The Universal Bone Plate (UBP) System II is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand.

Device Description

The UBP System II is intended bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand. The UBP System II consists of canted, variable-distance multi-hole bone plates, cortical and cancellous screws, and instrumentation. The UBP System II instrumentation set consists of the standard instrumentation required for each indicated procedure. Implants are for single use only.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Spinal Concepts, Inc. Universal Bone Plate (UBP) System II. This type of submission is for medical devices that claim substantial equivalence to a predicate device, rather than demonstrating performance against acceptance criteria through clinical studies in the way a pharmaceutical or novel high-risk medical device might.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or ground truth establishment relevant to an AI/Software as a Medical Device (SaMD) context.

Instead, the "study" demonstrating the device meets "acceptance criteria" for substantial equivalence is primarily a mechanical testing comparison and a technological comparison to its predicate device.

Here's an interpretation of the request in the context of this document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Comparable static and fatigue performance to the predicate device and able to withstand clinical loading.	Static and fatigue testing "demonstrated the UBP System II bone plate to be substantially equivalent to the existing UBP System bone plate, and able to withstand clinical loading and maintain mechanical integrity."
Material Equivalence: Same material as the predicate.	Both UBP System II and UBP System (Original/Predicate) implants use Titanium 6AL-4V.
Functional Equivalence: Same intended use.	Both UBP System II and UBP System (Original/Predicate) have the function "To bring together bone fragments in order to augment fracture healing" and the indication "To bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand."

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified in terms of number of devices. The "test set" here refers to the samples of UBP System II and existing UBP System bone plates used for mechanical testing.
Data Provenance: The data comes from "Static and fatigue testing" performed directly by Spinal Concepts, Inc. The location or specific laboratory for this testing is not explicitly stated, but it's generated for this 510(k) submission.

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 comparison and does not involve expert-established ground truth for a test set in the clinical or imaging analysis sense.

4. Adjudication method for the test set:

Not applicable. No adjudication method is described as this is not a diagnostic device involving human interpretation.

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 is a bone plate, not an AI or imaging device, so MRMC studies are not relevant.

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

No. This is not an algorithm-based device.

7. The type of ground truth used:

For the mechanical testing, the "ground truth" would be the measured physical properties (e.g., strength, fatigue life) under specific test conditions, compared to the predicate device's measured properties and published data for similar devices. There isn't a "ground truth" in the sense of a definitive diagnostic label.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning device.

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

Not applicable.

Summary

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Spinal Concepts, Inc. Universal Bone Plats (UBP) System II Pre-market Notification September 18, 1997

K973586

SUMMARY OF SAFETY AND EFFECTIVENESS UNIVERSAL BONE PLATE SYSTEM II (TITANIUM)

STITUTAL UNIVERSITY

General Information 】.

ז - NOV

Classification Name:	Single/multiple component metallic bone fixationappliances and accessories.
Common Name:	Titanium Bone Plate and Screws
Device Trade Name:	Universal Bone Plate (UBP) System II
Classification Code:	87HRS87HWC
Submitter's Name & Address:	Spinal Concepts, Inc.8200 Cameron Road, Suite B-160Austin, Texas 78754 U.S.A.(512) 339-4800
Establishment Registration No: 1649384	Contact Person:Teena M. AugostinoDirector, Clinical and Regulatory Affairs
Summary Preparation Date:	September 18, 1997

II. Predicate Device

The Spinal Concepts, Inc. Universal Bone Plate (UBP) System II is claimed to be substantially equivalent in material, design, and function to the existing UBP System.

III. Device Description

IV. Sterilization

UBP System II implants and instrumentation may be provided sterile. Both implants and instruments must be sterilized prior to use in accordance with the recommended sterilization parameters described in the package insert in order to achieve a sterility assurance level of 10-6.

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V. Indications for Use

The UBP System II is indicated as a means to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand.

Substantial Equivalence VI.

The UBP System II is considered to be substantially equivalent to the existing UBP System.

	Technological Comparison of Devices
	UBP System IIImplants	UBP System Implants(Original/Predicate)
Material	Titanium 6AL-4V	Titanium 6AL- 4V
Design	Canted, variable-distance, multi-hole boneplates.Cortical and cancellousbone screws in a rangeof sizes.Radiused, reduced cross-sectional profile height.	Non-canted, fixed-distance,multi-hole bone plates.Bone screw with a singlethreaded profile.Non-radiused cross-sectional profile height.
Function	To bring together bonefragments in order toaugment fracturehealing	To bring together bonefragments in order toaugment fracture healing.
Indication	To bring together bonefragments in order toaugment fracture healingof the small bones of thefoot, wrist and hand.	To bring together bonefragments in order toaugment fracture healing ofthe small bones of the foot,wrist and hand.

VII. Mechanical Testing

Static and fatigue testing was performed on the UBP System II bone plates and the existing, commercially available UBP bone plates. These data were compared with published data of various bone plates used for long bone fixation. The results of this testing demonstrated the UBP System II bone plate to be substantially equivalent to the existing UBP System bone plate, and able to withstand clinical loading and maintain mechanical integrity.

VIII. Conclusion

The UBP System II is considered to be substantially equivalent in design, material and function to the existing UBP System. The results of mechanical testing demonstrate that the UBP System II bone plate is equivalent in static and fatigue performance to the existing UBP System bone plate. The UBP System II is believed to perform as well as or better than the existing UBP System.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 1997

Ms. Teena M. Augostino Director, Regulatory and Clinical Affairs Spinal Concepts, Inc. 8200 Cameron Road, Suite B-160 Austin, Texas 78754

Re : K973586 Universal Bone Plate (UBP) System II Requlatory Class: II Product Codes: HWC and HRS Dated: September 18, 1997 Received: September 22, 1997

Dear Ms. Augostino:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section Class III devices are required to have an 513 (f) of the Act. approved premarket approval (PMA) application prior to marketinq. Accordingly :

The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and

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Page 2 - Ms. Teena M. Augostino

You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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Page 3 - Ms. Teena M. Augostino

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

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1973586 510(k) Number (if known): Device Name: Universal Bone Plate (UBP) System II

Indications for Use:

The Universal Bone Plate (UBP) System II is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter (Optional Format 1-2-96)

Dcolle

(Division Sign-Off) Division of General Restorative Devices 510(k) Number .

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.