(27 days)
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes LCP Dynamic Helical Hip System is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. Synthes Helical blades, ranging in lengths from 135 mm to 150 mm are to be added to this system
The provided document is a 510(k) summary for the Synthes LCP® Dynamic Helical Hip System, Additional Helix Blades. This document focuses on the substantial equivalence of a medical device to a legally marketed predicate device, rather than providing details on a study proving the device meets specific acceptance criteria in terms of performance metrics.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be fully retrieved from this document. The 510(k) process primarily assesses whether a new device is as safe and effective as an already marketed device, often through engineering analysis and comparison of materials, design, and indications for use.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states that "Documentation is provided which demonstrates that the Synthes LCP Dynamic Helical Hip System, additional Helix Blades is substantially equivalent to other legally marketed Synthes devices." This implies that the 'acceptance criteria' are met by demonstrating similarity to the predicate device, not by achieving quantitative performance thresholds through a clinical study described here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. No clinical or performance study involving a "test set" is described in this 510(k) summary.
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 available. As no test set study is detailed, there's no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available.
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 available. This device is a surgical implant (hip system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not available.
8. The sample size for the training set
- Not available.
9. How the ground truth for the training set was established
- Not available.
Summary based on the provided document:
The 510(k) summary focuses on demonstrating that the "Synthes LCP® Dynamic Helical Hip System, Additional Helix Blades" is substantially equivalent to its predicate device, the "Synthes LCP® Dynamic Helical Hip System." The key elements for this determination are:
- Indications for Use: Both devices are intended "to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed."
- Material: Both are made of Stainless Steel.
- Description: The new device adds specific helical blade lengths (135mm to 150mm) to the existing plate and screw system.
The "study" in this context is the documentation provided to the FDA demonstrating this substantial equivalence, which primarily relies on engineering comparisons, material properties, and intended use, rather than a clinical performance study with defined acceptance criteria and performance metrics.
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NOV 1 6 2004
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- 510(k) Summary:
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes LCP® Dynamic Helical Hip System, Additional HelixBlades |
| Device Classification: | 21 CFR 888.3030 -- "Single/multiple component metallic bonefixation appliances and accessories" |
| Predicate Device: | Synthes LCP® Dynamic Helical Hip System |
| Description of Device: | Synthes LCP Dynamic Helical Hip System is a plate and screw systemthat consists of a straight plate with an angled barrel that accepts ahelical blade. Synthes Helical blades, ranging in lengths from 135mm to 150 mm are to be added to this system |
| Indications: | Synthes LCP® Dynamic Helical Hip System is intended to treat stableand unstable intertrochanteric, subtrochanteric and basilar neckfractures in which a stable medial buttress can be reconstructed. |
| Material: | Stainless Steel |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes LCPDynamic Helical Hip System, additional Helix Blades is substantiallyequivalent to other legally marketed Synthes devices. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-0800
Re: K042895
K042895
Device Name: Synthes (USA) LCP® Dynamic Helical Hip System (LCP DHHS), Additional Helix Blades Regulation Number: 21 CFR 888.3030 Regulation Number. 21 CFK 886.5050
Regulation Name: Single, multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 29, 2004 Received: November 1, 2004
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 910(x) premained in substantially equivalent (for the indications relerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosuly manactment date of the Medical Device Americal Forley of Food Drus commerce provi to May 20, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been reclassince in accera was a proval approval application (PMA). and Cosment Act (Act) that do not require approvise to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fiel libeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FRA may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Code of I saeral singerning your device in the Federal Register.
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Page 2 – Ms. Sheri L. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fillat IDA s Issualled of a succements with other requirements of the Act that FDA has made a decemination that Jour at 100 received agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 801); good maker 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manus of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of bation 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), please if you desire specific as Compliance at (240) 276-0120. Also, please note the regulation entitled, Conder the Office of Company of Commarket notification" (21CFR Part 807.97). You may obtain Misoranumig by reference to premaintentibilities under the Act from the Division of Small other general informational on your respender Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark McMullan
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
Page __ 1__ of________________________________________________________________________________________________________________________________________________________________
:
| 510(k) Number (if known): | K042895 |
|---|---|
| Device Name: | Synthes (USA) LCP® Dynamic Helical Hip System(LCP DHHS), Additional Helix Blades |
| Indications for Use: | To treat stable and unstable intertrochanteric,subtrochanteric and basilar neck fractures in which astable medial buttress can be reconstructed. |
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
f
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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Number K04 2875
§ 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.