The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.

AI/ML Overview

The provided text is a 510(k) Summary for the dynaMX™ Tabbed Staple, a medical device for bone fixation. It does NOT describe an AI/ML powered device, nor does it contain information about clinical studies with human readers or AI performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device.

The document focuses on the substantial equivalence of the dynaMX™ Tabbed Staple to predicate devices based on bench testing (laboratory studies), not AI model performance.

Here's a breakdown of the relevant information that IS present, to clarify why your specific questions cannot be answered from this text:

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

Acceptance Criteria (Implied): The document states that "A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging." The implied acceptance criteria are that the device performs comparably to the predicate devices in these bench tests.
Reported Device Performance: The document lists the types of tests performed:
- Elastic Static Bending Testing
- Bending Fatigue Testing
- Staple Pull-Out Force
- Corrosion Testing
- Package Seal Strength Verification
- Transformation Temperature Determination
- However, it does not provide the numerical results or specific acceptance thresholds for these tests. It only states that these studies were conducted to support substantial equivalence.

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

No information on sample size or data provenance is provided as these were bench tests, not clinical studies in humans.

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. This was a bench test involving physical device properties, not clinical assessment requiring expert interpretation to establish ground truth.

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

Not applicable. This was a bench test, not a clinical trial requiring adjudication of clinical findings.

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 MRMC study was done, and no AI component is described. This device is a physical bone fixation staple.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "ground truth" for a physical device in bench testing is typically the actual physical properties measured against engineering specifications or predicate device performance.

8. The sample size for the training set:

Not applicable. This device does not use a training set as it is not an AI/ML model.

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

Not applicable. This device does not use a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

January 28, 2016

MX Orthopedics, Corporation Mr. Howard Schraver Regulatory Affairs Consultant 1 Broadway, 14th Floor Cambridge, Massachusetts 02142

Re: K153129 Trade/Device Name: dynaMXTM Tabbed Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: November 2, 2015 Received: November 3, 2015

Dear Mr. Schrayer:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153129

Device Name dynaMXTM Tabbed Staple

Indications for Use (Describe) The dynaMXTM Tabbed Staple is indicated for:

· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and,

· Fixation of proximal tibial metaphysis osteotomy.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

Name:Contact:	MӾ Orthopedics, Corp.Howard SchrayerRegulatory Affairs Consultant
Address:	1 Broadway, 14th FloorCambridge, MA 02142
Telephone:Fax:	(617) 577 - 3951(617) 812 - 0395
Date Prepared	January 6, 2016

General Device Information

Product Name:	dynaMX™ Tabbed Staple
Classification:	"Bone Fixation Staple"Product code: JDR - Class II21 CFR 888.3030

Predicate Device

Primary Predicate

BioMedical Enterprises	Speed™ Staple(Originally cleared as Osstaple™ Chill)[510(k) Number K102107]
BioMedical Enterprises	OSStaple™ Staple(Originally cleared as Memograph™)[510(k) K993714]
MÄ– Orthopedics, Corp.	dynaMÄ–™ Compression Staple[510(k) K143622]

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Description

The dynaMX™ Tabbed Staple provides a means of bone fixation in the management of fractures and reconstructive surgery.

The dynaMÄ™ Tabbed Staples are made of biocompatible Nitinol. The legs of the . staple are designed to exhibit superelastic properties at room temperature.

Indications for Use

The dynaMX™ Tabbed Staple is indicated for:

Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, ●
Fixation of proximal tibial metaphysis osteotomy.

Substantial Equivalence

A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Tabbed Staple for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.

These tests include:

Elastic Static Bending Testing Bending Fatigue Testing Staple Pull-Out Force Corrosion Testing Package Seal Strength Verification Transformation Temperature Determination

This submission supports the position that the MX Orthopedics dynaMX™ Tabbed Staple is substantially equivalent to previously cleared devices, including those listed above. A number of predicate devices list the same range of clinical uses.

Conclusions

MX Orthopedics. Corp. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the MX Orthopedics dynaMX™ Tabbed Staple. The materials from which the MX Orthopedics device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. The device is substantially equivalent to the referenced predicates.

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.