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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.

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The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.

The body of the device is constructed of a polyurethane ester foam. A grit sheet is laminated to the top surface of the foam, and a pressure sensitive adhesive and release liner laminated to the base of the pad. An X-Ray detectable rod is placed between the pressure sensitive adhesive and the foam. The device is available in three sizes. Each pad is individually wrapped and sterilized for use. Sterilization will be by Gamma Ray or ETO and will be conducted and certified by a contract sterilization firm.

This document is a 510(k) summary for a medical device (electrosurgical tip protector/cleaner) from 1997. It describes the device, its intended use, and its technological characteristics, primarily comparing it to predicate devices to establish substantial equivalence.

Based on the provided text, there is no acceptance criteria or a study proving the device meets acceptance criteria in the way typically understood for modern AI/ML medical devices. This document predates the widespread use of such devices and the specific regulatory guidance around their performance evaluation. Instead, the submission relies on establishing "substantial equivalence" to existing, legally marketed predicate devices.

Therefore, most of the requested fields cannot be populated as there were no explicit performance studies or acceptance criteria defined in this submission as would be expected for a contemporary AI device.

Here's an attempt to address your request based only on the provided text, noting where information is absent:

Acceptance Criteria and Device Performance

For this 1997 510(k) submission, the "acceptance criterion" is implicitly demonstrating substantial equivalence to predicate devices. There are no specific quantitative performance metrics defined for this type of electrosurgical tip cleaner in the document.

• Intended Use
• Technological Characteristics (materials, design, abrasive surface) | The "Cygnus Electrosurgical Tip Protector" is stated to have the "same intended use" as predicate devices and "similar devices products currently cleared for marketing."
  The "composition and technological characteristics" are stated to be "the same as those for the predicate devices."
  Descriptive performance information is stated to show "that the materials of which the Cygnus product is made, is nearly identical to those of similar products currently on the market."
  The #60 Aluminum Oxide Impregnated Vinyl Grit Sheet abrasive surface is stated to have "proven to be effective" for over fifteen years in existing products. |

Detailed Study Information (Based on provided text):

Since this is a 510(k) submission for a non-AI/ML device based on substantial equivalence, the following sections either do not apply or the information is not present in the provided text.

1. Sample size used for the test set and the data provenance: Not applicable. There was no specific "test set" for performance evaluation in the context of an AI/ML device. Substantial equivalence was based on direct comparison of characteristics and known performance of similar materials.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this context.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission was the established safety and effectiveness of the predicate devices and the known properties of the materials used.
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of Approach in the Document:

The 510(k) submission relies on the "510(k) Substantial Equivalence Decision-Making Process." The argument for substantial equivalence is based on:

• Identical Intended Use: The device is for cleaning electrosurgical instrument tips, which is the same as predicate devices.
• Similar Technological Characteristics: The materials (polyurethane ester foam, aluminum oxide grit sheet, adhesive, X-ray detectable rod) used are either the same as or nearly identical to those in predicate and currently marketed devices.
• Known Efficacy of Materials: The abrasive material (#60 Aluminum Oxide Impregnated Vinyl Grit Sheet) has a proven history of effectiveness for over fifteen years.
• Manufacturing and Sterilization: These processes are consistent with established medical device practices.

The submission is essentially a comparison report rather than a performance study with defined acceptance criteria and human-involved evaluations for an AI solution.

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