The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Device Description

The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.

AI/ML Overview

The provided text describes a medical device submission (510(k)) for the Proximal Humerus Scaffold Fixation System (PHSFS). This is a device for surgical fixation, not an AI/ML powered device, therefore the typical metrics for AI/ML device evaluations (like sensitivity/specificity, AUC, agreement with ground truth, MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth) are not applicable in this context.

This document describes a medical device, not an AI/ML powered device. Therefore, the standard AI/ML acceptance criteria and study components requested in the prompt (e.g., sensitivity, specificity, MRMC studies, training/test set sizes, expert qualifications) are not relevant to this content.

Instead, the acceptance criteria for this type of device are primarily based on substantial equivalence to a legally marketed predicate device and compliance with recognized consensus standards.

Here's an interpretation of the provided information in the context of a 510(k) submission for a non-AI medical device:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Material Compliance: Device materials meet recognized standards for surgical implants.	- Complies with ASTM F136-02a (Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications).- Complies with ASTM F899-07 (Stainless Steel for Surgical Instruments).
Substantial Equivalence (Technological Characteristics): The device has technological characteristics that are essentially identical to a legally marketed predicate device.	A 15-point comparison of technological characteristics was performed with the Synthes LCP Proximal Humerus Plate. The devices were found to be substantially equivalent.
Substantial Equivalence (Performance Characteristics): The device performs as well as or better than the predicate device across key performance parameters.	A multi-parameter comparison of mechanical performance was conducted with the Synthes LCP Proximal Humerus Plate. The devices were found to be substantially equivalent.
Safety and Effectiveness: The device is considered safe and effective for its intended use.	Based on compliance with stated standards and technological characteristics essentially identical to the predicate, the device is believed to be safe and effective and performs as well as or better than the predicate device. The implantable and tissue contact materials have a long history of safe usage in medical devices.
Intended Use: The device performs its intended function for specified indications.	Indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus. This aligns with or is comparable to the predicate device's indications.

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

Not Applicable (N/A) for an AI/ML context.
For a mechanical medical device, "test set" typically refers to the physical units subjected to material and mechanical testing. The document does not specify the number of units tested, but rather refers to ASTM standards and "multi-parameter comparison of mechanical performance" implicitly requiring testing on a sufficient number of samples to demonstrate compliance and equivalence.
Data Provenance: The data comes from the manufacturer's (TOBY Orthopaedics) internal testing and comparisons, implicitly conducted in the USA (where the company is located and the submission is made to the FDA). The data is retrospective in the sense that it evaluates the device after its design and manufacturing, but for a 510(k), it's a pre-market submission demonstrating intended performance.

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

Not Applicable (N/A) for an AI/ML context.
For this type of device, "ground truth" is established by adherence to engineering standards (e.g., ASTM) and demonstrated performance relative to a predicate device. This is typically evaluated by engineers and materials scientists with expertise in biomechanics, materials science, and medical device design. The document does not specify the number or qualifications of individuals who performed or reviewed these tests, but it is implied they were qualified professionals.

4. Adjudication Method for the Test Set

Not Applicable (N/A) for an AI/ML context.
For a mechanical device, "adjudication" usually refers to the process of reviewing test results against predefined acceptance criteria. This would typically involve internal quality control and regulatory affairs professionals from the manufacturer, and subsequently, the FDA reviewers in the Office of Device Evaluation. The document doesn't detail the internal adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was NOT done. This type of study is specific to AI/ML devices or diagnostic imaging interpretation where human readers' performance is being evaluated.
For this mechanical device, comparative effectiveness is demonstrated by showing "substantial equivalence" of technological and performance characteristics to a predicate device.

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

Not Applicable (N/A). This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used

Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is compliance with established engineering material standards (ASTM F136-02a, ASTM F899-07) and the known, safe, and effective performance of the legally marketed predicate device (Synthes LCP Proximal Humerus Plate). The ground truth for materials is defined by the ASTM specifications, and for functional performance, it is defined by the predicate device's established mechanical properties.

8. The sample size for the training set

Not Applicable (N/A) for an AI/ML context. There is no "training set" for a mechanical device. The design and manufacturing processes are refined through engineering development, prototyping, and testing, but not in the "training" sense of machine learning.

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

Not Applicable (N/A) for an AI/ML context. As there is no training set as understood in AI/ML, this question does not apply. The materials and performance characteristics of the device were chosen based on established engineering principles, regulatory requirements, and the characteristics of the predicate device.

Summary

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Image /page/0/Figure/2 description: This document is a summary of safety and effectiveness for the Proximal Humerus Scaffold Fixation System (PHSFS). It was submitted by TOBY Orthopaedics, located at 3773 Matheson Avenue in Miami, Florida 33133, with the phone number 1 (305) 495-3115. The document is dated December 19, 2008, and the contact person is Al Weisenborn. The device trade name is Proximal Humerus Scaffold Fixation System (PHSFS), the common name is Shoulder Plate, and the classification name is Single/multiple component metallic bone fixation appliances and accessories per 21 CFR § 888.3030.

Identification of a Legally Marketed Predicate Device

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA).

Device Description

Intended Use

The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Summary of Technological Characteristics

A 15-point comparison of technological characteristics and a 4-point comparison of performance characteristics of the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) and the predicate device were performed. The devices were found to be substantially equivalent.

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Summary of Performance Data

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) complies with the requirements of listed FDA Recognized Consensus Standards.

ASTM F136-02a, Standard Specification for Wrought Titanium-6 Alumi-num-4 . Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401))
ASTM F899-07, Standard Specification for Stainless Steel for Surgical In-. struments

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA) This has been demonstrated through a 15-point technological comparison of features and a multi-parameter comparison of mechanical performance.

The implantable and tissue contact materials used to fabricate the Proximal Humerus Scaffold Fixation System (PHSFS) and Instruments have a long history of safe usage in medical devices. Because the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS)s meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEC 1 9 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TOBY Orthopaedics, LLC % Mr. Al Weisenborn 3773 Matheson Avenue Miami, Florida 33133

Re: K081608

Trade/Device Name: Proximal Humerus Scaffold Fixation System (PHSFS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 25, 2008 Received: November 28, 2008

Dear Mr. Weisenborn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Al Weisenborn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Millenson

Mark N. Melkerson 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 1
510(k) Number (if known):	K081608
Device Name:	Proximal Humerus Scaffold Fixation System (PHSFS)
Indications for Use:

The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Prescription Use X(Per 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K081608
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TOBY Orthopaedics

Regulation Number and Section

§ 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.