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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K071931

p 1 c 1-
2

510(k) Summary Codman® Disposable Perforator

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

OCT 2 2 2007

Contact Person

Emily E Valerio Regulatory Affairs Specialist II Telephone Number: (508) 828-3038 Fax Number: (508) 828-2777

Name of Device

Proprietary Name:	Codman® Disposable Perforator
Common Name:	Disposable Perforator
Classification Name:	Powered compound cranial drills, burrs, trephines and their accessories

Device Classification

Powered compound cranial drills, burrs, trephines, and their accessories are Class II devices per 21 CFR § 882.4305 (84 HBF).

Statement of Substantial Equivalence

Codman Disposable Perforators are substantially equivalent to the Codman Disposable Perforator with Hudson End (K791101A) based on the device's similarity to the predicate device in intended use, materials, design, and principles of operations.

Indications for Use

Codman Disposable Perforators are intended to perforate the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Physical Description

{1}------------------------------------------------

K071931

Image /page/1/Picture/1 description: The image shows the numbers 2, 6, 1, and 11. The numbers are written in a simple, handwritten style. The numbers are arranged in a horizontal line, with the number 11 appearing below the number 1.

Device Testing

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.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Codman & Shurtleff, Inc. % Ms. Emily E. Valerio Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767 OCT 2 2 2007

Re: K071931

Trade/Device Name: Codman Disposable Perforators Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBF Dated: September 13, 2007 Received: September 14, 2007

Dear Ms. Valerio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Emily E. Valerio

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely

For Mark N. Melkerson Dep 0,2
10/19/95

Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K071931

P. i. o t' l

Indications for Use

510(k) Number (if known):

Device Name:

Codman Disposable Perforators

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P.C.M.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K07197

Regulation Number and Section

§ 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).