(188 days)
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.
A disposable reflective marker sphere consists of two bonded half spheres and a screw part that is cut in the lower sphere. An adhesive combines the upper and lower half spheres. The raw sphere is covered with a defined retro-reflective foil.
The provided text describes a 510(k) summary for the "Disposable Reflective Marker Spheres" by BrainLAB AG. This document outlines the device's intended use, description, and states that it has been verified and validated. However, it does not detail specific acceptance criteria for performance, nor does it present the results of a study designed to prove the device meets such criteria with quantitative metrics.
The document focuses on substantial equivalence to a predicate device (Cranial Image Guided Surgery System K082060) rather than a direct performance study against a predefined set of acceptance criteria for the "Disposable Reflective Marker Spheres" themselves.
Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. The document mentions "essential requirements" but does not define specific metrics or thresholds for acceptance. | The device has been "verified successfully" for: - Crucial physical properties (e.g., Impact resistance, homogeneous retroreflectivity, shelf life) - Sterile Packaging - Sterilization The document states "Objective evidence specifications conform with user needs and intended use has Objective onload that acture research, comparison with previously marketed devices and the results of a clinical evaluation." However, no specific performance data or numerical results are provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. The document mentions "comparison with previously marketed devices and the results of a clinical evaluation," but no details about the methods, sample sizes, or nature (retrospective/prospective) of these evaluations are provided for the "Disposable Reflective Marker Spheres."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The document focuses on physical properties and claims of substantial equivalence rather than a diagnostic performance study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical marker sphere, not an AI or diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical marker sphere.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device would likely be adherence to engineering specifications and performance in tracking systems, rather than a clinical ground truth. The document alludes to "specifications conform[ing] with user needs and intended use."
8. The sample size for the training set
- Not applicable. This device is a physical marker sphere, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of missing information:
The provided document is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to a predicate device. It primarily lists verification and validation activities at a high level. It does not provide detailed performance data, specific quantitative acceptance criteria, study methodologies (like sample sizes, expert involvement, or adjudication methods), or the results of comparative effectiveness studies that would be typically found for diagnostic AI devices. The verification activities mentioned ("Impact resistance, homogenous retroreflectivity, shelf life," "Sterile Packaging," "Sterilization") imply that internal testing was conducted against company specifications, but these specifications and their results are not detailed in this summary.
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KI00038
JUL 1 4 2010
510 (k) Summary Disposable Reflective Marker Spheres
Manufacturer:
BrainLAB AG Address: Kapellenstrasse 12 Germany Phone:
85622 Feldkirchen +49 89 99 15 68 0 +49 89 99 15 68 33 Fax: Mr. Alexander Schwiersch Mar. 09, 2010
Summary Date:
Contact Person:
Device Name:
| Trade name: | Disposable Reflective Marker Spheres |
|---|---|
| Common/Classification Name: | Disposable Reflective Marker Spheres |
| Regulation number: | 21 CFR 882.4560 |
| Product codes: | HAW, OLO |
Predicate Device:
Cranial Image Guided Surgery System K082060
Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II
This submission does not change the indications for use for the predicate devices.
1. Intended Use:
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
2. Device Description:
A disposable reflective marker sphere consists of two bonded half spheres and a screw part that is cut in the lower sphere. An adhesive combines the upper and lower half spheres. The raw sphere is covered with a defined retro-reflective foil.
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3. Verification:
To ensure that all specifications of the device have been implemented correctly, following essential requirements have been verified successfully:
-
Crucial physical properties of the device (e.g. Impact resistance, homogenous retroreflectivity, shelf life)
-
Sterile Packaging
-
Sterilization
4. Validation:
- Validation:
Objective evidence specifications conform with user needs and intended use has Objective onload that acture research, comparison with previously marketed devices and the results of a clinical evaluation.
5. Substantial equivalence:
The Disposable Reflective Marker Spheres have been verified and validated according to BrainLAB's procedures for product design and development. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Cranial Image Guided Surgery System (K082060).
Image /page/1/Picture/9 description: The image shows a fraction of 2/2 over the letter P and the number 3. The fraction is written in a handwritten style, with the numerator and denominator stacked on top of each other. The letter P and the number 3 are written below the fraction, with a horizontal line separating them.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three overlapping figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BrainLAB AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 85622 Feldkirchen, Gemany
JUL 1 4 2010
Re: K100038
Trade/Device Name: Disposable Reflective Marker Spheres Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: July 02, 2010 Received: July 08, 2010
Dear Mr. Schwiersch:
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. 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.
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
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Page 2 - Mr. Alexander Schwiersch
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark M. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
长100538 510(k) Number (if known):
Device Name: Disposable Reflective Marker Spheres
Indications For Use:
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.
Mark M. Melson
(Division Sign-Off) (Division Sign-Only
Division of Surgical, Orthopedic, Division of Survices
510(k) Number ..
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).