about this device