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The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction.

The Arthronet BLACKLINE Arthroscopic Blades are manufactured by Arthronet GmbH & Co. KG (formerly Imtec Medinzentechnik). The Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first).

This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System.

Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. These materials are essentially equivalent to those of predicate devices. Configurations and sizes are typical of predicate devices and indicated in catalog labeling.

Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Autoclave sterilization parameters are equivalent to predicate products noted and directions for use, cleaning and sterilization are contained in product labeling.

Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132 degrees C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products.

Arthronet BLACKLINE Arthroscopic Blades are limited use devices. Blades are clearly labeled for use a maximum of three (3) uses. The blade assemblies can be discarded after three uses. Product usage and cautions related to potential damage to the blade assemblies as a result of handling or cleaning are clearly defined in product labeling. All product usage is based upon design data developed during product design, simulated use verification testing, and is also based upon seven years of clinical product experience in the worldwide market.

The provided text does not contain detailed acceptance criteria for the device beyond its intended use and material similarity to predicate devices. It also states the device has been sold worldwide for eight years and meets international safety requirements, with a complete risk analysis filed. However, it does not describe a "study" in the sense of a clinical trial or performance evaluation with specific numerical metrics and results.

Here's an analysis of what information is available based on your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information Regarding Acceptance Criteria and Performance:

The document focuses on establishing substantial equivalence to predicate devices, material descriptions, and intended use rather than presenting a performance study with detailed acceptance criteria and quantitative results. There are no specific numerical thresholds for performance metrics (e.g., cutting force, wear resistance, sharpness after sterilization cycles) that would constitute "acceptance criteria" in a typical device performance study.

Regarding the "Study" Proving Acceptance:

The document refers to "simulated use testing on file with the manufacturer" for cleaning and sterilization, and "design data developed during product design, simulated use verification testing, and ... seven years of clinical product experience in the worldwide market" for product usage and cautions. However, no details about these "studies" are provided in the text.

Here's an assessment based on the available information:

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

• Test Set Sample Size: Not specified. The phrase "simulated use testing on file with the manufacturer" and "seven years of clinical product experience in the worldwide market" are mentioned, but no specifics on the number of devices or cases used for testing the current device for its regulatory submission are provided.
• Data Provenance: "Worldwide market" and "on file with the manufacturer" (likely Germany, where Arthronet GmbH & Co. KG is located) are mentioned for clinical experience and simulated use testing, respectively. This suggests a retrospective compilation of experience and internal prospective testing.

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

• Not applicable/Not specified. The document does not describe a study involving expert assessment or ground truth establishment in the context of human interpretation or diagnostic accuracy. The device is a surgical tool, and its "performance" would relate to its mechanical function, material properties, and sterility.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. Given the nature of the device (arthroscopic blade), the concept of "adjudication" for a test set (which usually applies to diagnostic interpretations) is not relevant here.

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

• No. This type of study (MRMC) is typically for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. The Arthronet BLACKLINE Arthroscopic Blades are surgical tools, not diagnostic devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical surgical tool and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• For Cleaning/Sterilization: The text states "simulated use testing on file with the manufacturer" was used, and that "cleaning and sterilization criteria are recommendations only" with hospitals needing to use their own validated processes. This suggests internal engineering/bench testing to establish initial parameters, but not a "ground truth" derived from patient outcomes or pathology.
• For Product Usage (Limited Use): Based on "design data developed during product design, simulated use verification testing, and... seven years of clinical product experience." Again, this points to engineering/bench testing and real-world experience/outcomes surveillance rather than a specific "ground truth" established for a defined test set.

8. The Sample Size for the Training Set:

• Not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. (As above, no training set for an algorithm).

In summary, the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing predicate devices based on materials, intended use, and general design principles for a simple, non-AI surgical instrument. It references internal testing and market experience but does not detail a formal performance study with specific acceptance criteria and results as typically found for more complex or novel devices.

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