(90 days)
Synthes Hydroxyapatite (HA) Coated Schanz Screws are intended for use with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Synthes HA Coated Schanz Screws are available as self-drilling and non-self-drilling designs. The HA Coated Schanz Screws are available in a variety of diameters and lengths. The threaded portion of the schanz screw is coated with a very thin plasma sprayed coating of HA.
The provided document describes a medical device, the Synthes Hydroxyapatite (HA) Coated Schanz Screws, and its 510(k) premarket notification (K040701). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to prove performance against specific acceptance criteria in the manner typically seen for novel diagnostic algorithms or AI devices.
Therefore, the document does not contain information about acceptance criteria and a study to prove a device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence based on material, design, and indications for use.
Here's an analysis based on the information provided, highlighting why many of your requested points are not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
This table is not applicable in the context of a 510(k) for a medical implant like a Schanz screw, which relies on substantial equivalence to existing devices rather than a performance study with diagnostic metrics. The "performance" for such a device is demonstrated through its similarity to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable for this type of device in a 510(k) submission based on substantial equivalence. | Demonstrated substantial equivalence to predicate devices (Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin) for material, design, and indications for use. |
Explanation: In a 510(k) for devices like bone fixation fasteners, "acceptance criteria" are generally related to demonstrating equivalence in aspects such as:
- Intended Use: Identical or very similar.
- Technological Characteristics: Similar materials, design, operating principles.
- Performance Data: Often non-clinical (e.g., mechanical testing, biocompatibility) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.
The document states: "Documentation is provided which demonstrates that the Synthes HA Coated Schanz Screws is substantially equivalent* to other legally marketed devices." This is the core "performance" claim for a 510(k).
Additional Notes on Acceptance Criteria (Hypothetical for a similar device if performance data were required):
If this were a novel device requiring performance testing, acceptance criteria would typically involve:
- Biocompatibility: Meeting ISO standards for material compatibility with human tissue.
- Mechanical Strength: Withstanding specified forces (e.g., tensile, torsional, bending strength) without failure compared to predicate or physiological loads.
- Fatigue Life: Demonstrating durability under cyclic loading.
- Corrosion Resistance: Meeting standards for material degradation.
- HA Coating Adhesion/Integrity: Demonstrating the coating remains intact and performs as intended.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This 510(k) submission does not describe a clinical "test set" or a study designed to evaluate diagnostic performance against a ground truth. The substantial equivalence relies on comparing the device's design, materials, and indications to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set for diagnostic performance or expert adjudication 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 device is a bone fixation fastener, 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 algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for diagnostic or clinical performance is mentioned as this is a substantial equivalence submission for a surgical implant.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or associated ground truth.
Summary of the K040701 Submission:
The Synthes Hydroxyapatite (HA) Coated Schanz Screws received 510(k) clearance (K040701) by demonstrating substantial equivalence to existing, legally marketed predicate devices: Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin. This means the FDA concluded that the device is as safe and effective as the predicate devices, based on comparable:
- Indications for Use: External fixation for fracture fixation, pseudoarthrosis/non-union, limb lengthening, deformity correction, and joint arthrodesis.
- Technological Characteristics: Made of titanium and stainless steel, with a plasma-sprayed HA coating. Available in self-drilling and non-self-drilling designs, and various diameters and lengths.
The 510(k) process for this type of device typically involves submitting non-clinical data (e.g., mechanical testing, biocompatibility reports) to compare the new device to its predicates, rather than conducting new clinical trials with "acceptance criteria" and "ground truth" as you would for diagnostic software.
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| 3. 510(k) Summary: | K040701 |
|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes (USA) Hydroxyapatite (HA) Coated Schanz Screws |
| Device Classification: | 21 CFR 888.3040 – “Smooth or threaded metallic bonefixation fastener” |
| Predicate Device: | Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin. |
| Description of Device: | Synthes HA Coated Schanz Screws are available as self-drilling andnon-self-drilling designs. The HA Coated Schanz Screws areavailable in a variety of diameters and lengths. The threaded portionof the schanz screw is coated with a very thin plasma sprayed coatingof HA. |
| Indications: | Synthes HA Coated Schanz Screws are intended for use in an externalfixation system for fracture fixation (open and closed);pseudoarthrosis or non-union of long bones; limb lengthening byepiphyseal or metaphyseal distraction; correction of bony or soft tissuedeformity; correction of segmental bony or soft tissue defects; andjoint arthrodesis. |
| Material: | Titanium and stainless steel |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes HACoated Schanz Screws is substantially equivalent* to other legallymarketed devices. |
- The term “substantially equivalent” as used in this 510(k) notification is
limited to the definition of substantial equivalence found in the Food, Drug,
and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,
under which a device can be marketed without pre-market approval or
reclassification. A determination of substantial equivalency under this
notification is not intended to have any bearing whatsoever on the resolution
of patent infringement suits or any other patent matter. No statements related
to, or in support of substantial equivalence herein shall be construed as an
admission against interest under the US Patent Laws or their application by the
courts.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Sheri L. Musgnung Synthes (USA) 1690 Russel Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K040701
Trade/Device Name: Synthes Hydroxyapatite (HA) Coated Schanz Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: HWC Dated: March 16, 2004 Received: March 17, 2004
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 1125 2011 11:14 accordance with the provisions of the Federal Food, Drug, de vices that have been received in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, morelore, mains of the Act include requirements for annual registration, listing of general controls profise wing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (600 as cotrols. Existing major regulations affecting your device can may oe our re-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 I lease be actived that I Dr untion that your device complies with other requirements of the Act that I Dri has made a availations administered by other Federal agencies. You must or any I caetar buttates and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 6077, adoling (21 OFF earlation (21 CFR Part 820); and if applicable, the electronic form in the quisions would provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and h yourse FDA finding of substantial equivalence of your device to a legally premaince notification " 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), please If you desire specific acceants at (301) 594-4659. Also, please note the regulation entitled, Connect the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer 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,
Miriam C. Provost
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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2. Indications for Use
:
Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K040701 |
|---|---|
| Device Name: | Synthes Hydroxyapatite (HA) Coated Schanz Screws |
| Indications for Use: | Synthes Hydroxyapatite (HA) Coated Schanz Screws areintended for use with an external fixation system forfracture fixation (open and closed); pseudoarthrosis ornon-union of long bones; limb lengthening byepiphyseal or metaphyseal distraction; correction ofbony or soft tissue deformity; correction of segmentalbony or soft tissue defects; and joint arthrodesis. |
:
Prescription Use _____________________________________________________________________________________________________________________________________________________________
:
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Synthes (USA) HA Coated Schanz Screw 510(k) Number | K040701 |
|---|---|
| ---------------------------------------------------- | --------- |
000004
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.