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The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.

The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.

The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.

The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.

The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).

The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )

The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.

The Adeor Meridian™ Cranial Perforator is a sterile, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery. Its primary function is to automatically release and stop perforating once a specific cranial bone thickness is reached, preventing plunging into underlying tissue.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Meridian™ Cranial Perforator are primarily centered around its ability to automatically release and stop perforation at specified bone thicknesses, and its general mechanical functionality.

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

The document mentions that "Samples of each model were used to drill holes in wood and animal bone." It also states "On animal cadavers (pig head and calf shoulder) the release mechanism worked reliable and a clear bone pad has been formed..."

• Test Set Sample Size: The exact number of "samples of each model" is not specified. For the animal cadaver testing, it refers to "animal cadavers (pig head and calf shoulder)," implying at least one of each, but the total number of perforators tested on them is not given.
• Data Provenance: The animal cadaver testing used biological material (pig head and calf shoulder) which would be considered an in vitro/ex vivo study environment. The country of origin for this testing is not explicitly stated in the provided text. The company is based in Germany. The sterilization validation refers to international standards recognized by FDA.

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

No explicit mention of experts establishing ground truth for the mechanical performance testing is provided in the document. The performance bench testing appears to be objective measurements/observations rather than subjective expert assessments requiring a "ground truth" establishment in the traditional sense of clinical studies (e.g., for diagnostic accuracy). The "satisfactory" remarks and observations like "no friction," "no skidding," "firm axial rotation," and "plain and even surface" would likely be criteria directly observed and measured/assessed by the testing personnel (e.g., engineers, technicians).

4. Adjudication Method for the Test Set

Not applicable. There is no indication of subjective assessments by multiple individuals requiring an adjudication method. The performance bench testing focuses on objective, measurable mechanical functionality and observation of device behavior.

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

No. This type of study is not relevant for the evaluation of a mechanical surgical device like a cranial perforator. MRMC studies are typically used to assess diagnostic accuracy or the impact of AI assistance on human interpretation of medical images.

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

Not applicable. The device is a mechanical surgical tool, not an AI algorithm. Its performance is inherent to its design and mechanical function, with human operation being an integral part of its use.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is the objective physical behavior of the device (e.g., whether it stops perforating at the correct depth, whether it exhibits friction, skidding, or wobbling, and the quality of the cut). This is established through direct observation and measurement during the bench testing on wood, animal bone, and animal cadavers.

For sterility, the ground truth is established by scientific validation against recognized international standards (ISO 11137 series) that define a Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

Not applicable. The Meridian™ Cranial Perforator is a mechanical device, not a machine learning or AI model 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 this mechanical device.

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