The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Device Description

The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position. The design features of the Mediscope Compression Staple are summarized below: - Manufactured from nickel-free stainless steel . - 5 sizes . - Barbs to prevent back out .

AI/ML Overview

The provided text describes a medical device, the "Mediscope Asymmetrical Compression Staple and Accessories," and outlines its submission for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would typically be described for software or AI-based medical devices (e.g., sensitivity, specificity, accuracy against a ground truth dataset).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Wright Medical Compression Staple and Simple Staple, K043059) through engineering testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't define specific "acceptance criteria" for metrics like sensitivity, specificity, or accuracy, because it's not evaluating an AI or diagnostic device in that manner. Instead, the "acceptance criteria" are implied by the performance of the predicate device and the standards followed.

Performance Metric (Implied Acceptance Criteria)	Reported Device Performance (Mediscope Staple)
Elastic Static Bending (per ASTM F564-02)	Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate.
Constant Amplitude Bending Fatigue (per ASTM F564-02)	Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate.
Pull-Out Fixation Strength (per ASTM F564-02)	Tested to demonstrate substantial equivalence to predicate device. Implies performance comparable to the predicate.
Biocompatibility (per ISO 10993-1 (2003)(E))	Testing conducted, implying compliance with biocompatibility standards.

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

Sample Size: Not specified for the engineering tests. ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples) would outline the required sample sizes for these types of mechanical tests.
Data Provenance: Not applicable in the context of human data. The "data" here refers to mechanical test results of the device itself.

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

This question is not applicable. The "ground truth" for a mechanical device is established through physical measurements and adherence to engineering standards (ASTM F564-02) rather than expert human interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing ground truth, typically in diagnostic imaging or clinical studies. This document describes objective mechanical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a physical bone staple.

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

No, a standalone performance evaluation (in the context of an algorithm) was not done. This document is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance of the staple is based on:
- Engineering Standards: Specifically, ASTM F564-02 for mechanical properties (elastic static bending, constant amplitude bending fatigue, pull-out fixation strength).
- Predicate Device Performance: The Mediscope staple's performance in these tests was compared to that of the already cleared predicate device (Wright Medical Compression Staple). Substantial equivalence implies that its performance met or exceeded the predicate's in a way that doesn't raise new questions of safety or effectiveness.
- International Standards: ISO 10993-1 (2003)(E) for biocompatibility.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this traditional device submission. Training sets are used for machine learning models.

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

This question is not applicable for the same reason as point 8.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical bone staple by comparing its mechanical performance and biocompatibility to a predicate device and relevant engineering standards, rather than evaluating an AI or diagnostic algorithm against clinical performance metrics.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENES

Date of Submission

Official Contact / Address of Manufacturing facility

August 9, 2010

Daniel Helme Chief Operating Officer Mediscope Manufacturing Inc. 2832 NW 22nd Terrace Pompano Beach, FL 33069

Phone: 954-975-9997 Fax: 954-975-0775 dhelme@mediscope-mfg.com

Trade Name	Mediscope Asymmetrical Compression Staple and Accessories
Common/Usual Name	Asymmetrical Compression Staple
Device Classification Name	Staple, Fixation, Bone
Classification Reference	21 CFR 888.3030
Classification	Class II
Appropriate Classification Panel	Orthopedic
Product Code	JDR
Predicate Devices	The device is substantially equivalent to:Wright Medical Compression Staple and Simple Staple (K043059)

Reason for submission

New device

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Device Description

The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position.

The design features of the Mediscope Compression Staple are summarized below:

Manufactured from nickel-free stainless steel .
5 sizes .
Barbs to prevent back out .

Indications for Use

The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: r in wedisoope noymined. Ostedtical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus

treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Summary of Testing and Conclusion

The Mediscope Asymmetrical Compression Staple has the following similarities to the previously cleared predicate device:

Same operating principle. ם
Same technology. ロ
O Same intended use.

Substantial equivalency of the Mediscope Asymmetrical Compression Staple and the Wright Medical Charlotte Staple was proven through testing as outlined in ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples). The following is a list of the tests conducted used to compare the two devices: (1) Elastic Static Bending of Metallic Bone Staples; (2) Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples; and (3) Pull-Out Fixation Strength of Metallic Bone Staples.

Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing".

(End of Tab.)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

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

Mediscope Manufacturing, Inc. % Dr. Diane Sudduth Senior RA & OA Consultant 8282 Shadow Wood Boulevard Pompano Beach, Florida 33069

OCT 2 4 2011

Rc: K102387

Trade/Device Name: Mediscope Compression Staple and Accessories 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 16, 2011 Received: September 19, 2011

Dear Dr. Sudduth:

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 - Dr. Diane Sudduth

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.

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/ReportalProblem/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/defaul/htm.

Sincerely yours,

Fan

Mark N. Melkefo Melkerson
Director

On
Division of Surgical, Orthopedic
and Restorative Devices

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102387

Device Name: Mediscope Asymmetrical Compression Staple and Accessories

The Mediscope Asymmetrical Compression Staple is intended to be used for The Mediooope Acymholinshrodesis, mono or bi-cortical osteotomies in the fixaton Suon ao. Lior ano alangeal arthrodesis, Akin osteotomy, midfoot and foreloot, first motatures, fixation of osteotomies for hallux valgus hindloot arthrouses of Colon), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Rines for MRM

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

510(k) Number K902387

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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.