(24 days)
Dissection tools are intended for cutting and shaping bone including spine and cranium.
The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems. The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system. Dissection Tools are sterilized, individually packaged, are for single use and disposable.
The provided text is a 510(k) Premarket Notification for "Dissection Tools" by The Anspach Effort, Inc. It describes a medical device, its intended use, and the performance testing conducted. However, it does not include detailed acceptance criteria or the specific study data that would allow a comprehensive answer to the requested questions regarding AI/ML device evaluation.
The device described is a physical surgical tool, not an AI/ML software device. Therefore, many of the questions related to AI/ML specific evaluation metrics, such as sample size for test sets and training sets, ground truth establishment for AI models, multi-reader multi-case studies, and human-in-the-loop performance, are not applicable to this submission.
Here's what can be extracted and what cannot based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document. The document states:
- "Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools."
- "These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards."
While it mentions that tests verified "established physical characteristics, functional requirements and performance standards," no specific quantitative acceptance criteria or corresponding device performance results are listed.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This question is relevant for AI/ML device validation, typically referring to a dataset of medical images or patient data. For this physical device, "test set" would refer to the number of units tested, but this information is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable/Not provided. "Ground truth" in this context typically refers to expert-labeled data for AI/ML models. For a physical device, testing its mechanical function would not involve "expert-established ground truth" in the same way.
4. Adjudication Method for the Test Set
Not applicable/Not provided. This is relevant for resolving discrepancies in expert labeling for AI/ML ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, not done. MRMC studies are used to evaluate the diagnostic accuracy of AI/ML systems, often comparing human readers with and without AI assistance. This device is a physical dissection tool, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, not applicable. A "standalone" study refers to the performance of an AI algorithm without human input. This is not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As described above, the concept of "ground truth" for AI/ML model training/testing does not apply here. The device went through "design verification" tests to ensure it met "design requirements" and "performance standards," which are forms of ground truth for mechanical devices.
8. The Sample Size for the Training Set
Not applicable/Not provided. This question is for AI/ML models.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This question is for AI/ML models.
In summary:
The provided document is a 510(k) for a physical medical device (dissection tools), not an AI/ML driven device. Therefore, the questions related to AI/ML specific evaluation methodologies are not addressed in this filing. The filing only states that "Design verification was conducted on the proposed design change of the locking mechanism...These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards." No specific acceptance criteria or quantitative performance data are detailed in the publicly available summary.
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The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools
DEC 1 6 2011
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | The Anspach Effort, Inc.4500 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|
| ----------- | ---------------------------------------------------------------------------------- |
- Official Correspondent Jeannette G. Dailey Regulatory Affairs Manager Tel. 561-494-3710 Fax. 561-625-9110 Email dailey.jeannette@synthes.com
Class II
Dissection Tools
(Compound Powered)
Date Prepared December 13, 2011
Device Name
..............................................................................................................................................................................
Classification Name
Device Classification
Predicate Devices
Neurological Devices Panel 21 CFR §882.4310 HBE
Drills, Burrs, Trephines & Accessories
eMax2 Plus System (Component to system) K080802
Minimal Access Spinal Attachment (MASA) System (Component to system) K042783
Device Description
The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The
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The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools
base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems.
The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system.
Indications for Use Dissection tools are intended for cutting and shaping bone including spine and cranium.
Dissection Tools are sterilized, individually packaged, are for single use and disposable.
Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors both electric and pneumatic, and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips.
Performance Testing
Technological
Characteristics
Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools.
These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards.
Conclusion
Based on the testing, risk analysis and comparison to the predicate devices, the Dissection Tools described in this submission perform as intended and raises no new safety or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
The Anspach Effort, Inc. c/o Ms. Jeanette G. Dailey Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, FL 33410
DEC 1 6 2011
Re: K113476
Trade/Device Name: Dissection Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, bores, trephines, and their accessories Regulatory Class: Class II Product Code: HBE Dated: November 18, 2011 Received: November 22, 2011
Dear Ms. Dailey:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Jeanette G. Dailey
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __K113476
Device Name:_Dissection Tools
Indications For Use:
Dissection tools are intended for cutting and shaping bone including spine and cranium.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
1000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of
K113476 510(k) Number _
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).