(101 days)
The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.
The provided 510(k) summary for the Codman® Disposable Perforator (K071931) is lacking the specific details required to fully address your request regarding acceptance criteria and the comprehensive study information.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
Paucity of Information: The document states "Substantial equivalence for this device is based upon comparison to predicate device characteristics and performance testing. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device." However, it does not provide any specific acceptance criteria values or detailed performance results from the device testing. It also does not describe a specific "study" in the sense of a clinical trial or a detailed lab study with statistical analysis, but rather refers to "performance testing."
Despite these limitations, I will attempt to answer your questions as best as possible with the available text.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria or reported performance metrics are not available. The document broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria not detailed in document | Meets or exceeds minimum qualification criteria for the predicate device. Automatically disengages once perforation is accomplished and pressure is removed. |
| Automatic disengagement capability | Designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "performance testing" but does not indicate the number of devices or subjects tested.
- Data Provenance: Not specified. It's highly likely to be lab-based testing rather than clinical data, given the nature of the device and the general tone of the 510(k) summary, but this is not explicitly stated. It would be retrospective in the sense that the testing was conducted on manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Specified. This device is a mechanical surgical tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data, typically refers to diagnostic or imaging devices. For a mechanical device like a perforator, "ground truth" for performance would be established through engineering specifications and objective measurements (e.g., disengagement force, drilling speed, material integrity), not expert consensus on interpretations. No experts are mentioned in relation to establishing ground truth for the performance testing.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers/experts, common in diagnostic studies. For objective performance testing of a mechanical device, such methods are not relevant or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is not applicable to a mechanical surgical perforator. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, for diagnostic tasks (e.g., radiologists reading images). This device is a tool, not an AI diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a mechanical perforator, not an algorithm or AI system. Its performance inherently involves a human operator.
7. The Type of Ground Truth Used
- Objective Engineering/Performance Specifications. For a device like a surgical perforator, the "ground truth" for determining performance would be against pre-defined engineering specifications and measurable physical properties. For example, the automatic disengagement mechanism would be tested to ensure it activates within a specified force or depth range, and materials would be tested for strength and sterility. The document implies this by stating "Device qualification criteria meet or exceed the minimum qualification criteria."
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
Conclusion:
The provided 510(k) summary for the Codman® Disposable Perforator (K071931) is primarily focused on demonstrating substantial equivalence to a predicate device through similarity in design, materials, and intended use, along with general "performance testing" that ensures it "meets or exceeds minimum qualification criteria." It does not contain the detailed quantitative data, specific study designs (like MRMC), or AI-related information that your questions are structured to elicit. This is typical for submissions concerning mechanical surgical instruments where the focus is on safety, performance against established engineering benchmarks, and equivalence to existing devices.
§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).