PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.

Device Description

The design features of the PMT Bone Screws are described below.

Manufactured from Titanium Alloy .
Available headed or headless ●
Available in various diameters and lengths .

AI/ML Overview

This document, K121713, is a 510(k) Premarket Notification for the PMT Bone Screws. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of submission. A 510(k) for a Class II device like a bone screw typically relies on performance testing (e.g., mechanical testing, biocompatibility) to show the new device is as safe and effective as existing legally marketed devices, rather than a clinical study evaluating diagnostic accuracy or a similar performance metric often seen with AI/diagnostic devices.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable to this type of submission:

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

Not applicable in this 510(k) submission. The document does not describe specific acceptance criteria in terms of clinical performance or a table comparing such criteria to reported device performance. For bone screws, acceptance criteria typically relate to mechanical strength, fatigue resistance, and biocompatibility, which are usually demonstrated through bench testing and material specifications, not a clinical study with outcome metrics. The submission asserts substantial equivalence based on design features, material, and indications for use.

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

Not applicable. This submission does not describe a clinical study with a "test set" of patients or data in the way an AI/diagnostic device would. The "test set" concept does not apply to demonstrating substantial equivalence for a bone screw.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" to be established by experts in the context of this 510(k) submission for a bone screw.

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

Not applicable. No adjudication method is described as there is no clinical study, test set, or expert review process mentioned for performance evaluation.

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

Not applicable. This device is a bone screw, not an AI or diagnostic tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

Not applicable. This device is a bone screw, not an algorithm.

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

Not applicable. As the device is a bone screw, "ground truth" in the diagnostic sense is not relevant. Its safety and effectiveness are established through compliance with recognized standards for mechanical properties and biocompatibility, and by demonstrating similar design and material to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" for a bone screw device as described in this 510(k) submission.

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

Not applicable. Since there is no training set mentioned, this question is also not applicable.

Summary of Information from K121713 relevant to device acceptance:

The primary "acceptance criteria" for K121713 are implicitly met by demonstrating substantial equivalence to predicate devices. The study proving the device meets these criteria is the entire 510(k) submission itself, which articulates how the device is equivalent to already cleared devices.

Device: PMT Bone Screws
Intended Use: Bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Approach to Acceptance: Substantial Equivalence to predicate devices: Wright Compression Screws (K082320) and ORTHOLOC Bone Screws (K112772).
Evidence presented for Substantial Equivalence:
- Design features (Manufactured from Titanium Alloy, available headed or headless, various diameters and lengths – common for bone screws).
- Material (Titanium Alloy – common and well-characterized for orthopedic implants).
- Indications for Use (identical to, or within the scope of, predicate devices).
- "Materials information, and analysis data" (not detailed in the provided snippets, but typically would include biocompatibility data, mechanical testing results showing compliance with relevant standards like ASTM F543 for metallic bone screws, and possibly dimensional comparisons).

The FDA's decision to clear the device (SEP 27 2012) signifies their acceptance that the device is "substantially equivalent" to legally marketed predicate devices and thus is as safe and effective.

Summary

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Providence Medical Technology, Inc.

Section 5. 510(k) Summary

PMT Bone Screws K121713 ( 1/2)

SEP 27 2012

510(k) Owner:	Providence Medical Technology, Inc.
	201 Spear Street, Suite 1310
	San Francisco, CA. 94105
	T: 415-923-9376
	F: 415-923-9377
Contact Person:	Glen Mangseth
	gmangseth@providencemt.com
	T: 415-923-9376
Date Summary Prepared:	June 10, 2012
Trade Name:	PMT Bone Screws
Common Name:	Bone Screw
Device Classification Regulation:	21 CFR 888.3040 - Class II
Device Product Code & Panel:	HWC: Screw, Fixation Bone
	87, Orthopedics
Predicate Device:	Wright Compression Screws (K082320)
	ORTHOLOC Bone Screws (K112772)

Device Information

A. Intended Use

The PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.

B. Device Description

The design features of the PMT Bone Screws are described below.

Manufactured from Titanium Alloy .
Available headed or headless ●
Available in various diameters and lengths .

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PMT Bone Screws
K 121713 (2/2)

C. Substantial Equivalence Information

The design features, material, and indications for use of the PMT Bone Screws are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the PMT Bone Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

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

SEP 27 2012

Providence Medical Technology, Incorporation % Mr. Glen Mangseth Quality Systems Manager 201 Spear Street, Suite 1310 San Francisco, California 94105

Re: K121713

Trade/Device Name: PMT Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 20, 2012 Received: August 20, 2012

Dear Mr. Mangseth:

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

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Page 2 - Mr. Glen Mangseth

CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Section 4. Indications for Use Statement

Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known):

· Device Name: PMT Bone Screws

Indications for Use:

PMT Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashb

Page 1 of 1

(Division Sign-Cil) Division of Surgual. Orthopedic, and Restorative Devices

×1273 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.