(22 days)
The Self-Compressive Screws are intended for the fixation of bone reconstruction in the hand and in forefoot surgery.
The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
The provided document is a 510(k) premarket notification for a medical device called the "Self-Compressive Screw". It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for the device itself.
Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria, especially in the context of AI/software performance.
Here's why and what information is available:
- Device Type: The device is a "Smooth or threaded metallic bone fixation fastener," which is a physical implant, not a software or AI-driven diagnostic or treatment device.
- Study Type: The document explicitly states "No clinical studies were performed." and primarily relies on non-clinical mechanical testing to demonstrate equivalence.
- Focus of Submission: The entire submission is about demonstrating "substantial equivalence" to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. It's not about proving novel performance against acceptance criteria for a new type of capability.
However, I can provide the mechanical tests performed, which could be interpreted as a form of performance evaluation for this type of device:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied by the performance of the predicate device. The new device is considered "equivalent" if its mechanical performance is comparable to the predicate. No explicit numerical acceptance criteria are stated in the provided text, but the tests performed are:
| Test Name | Standard Used | Reported Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Resistance to torsion | ASTM F543 – Annex 1 | Equivalent to predicate device | Performance comparable to predicate device |
| Pull-out strength | ASTM F543 Annex 3 | Equivalent to predicate device | Performance comparable to predicate device |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the mechanical tests, nor does it provide details on the provenance of data for these non-clinical tests (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device, and "ground truth" in the context of expert review for medical images or diagnoses is not relevant here. The "ground truth" for mechanical testing is established by the physical testing results themselves.
4. Adjudication method for the test set
Not applicable. This concept applies to expert review of data, not to mechanical testing of a physical device.
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. This type of study is not relevant for a metallic bone fixation fastener and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept applies to software/AI algorithms and is not relevant for this physical device.
7. The type of ground truth used
For the mechanical tests, the "ground truth" is the quantitative measurement of mechanical properties according to established ASTM standards. This is not "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/ML device.
In summary, the provided document is for a physical medical device and primarily uses non-clinical mechanical testing and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing an AI/software performance study with specific acceptance criteria as you requested.
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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in a simple, black and white design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Neosteo % JD Webb Official Correspondent The Orthomedix Group, Inc 1001 Oakwood Blvd Round Rock. Texas 78681
Re: K153182
Trade/Device Name: Self- Compressive Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 30, 2015 Received: November 3, 2015
Dear JD Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Self Compressive Screw
Indications for Use (Describe)
The Self-Compressive Screws are intended for the fixation of bone reconstruction in the hand and in forefoot surgery.
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left, followed by the word "neosteo" in orange, and the words "EFFICIENT MOBILITY" in smaller orange font below it. The spiral design is made up of a series of orange lines and dots.
Version 1 Preparation Date: May 2013
l. SUBMITTER'S INFORMATION
A. 510(k) Owner
NEOSTED 2 Rue Robert Schuman 44 400 REZE, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34
B. Contact Person
JD Webb The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Tel: 512 388 0199 Fax: 512 692 3699 Email: jdwebb@orthomedix.net
C. Date of Preparation of the 510(k) Summary
30th October 2015
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Image /page/4/Picture/0 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter orange font.
Version 1 Preparation Date: May 2013
II. DEVICE IDENTIFICATION
A. Trade or proprietary name
Self-Compressive Screw
B. Common or usual name
Self-compressive screw range
C. Classification name
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040, Product code HWC)
D. Class
ll
E. Product code
HWC
CFR section F.
21 CFR 888.3040
G. Device panel
Orthopedic
H. Primary predicate device
The Self-Compressive Screw is similar to the following predicate device which has been cleared via the premarket notification process: Self-Compressive Screw (K131471).
l. Secondary predicate device
The Self-Compressive Screw is similar to the following predicate device which has been cleared via the premarket notification process: Newclip Foot and Hand Motion System (K091118).
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Image /page/5/Picture/0 description: The image contains the logo for "neosteo EFFICIENT MOBILITY". To the left of the text is an orange graphic that resembles a spiral made of lines and dots. The text is also orange and is in a sans-serif font. The word "neosteo" is in a larger font than the words "EFFICIENT MOBILITY".
Version 1 Preparation Date: May 2013
III. DEVICE DESCRIPTION
The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
A. Materials
Titanium alloy per ASTM F136
IV. INTENDED USE
The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in the hand and in the forefoot surgery.
CHARACTERISTICS V. OF SUBSTANTIAL SUMMARY TECHNOLOGICAL EQUIVALENCE
The Self-Compressive Screw is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performances.
VI. NON-CLINICAL TEST SUMMARY
The following mechanical tests were performed:
- -Resistance to torsion according to ASTM F543 – Annex 1
- Pull-out strength according to ASTM F543 Annex 3. -
The results of these testing indicate that the current Self-Compressive Screw is equivalent to predicate device.
VII. CLINICAL TEST SUMMARY
No clinical studies were performed.
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Image /page/6/Picture/0 description: The image contains the logo for Neosteo. The logo consists of an orange spiral design on the left, followed by the word "neosteo" in orange, and the words "EFFICIENT MOBILITY" in smaller orange font below the word "neosteo". The spiral design is made up of a series of orange lines and dots.
Version 1 Preparation Date: May 2013
CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.
NEOSTEO considers the current Self-Compressive Screw to be equivalent to the predicate device listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.
§ 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.