The Flower Bone Screw Set consists of the following components and accessories: solid, cannulated, and headless compression screws, as well as washers, all made of a titanium alloy compliant with ASTM F136. The device is provided with general purpose instruments.

AI/ML Overview

Acceptance Criteria and Study for Flower Bone Screw Set (K132248)

This device, the Flower Bone Screw Set, is a Class II medical device, which means it requires a 510(k) Pre-Market Notification rather than a full PMA (Pre-Market Approval). For 510(k) devices, the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

For this specific device, the "acceptance criteria" are primarily based on established international and national standards for medical devices and a successful engineering analysis rather than specific numerical performance targets against a disease state or condition.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Adhered To)	Reported Device Performance
Material Composition
ASTM F136: Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications	Compliant, Flower Bone Screws made of titanium alloy compliant with ASTM F136.
ISO 7153-1: Surgical instruments Metallic materials Part 1: Stainless steel (for general purpose instruments)	Compliant, general purpose instruments provided with the device.
Biocompatibility
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process	Compliant, biological evaluation performed.
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Compliant, tests for in vitro cytotoxicity performed.
Sterilization
ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Compliant, ensures sterility.
Mechanical Strength/Performance
Engineering analysis demonstrating appropriate mechanical strength for claimed intended use (worse case testing)	Performed; demonstrates appropriate mechanical strength and functioned as intended; test results show substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided documentation does not specify a "test set" in the context of clinical data or patient samples as might be seen for diagnostic AI devices. Instead, the testing described is primarily bench testing and engineering analysis conducted on the device hardware itself.

Sample Size: Not explicitly stated in terms of a discrete number of devices tested for each standard, but it would involve a sufficient number of samples to statistically demonstrate compliance with the relevant ASTM and ISO standards (e.g., destructive testing for mechanical properties, material composition analysis on multiple batches, etc.) and to support the "worse case" engineering analysis.
Data Provenance: The data provenance is from bench testing and engineering analysis performed by the manufacturer, Flower Orthopedics Corporation. This is typically done in a controlled laboratory environment. It is not patient data, nor is it classified as retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is not applicable for this device submission. The "ground truth" for this device's performance is established by:

Industry Standards: Compliance with established international and national standards (ASTM, ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, biomedical engineering, medical device manufacturing, etc.).
Engineering Principles: The engineering analysis relies on established principles of biomechanics, materials science, and mechanical engineering.
Comparison to Predicates: The ultimate "ground truth" for substantial equivalence is the proven safety and effectiveness of the legally marketed predicate devices.

There is no mention of individual clinical experts or "ground truth" labels for a test set of data in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" consists of bench testing and engineering analysis results against predefined standards and engineering principles, there is no need for human expert adjudication in the sense of reviewing diagnostic outcomes or clinical cases. The adjudication is based on whether the test results meet the specified criteria of the standards and the conclusions of the engineering analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned and would not typically be required or relevant for a device like a bone screw set. MRMC studies are employed primarily for diagnostic imaging devices or algorithms where the performance of human readers (with or without AI assistance) on a set of clinical cases is being evaluated. This device is a surgical implant, not a diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the device was conducted. This is represented by the "Performance Data" section which details:

Compliance with various ASTM and ISO standards related to materials, biocompatibility, and sterilization.
An engineering analysis to demonstrate appropriate mechanical strength.

These tests evaluate the device's inherent properties and performance against established benchmarks without direct human interaction as part of the performance metric.

7. Type of Ground Truth Used

The "ground truth" for evaluating the Flower Bone Screw Set is primarily:

Compliance with Established Industry Standards: This includes material specifications (ASTM F136, ISO 7153-1), biocompatibility (ISO 10993-1, ISO 10993-5), and sterilization efficacy (ISO 11137-1).
Engineering Principles and Analysis: The mechanical strength is validated through an engineering analysis based on accepted biomechanical principles and "worse case" testing scenarios.
Substantial Equivalence to Predicate Devices: The overall "ground truth" for regulatory approval via 510(k) is that the device is shown to be as safe and effective as legally marketed predicate devices with the same intended use.

There is no mention of pathology, clinical outcomes data, or expert consensus on clinical cases being used as ground truth for this submission type.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical implant, not an AI/ML algorithm that requires a "training set" of data. The manufacturing processes and design principles are based on established engineering and materials science, not on machine learning models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for such a set.

Summary

{0}------------------------------------------------

K132248

510(k) SUMMARY

Flower Bone Screw Set

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

Flower Orthopedics Corporation 7715 Crittenden Street, #413 Philadelphia, PA 19118

(267) 437 3063 Phone: (267) 437 3072 Facsimile:

OCT 30 2013

Contact Person: Oliver Burckhardt, Chief Executive Officer Date Prepared: October 29, 2013

Name of Device and Name/Address of Sponsor

Flower Bone Screw Set

Common or Usual Name/Classification Name

Bone Fixation Screw

Product Codes: HWC; HTN (Orthopedic Review Panel)

Product Classifications: 21 C.F.R. 888.3040 - Smooth or Threaded Metallic Bone Fixation Fastner: 21 C.F.R. 888.3030 - Single/multiple component metallic bone fixation appliances and accessories

Predicate Devices

Medical Facets Bone Fixation Screws and Pins (K112727) Howmedica Asnis Micro Cannulated Screw (K071092) Treu Bone Fixation Screws and Pins (K083912) Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943) Flower Small and Medium Implant Set (K123562)

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

Technological Characteristics

The Flower Bone Screw Set consists of the following components/configurations:

{1}------------------------------------------------

Cannulated Bone Screws with a diameter range of 2.0-7.3mm and a length range of . 10.0-130.0mm;
Solid Bone Screws with a diameter range of 2.0-4.5mm and a length range of 10.0-● 70.0mm: and
. Headless Compression Bone Screws with a 6.5mm diameter and a length range of 45.0-130.0mm.

Performance Data

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

. ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401);
ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel (ISO . 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;
. ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
. ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
. ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. (Sterility)

In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics cannulated, solid and headless compression bone screws provide appropriate mechanical strength for the claimed intended use.

In all instances, the Flower Bone Screw Set functioned as intended and test results, as well as an engineering analysis, demonstrate substantial equivalence with the cited predicate devices.

Substantial Equivalence

The Flower Bone Screw Set is substantially equivalent to the identified predicate devices. The subject devices have intended uses lindications, technological characteristics, and principles of operation as its predicate devices. An engineering analysis was performed to demonstrate that the Flower Orthopedics cannulated, solid and headless compression bone screws provide appropriate mechanical strength for the claimed intended use. Thus. the subject bone screws are substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

October 30, 2013

Flower Orthopedics Corporation % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K132248

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, HTN Dated: September 18, 2013 Received: September 18, 2013

Dear Ms. Hogan:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Janice M. Hogan

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Erin] - Joseith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): __ K132248

Device Name:

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

and the comments of the comments of the comments of the comments of the comments of the comments of

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Frank -S

Page 1 of 1

Division of Orthopedic 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.