(54 days)
This device is intended to be used to obtain bone from the iliac crest or other skeletal sites. It is indicated in conditions requiring the examination of bone, e.g., metabolic bone disease, metastatic disease to the bone, osteoporosis, and osteomalacia, or in conditions requiring the use of bone graft, e.g., nonunion or delayed union of fractures, bone defects, and fusions.
Bone Graft Harvester
This document is a 510(k) clearance letter from the FDA for a Bone Graft Harvester device, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
The document indicates that the device is "substantially equivalent" to predicate devices, which is the basis for its market clearance. This substantial equivalence is a regulatory finding, not a clinical study demonstrating performance against specific numerical acceptance criteria.
Here's a breakdown of what can be inferred or what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion for 510(k) clearance is "substantial equivalence" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and performance (safety and effectiveness) without raising new questions of safety or effectiveness.
- Reported Device Performance: Not reported in terms terms of clinical outcomes or performance metrics. The letter confirms that based on the provided information, the device is considered substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a performance study with a test set.
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. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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 is a clearance for a physical medical device (Bone Graft Harvester), not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is described.
8. The sample size for the training set
- Not applicable. This document is not describing a machine learning or AI device with a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a regulatory clearance letter based on substantial equivalence, not a scientific publication detailing a study about a device's performance against specific, quantifiable acceptance criteria.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of what appears to be an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1997
Martin A. Yahiro, M.D. ·10605 Steamboat Landing Columbia, Maryland 21044
K973560 Re: Bone Graft Harvester Regulatory Class: I Product Code: HWE Dated: September 19, 1997 Received: September 19, 1997
Dear Dr. Yahiro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Martin A. Yahiro, M.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Document Number : K973560 Bone Graft Harvester Device Name: Sponsor : Martin A. Yahiro, M.D.
INDICATIONS FOR USE STATEMENT
This device is intended to be used to obtain bone from the iliac crest or other skeletal sites. It is indicated in conditions requiring the examination of bone, e.g., metabolic bone disease, metastatic disease to the bone, osteoporosis, and osteomalacia, or in conditions requiring the use of bone graft, e.g., nonunion or delayed union of fractures, bone defects, and fusions.
Prescription Use
(Per 21 CFR 801.109)
Dioellf
Division of General Restorative De 510(k) Number
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.