The subject Flower Bone Screw Set is an extension of the Flower Bone Screw Set (K132248) consisting of headless compression screws and cannulated bone screws, made of a titanium alloy compliant with ISO 5832-3. The device is provided with general purpose instruments.

AI/ML Overview

This document is a 510(k) summary for the Flower Bone Screw Set, which is a medical device. It's important to note that this document describes a device (bone screws), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this type of device submission.

The "performance data" section for this hardware device focuses on mechanical testing and material compliance, not clinical performance in the way an AI/ML product would be evaluated.

Here's an analysis of the provided information, with N/A for criteria that don't apply to a physical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested)	Reported Device Performance (Result)
Bacterial Endotoxins Test	The Flower Bone Screw Set was tested (worst case) according to or conforms to ASTM/AAMI ST72.
Mechanical Strength	An engineering analysis was performed to demonstrate that the Flower Orthopedics bone screws provide adequate and substantially equivalent mechanical strength for the claimed intended use.
Material Compliance	Made of a titanium alloy compliant with ISO 5832-3.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document refers to "worst case" testing for bacterial endotoxins and an "engineering analysis" for mechanical strength. For physical devices, "sample size" often refers to the number of units tested, but this level of detail is not provided.
Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The testing was performed on the device itself.

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 hardware device; ground truth in the context of clinical interpretation or diagnosis by experts is not relevant to its type of testing. Engineering and material science experts would have been involved in the design and testing, but their role is different from establishing clinical "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the types of tests (bacterial endotoxin, mechanical strength) performed on bone screws.

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. An MRMC study is not applicable as this is a physical medical device (bone screw), not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For Bacterial Endotoxins: The "ground truth" is adherence to the ASTM/AAMI ST72 standard. The test itself determines the level of endotoxins.
For Mechanical Strength: The "ground truth" is established through engineering analysis and comparison to the mechanical strength of predicate devices, ensuring it is "adequate and substantially equivalent" for its intended use. This is based on established biomechanical principles and regulatory guidances for similar devices.
For Material Compliance: The "ground truth" is the ISO 5832-3 standard for titanium alloy composition.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this physical device.

Summary

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June 6, 2017

Public Health Service

Image /page/0/Picture/2 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 three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Flower Orthopedics Corporation Ms. Jessica Huang Manager, Regulatory Affairs and Quality Assurance 100 Witmer Road. Suite 280 Horsham, Pennsylvania 19044

Re: K170687

Trade/Device Name: Flower Bone Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 5, 2017 Received: May 8, 2017

Dear Ms. Jessica Huang:

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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, Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170687

Device Name

Flower Bone Screw Set

Indications for Use (Describe)

The Flower Bone Screw Set is intended to be used for the fixation of joints or bone reconstruction.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(k) SUMMARY

Flower Bone Screw Set

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Flower Orthopedics Corporation 100 Witmer Road, Suite 280 Horsham, PA 19044

Phone: (215) 323-4018 (215) 394-8904 Facsimile:

Contact Person: Jessica Huang, Manager, Quality Assurance and Regulatory Affairs Date Prepared: June 6, 2017

Name of Device and Name/Address of Sponsor

Flower Bone Screw Set Flower Orthopedics Corporation 100 Witmer Rd. Suite 280 Horsham, PA 19044

Common or Usual Name/Classification Name

Bone Fixation Screw (Product Code: HWC); Product classification: 21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener

Predicate Devices

Flower Bone Screw Set (K132248) Flower Small and Medium Implant Set (K123562) Medical Facet's Bone Fixation Screws and Pins (K112727)

Intended Use / Indications for Use

The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.

Device Description

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Changes from Predicate

The purpose of this submission is to add components to the Flower Bone Screw Set cleared in K132248. The standard construct is modified by adding sizes for Headless Compression Screw and Cannulated Screws not included in the previous submission.

Technological Characteristics

The following components/configurations are being added to the Flower Bone Screw Set:

Cannulated Bone Screws with a diameters of 2.0mm and 2.4mm with additional ● lengths of 6mm and 8mm with total lengths ranging from 6mm to 50mm;
Cannulated Screws of 3.0mm diameter with minor change to thread lengths; ●
Headless Compression Bone Screws with 2.2mm, 3.0mm, 3.5mm, 4.0mm ● diameters and a length range of 6.0-60.0mm.

Performance Data

The Flower Bone Screw Set was tested (worst case) according to or conforms to the following standards:

ASTM/AAMI ST72, Bacterial endotoxins Test methods, routine monitoring, and ● alternatives to batch testing
In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics bone screws provide adequate and substantially equivalent mechanical strength for the claimed intended use.

Conclusion

The Flower Bone Screw set is very similar to the previously cleared Flower Bone Screw Set. The subject devices have the same intended uses and indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the subject devices and the predicate devices raise no new issues of safety or effectiveness. An engineering analysis was performed to demonstrate that the Flower Orthopedics bone screw set provides appropriate mechanical strength for the claimed intended use. Thus, the subject bone screw set is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.