Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
Diaphyseal fractures .
Ankle fractures .
Simple, comminuted and depression fractures ●
Non-unions and malunions .
Osteotomies and bone reconstruction t
Fractures in normal or osteoporotic bone 9

Device Description

The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "AngleFix T Locking Plate." However, it is important to note that a 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study in the way requested in the prompt.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The document does not provide a table of acceptance criteria or reported device performance in the context of a clinical study or specific performance metrics. Instead, it states:

"The pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use."

This statement indicates that the "acceptance criteria" were likely related to demonstrating similarity in design, materials, and mechanical performance to legally marketed predicate devices, rather than achieving specific clinical outcomes or accuracy thresholds.

Therefore, I cannot populate the table below with specific performance metrics as they are not present in the provided text.

Acceptance Criteria	Reported Device Performance
Not specified in the document as distinct acceptance criteria for clinical performance.	"Substantially equivalent to the predicate devices and is adequate for the intended use."

Here's a breakdown of the other requested information based on the provided text:

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

The document does not specify a sample size for a test set or data provenance related to human or imaging data. The performance testing mentioned is "pre-clinical," suggesting bench testing or possibly cadaveric studies, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there is no mention of a test set requiring expert-established ground truth (e.g., for image interpretation). The submission focuses on device equivalence through pre-clinical testing.

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

This information is not applicable for the same reasons as point 3.

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

This is not applicable. The device is a T Locking Plate for bone fixation, not an image analysis or AI-driven diagnostic tool. Therefore, no MRMC study or AI assistance is mentioned or relevant.

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

This is not applicable for the same reasons as point 5.

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

The concept of "ground truth" as it relates to clinical outcomes, pathology, or image interpretation is not applicable here. The "ground truth" for demonstrating substantial equivalence for this type of device typically involves engineering specifications, material properties, and mechanical performance tests compared against predicate devices.

8. The sample size for the training set

This is not applicable as there is no mention of a "training set" or AI model development.

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

This is not applicable for the same reasons as point 8.

Summary of what the document does indicate:

Device Type: AngleFix T Locking Plate, a metallic bone fixation appliance.
Purpose of Submission: 510(k) premarket notification to establish substantial equivalence.
Predicate Devices: Howmedica VariAx Locking plate System (K060613), Synthes AxSOS Plus Locking Plate System (K061012), and Synthes 3.5mm LCP Distal Humerus System (K033995).
Performance Testing: "Pre-clinical testing" was performed, which "indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use." This typically involves mechanical and material testing to ensure the device meets engineering specifications comparable to existing devices, without involving patient data for "ground truth" in the diagnostic sense.

Summary

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

SEP 0 8 2009

K0916619

4. 510(k) Summary according to 807.92(c)

Contact:	Mike SinsheimerAngleFix Tech, LLC.1723 Beverly DriveCharlotte, NC 28207704-363-7532
Trade Name:	AngleFix T Locking Plate
Product Class:	Class II
Classification:	21 CFR §888.3030Single/multiple component metallic bone fixationappliances and accessories
Product Codes:	KTT
Panel Code:	87

Indications for Use: The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:

Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
Diaphyseal fractures .
Ankle fractures .
Simple, comminuted and depression fractures ●
Non-unions and malunions .
Osteotomies and bone reconstruction t
Fractures in normal or osteoporotic bone 9

The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.

Predicate Device(s):

Device Description:

and the Synthes AxSOS Plus Locking Plate System (K061012).

Performance Testing:

The pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use.

Howmedica VariAx Locking plate System (K060613), the

Synthes 3.5mm LCP Distal Humerus System (K033995)

e i of

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem in the center. The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design incorporated into it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

SEP 0 8 2009

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

AngleFix Tech, LLC % Silver Pine Consulting Mr. Richard Jansen, Pharm D. 135 Guild Avenue Apple Valley, Minnesota 55124

Re: K091619

Trade/Device Name: AngleFix T Locking Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: KTT Dated: May 31, 2009 Received: June 10, 2009

Dear Mr. Jansen

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 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 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.

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

Page 2- Mr. Richard Jansen, Pharm D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Barbara Buchend

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

Enclosure

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

3. Statement of Indications for Use

510(k) Number (if known): (09116 19

Indications for Use:

The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:

Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
Diaphyseal fractures .
Ankle fractures .
Simple, comminuted and depression fractures .
Non-unions and malunions
Osteotomies and bone reconstruction
Fractures in normal or osteoporotic bone

Prescription Use 1 (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souita for mxm
(Division Sign O

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K09) 6/9

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.