The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

Device Description

The Compressyn Staple is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device. The staple is offered in 14 sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a disposable tray with a drill bit, drill guide, placement pins and staple sizing guide.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Compressyn™ Staple" device. It is a medical device for bone fixation. Here's an analysis of the provided text in relation to acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Information for Compressyn™ Staple

The provided text is a 510(k) summary for a medical device (Compressyn™ Staple). In the context of a 510(k), "acceptance criteria" for showing substantial equivalence are primarily met by demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" in this context refers to the testing performed to support this claim of similarity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit for 510(k) Equivalence)	Reported Device Performance
Intended Use Equivalence: The device's intended use should be substantially similar to that of the predicate device(s).	"The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics."Indications for Use (same as stated on page 2):1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis2) fixation of proximal tibial metaphysis osteotomy3) adjunctive fixation of small bone fragments (in various long, upper, and flat bones).
Technological Characteristics Equivalence: The device's design, materials, and other physical/technical attributes should be substantially similar to the predicate device(s).	"The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics."Specifics: "stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device." Offered in 14 sizes with barbs.
Performance Equivalence: The device should perform in a manner substantially similar to the predicate device, especially regarding critical functions (e.g., compression, delivery).	"The Compressyn Staple was tested for staple delivery and compressive force and was shown to be equivalent to the predicate.""Testing to ASTM F564-10 was also performed for the Compressyn Staple, Preloaded Sterile System."
Safety and Effectiveness (implied): Any differences in technological characteristics should not raise new questions of safety or effectiveness.	Not explicitly stated as a separate criterion, but the overall conclusion of "substantial equivalence" implies this was met.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "The Compressyn Staple was tested for staple delivery and compressive force" and "Testing to ASTM F564-10 was also performed." However, the exact number of staples or test specimens used for these tests is not specified in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). While it's implied the testing was conducted by Dallen Medical, Inc. (USA-based), the location of the testing facility or origin of specific data points is not detailed. The nature of the tests (mechanical performance) suggests laboratory testing rather than clinical data provenance.

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

This information is not applicable and not provided in the context of this 510(k) submission. Mechanical testing (like staple delivery, compressive force, and ASTM F564-10) relies on objective measurements and predefined test standards, not expert clinical assessment or ground truth establishment in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing involves mechanical performance, there is no expert adjudication process in the traditional sense. The results are compared against a predicate device or engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
Effect Size of Human Reader Improvement: Not applicable, as this device is a surgical staple, not a diagnostic imaging AI algorithm that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, this is not an AI algorithm, so a standalone study of this nature was not performed. The device itself is a physical medical device (staple system), and its performance is evaluated through mechanical testing.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

Objective Mechanical Measurements: Such as force measurements for staple delivery and compression.
Adherence to Industry Standards: Specifically, "Testing to ASTM F564-10" refers to a standard test method for metallic bone staples. The ground truth is effectively defined by the requirements and test methodologies outlined in this standard.
Predicate Device Performance: The performance of the predicate device serves as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no "training set" for this device.

Summary

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November 7, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized design. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Dallen Medical, Inc. Al Memmolo Chief Operating Officer 1046 Calle Recodo. Suite G San Clemente, California 92673

Re: K171473

Trade/Device Name: Compressyn™ 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: September 29, 2017 Received: October 3, 2017

Dear Al Memmolo:

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 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 (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for 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

510(k) Number (if known) K171473

Device Name Compressyn™ Staple

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) [X] Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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K171473 PAGE 1 OF 2

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

GENERAL INFORMATION

APPLICANT:	Dallen Medical, Inc.1046 Calle Recodo, Suite GSan Clemente, CA 92673(949) 218-0030(949) 218-0040 Fax
CONTACT PERSON:	Al MemmoloChief Operating Officer
DATE PREPARED:	September 29, 2017
DEVICE DESCRIPTION:
TRADE NAME:	Compressyn™ Staple
GENERIC/COMMON NAME	Fixation Staple
CLASSIFICATION NAME:	Single/multiple component metallic bone fixation appliancesand accessories, CFR 888.3030
PRODUCT CODE:	JDR
DEVICE CLASSIFICATION:	Class II
PREDICATE DEVICES:	Dallen Medical Compressyn Staple, Preloaded Sterile System(K140358)New Deal SA Uni-Clip Staple (K991482)

Product Description:

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Indications for Use:

The Compressyn Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

Technical Characteristics and Performance Data:

The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics. The Compressyn Staple was tested for staple delivery and compressive force and was shown to be equivalent to the predicate. Testing to ASTM F564-10 was also performed for the Compressyn Staple, Preloaded Sterile System.

Basis for Determination of Substantial Equivalence:

Upon reviewing the documentation provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Compressyn Staple is determined by Dallen Medical to be substantially equivalent to existing legally marketed devices.

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.