(35 days)
The Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus.
The Synthes Proximal Humeral Nail is an intramedullary rod that features a distal taper design. It is 150 mm in length and has holes in both the proximal and distal sections that accept locking screws.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Synthes Proximal Humeral Nail. This kind of document typically grants market clearance based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials with acceptance criteria and statistical analysis as would be found for a novel, high-risk device.
Therefore, the information required to populate the requested table and answer the study-related questions is not explicitly present within the provided text.
Here's a breakdown of what can be inferred or stated based on the document's nature:
1. A table of acceptance criteria and the reported device performance
- Not explicitly stated in the provided text. For a 510(k) clearance, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device, usually through mechanical testing, material characterization, and often a review of the predicate's clinical history. Detailed performance metrics with acceptance thresholds (e.g., specific fracture healing rates, complication rates, or functional outcomes) are generally not required to be submitted in the summary for a Class II device like this.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated. Clinical test sets with human subjects are not typically required for 510(k) submissions for devices like intramedullary nails, especially if they are substantially equivalent to existing devices. If testing were conducted, it would likely be mechanical bench testing.
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 based on the provided text. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable based on the provided text. No adjudication method for a clinical test set is mentioned.
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
- No such study was mentioned or implied. This device is a physical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical "ground truth." For substantial equivalence, the "ground truth" would relate to demonstrating the device's material properties, mechanical strength, and design characteristics are comparable to the predicate device, often through engineering analysis and bench testing.
8. The sample size for the training set
- Not applicable. No machine learning or AI training set is relevant for this device clearance.
9. How the ground truth for the training set was established
- Not applicable. No machine learning or AI training set is relevant for this device clearance.
Summary based on the document:
The provided text is a 510(k) clearance letter for the Synthes Proximal Humeral Nail. This clearance is based on the device demonstrating substantial equivalence to existing predicate devices (Synthes (USA) Unreamed Humeral Nail; Acumed Polarus Proximal Humeral Fixation Rod).
The core "study" for a 510(k) typically involves:
- Comparison of technological characteristics: Showing that the new device has "the same technological characteristics as the predicate device" or "different technological characteristics from the predicate device and the information submitted demonstrates that the device is substantially equivalent to the predicate device" (often through bench testing and engineering analysis).
- Material composition: Reporting the material (Ti-6Al-7Nb) and demonstrating its biocompatibility and mechanical properties.
- Indications for Use: Demonstrating the new device has the same or similar indications for use as the predicate (fractures of the proximal humerus).
The document does not contain details about specific clinical studies with acceptance criteria or performance data in the way you would expect for a novel device requiring pre-market approval (PMA) or a device leveraging AI/imaging.
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OCT = 6 2000
3.0 Summary of Safety and Effectiveness Information
SPONSOR:
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Thomas M. Maguire
Synthes Proximal Humeral Nail DEVICE NAME:
Class II, Section 888.3020 - Intramedullary fixation rod. CLASSIFICATION:
Synthes (USA) Unreamed Humeral Nail; Acumed Polarus Proximal PREDICATE DEVICE: Humeral Fixation Rod
The Synthes Proximal Humeral Nail is an intramedullary rod that features a DEVICE DESCRIPTION: distal taper design. It is 150 mm in length and has holes in both the proximal and distal sections that accept locking screws.
INTENDED USE:
The Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus.
MATERIAL:
Ti-6Al-7Nb
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 6 2000
Mr. Thomas M. Maguire Project Leader, Regulatory Affairs Synthes (USA) P.O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301
Re: K002729
Trade Name: Synthes Proximal Humeral Nail Regulatory Class: II Product Code: JDS Dated: August 31, 2000 Received: September 1, 2000
Dear Mr. Maguire:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 910(x) from the materially equivalent (for the indisations for use, 1076, the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to device Amendments, or to devices that have been reclassified in may enactifield date of the Medical Dorted Frances of the Rederal Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general control provisions of the Act. "The general therefore, market the device, subject to annual registration, listing of devices, control provisions of the rice increase requence misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see asono) and additional controls. Existing major regulations (Fremarket Apploval), it may of success of Federal Regulations, Title 21, Parts 800 to 895. allecting your ac rive sant determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Manufacturing Places: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drug result in regulatory action. In addition, FDA may publish comply with the GMT regaraters in your device in the Federal Register. Please note: this response to your premarks betification 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and w you would of substantial equivalence of your device to a legally marketed nothleate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 – Mr. Thomas M. Maguire
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,
Mark N. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
Page of
510(k) Number (if known):
Synthes (USA) Proximal Humeral Nail Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications/Contraindications: The Synthes Proximal Humeral Nail is indicated for use in fractures of the proximal humerus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
Synthes (USA) Proximal Humeral Nail 510(k)
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.