(59 days)
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes DHS Helix System is a plate and screw system. The DHS plate is a straight with an angled barrel portion that accepts a helix screw. The barrel angles are available in various degrees and the plates are available in multiple lengths. The plate accepts the DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
This document describes a medical device submission (K981757) for the Synthes (USA) DHS Helix System, a bone plate and screw system. It is a 510(k) summary, which is a premarket notification demonstrating that a device is substantially equivalent to a legally marketed predicate device.
Key takeaway: This document is a 510(k) submission for a surgical implant (bone plate and screw system). It does not contain information about acceptance criteria or a study demonstrating the device meets those criteria, as typically found for AI/software devices. The approval is based on "substantial equivalence" to a predicate device, not on specific performance metrics established through an independent clinical study for this particular device.
Therefore, I cannot provide the requested information for an AI/software device based on this document. The provided text is for a physical medical device (bone plate and screw system) and addresses regulatory clearance based on substantial equivalence rather than performance metrics typically associated with AI/software studies.
However, I will extract what information is present in the document that might conceptually align with your request, even if it's not a direct match for an AI study.
Based on the provided document, which is a 510(k) summary for a physical medical device (bone plate and screw system), the requested information pertaining to acceptance criteria and a study proving a device (typically referring to an AI/software device) meets those criteria cannot be fully extracted or is not applicable in the context of this submission type.
Here's an explanation of why and what information can be gleaned, reinterpreting your request for a physical medical device submission:
- 510(k) Submissions: These are primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel technology through a dedicated clinical study from scratch. The performance of the predicate device is generally accepted.
- "Device" in this context: Refers to the physical Synthes DHS Helix System (bone plate and screw).
- No AI/Software Component: There is no indication of any AI or software component in this device, making most of your questions about AI study specifics irrelevant.
Attempted Interpretation of Request in the Context of a Physical Medical Device (510(k) Submission):
Given the limitations, here's how some of your questions might be addressed, acknowledging that direct answers for AI performance are not possible from this document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Conceptual for 510(k) & Mechanical Device) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Material: Stainless Steel | The device is made of Stainless Steel, matching a commonly accepted material for such implants and likely the predicate device. |
| Intended Use: Treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. | The intended use is identical to or sufficiently similar to the predicate device, implying that its performance for treating these specified fractures is within accepted medical practice for this type of implant. The specific performance metrics (e.g., bone healing rates, complication rates) of this exact device are not presented, but rather the claim is that it functions like the predicate device for these indications. Mechanical testing would have been performed to ensure structural integrity and equivalence to the predicate, though specific test results and acceptance criteria are not in this summary. |
| Design Characteristics: Plate and screw system, straight plate with angled barrel and helix screw, various barrel angles/plate lengths, accepts DHS Helix Screw (75-130mm) and 4.5mm cortex screws. | The design features are described as fulfilling the requirements for its intended use and are compared to the predicate device (Synthes LC-DHS) for substantial equivalence. The implication is that these design parameters ensure the device performs similarly to the predicate in supporting bone fractures. |
| Classification: Class II, 21 CFR 888.3030 and 888.3040 | The device falls under established classifications for bone plates and screws. This implies it meets the general controls and potentially special controls (though not detailed here) for devices of this type, ensuring a baseline of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a 510(k) summary for a physical device. This type of document generally relies on non-clinical (e.g., mechanical) testing and comparison to an existing device, not a "test set" of patient data in the way an AI study would. There is no mention of patient data (retrospective or prospective) for this specific device in this summary document.
- Data Provenance: Not mentioned, as it's not a clinical data study.
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. There is no "ground truth" derived from expert consensus on medical images or patient data described in this 510(k) summary. The "ground truth" for a physical implant's safety and effectiveness is largely established through regulatory classifications, known material properties, mechanical testing, and the clinical history of substantially equivalent predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication in the context of an AI study 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
- Not applicable. This device is a physical bone plate and screw system, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a physical implant, the "ground truth" for its safety and effectiveness is derived from a combination of:
- Regulatory Standards: Compliance with established FDA regulations (e.g., 21 CFR 888.3030 and 888.3040 for Class II devices).
- Material Science: Proven biocompatibility and mechanical properties of Stainless Steel.
- Mechanical Testing: (Implied, but not detailed in this summary) Strength, fatigue, and other biomechanical tests to ensure the device can withstand physiological loads.
- Predicate Device History: The long-standing safe and effective use of the predicate device (Synthes LC-DHS) for the stated indications.
8. The sample size for the training set
- Not applicable. No training set, as it's not an AI/software device.
9. How the ground truth for the training set was established
- Not applicable. No training set.
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Summary of Safety and Effectiveness Information [510(K) Summary]
| SPONSOR | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Angela Silvestri |
|---|---|
| COMMON OR USUALNAME: | Bone Plate and Bone Screw |
| DEVICECLASSIFICATION | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes LC-DHS |
| DESCRIPTION: | Synthes DHS Helix System is a plate and screw system. TheDHS plate is a straight with an angled barrel portion that acceptsa helix screw. The barrel angles are available in various degreesand the plates are available in multiple lengths. The plateaccepts the DHS Helix Screw (lengths ranging from 75 mm to130 mm) and 4.5 mm cortex screws. |
| INTENDED USE: | Synthes DHS Helix System is intended to treat stable and unstableintertrochanteric, subtrochanteric and basilar neck fractures inwhich a stable medial buttress can be reconstructed. |
| MATERIAL: | Stainless Steel |
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Ms. Angela J. Silvestri ·Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K981757 Synthes (USA) DHS Helix System Regulatory Class: II Product Code: JDO Dated: May 18, 1998 Received: May 19, 1998
Dear Ms. Silvestri:
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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 requlations.
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Page 2 - Ms. Angela J. Silvestri
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., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K981757 |
| Device Name: | Synthes (USA) DHS Helix System |
| Indications for use: |
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Sign-Off
| K981757 | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
| DHS Helix System Synthes (USA) | |
|---|---|
| -------------------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | CONFIDENTIAL |
|---|---|
| --------------- | -------------- |
04
§ 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.