This document describes the Rotation Medical Bone Staple (RMB Staple) and its approval through the 510(k) pathway. The goal of the 510(k) process is to demonstrate substantial equivalence to legally marketed predicate devices, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Pre-Market Approval) study would.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" needs to be interpreted within the context of a 510(k) submission, where the "acceptance criteria" are the demonstration of similarity in intended use, technological characteristics, and safety and performance testing to predicate devices. The "study" is the battery of tests performed to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, there isn't a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding study results in the traditional sense, as there would be for a device seeking novel claims or a PMA. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating the device is as safe and effective as a legally marketed predicate through a comparison of technological characteristics and performance in pre-clinical studies (in vitro and in vivo bench and animal testing).

The document states:

"The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices."
"The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices."

Therefore, the "acceptance criteria" are the successful completion and positive results from these specific tests, showing comparability to the predicate devices.

Acceptance Criteria (Demonstrated through testing)	Reported Device Performance (Implied by conclusion)
Biocompatibility: Meet FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards for biological evaluation.	Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. Confirmed to be biocompatible through cytotoxicity, sensitization, intracutaneous reactivity, toxicity, and animal testing with histology.
Product Characterization (In vitro): Demonstrate similar characteristics to predicate.	Results from in vitro product characterization studies support substantial equivalence.
Bench Testing (In vitro): Evaluate performance characteristics (e.g., strength, retention).	Results from bench testing (including strength and retention) support substantial equivalence. The RMB Staple is optimized for fixation to bone, differentiating it from one predicate (Ethicon Securestrap™) but aligning with the material (PEEK) and bone fixation goal of the other (SwiveLock Anchor), albeit with direct vs. indirect fixation.
Animal Efficacy (In vivo): Assess performance in a biological model.	Results from the animal efficacy study demonstrate safety and substantial equivalence.
Substantial Equivalence: Demonstrate that the RMB Staple is as safe and effective as the predicate devices.	The conclusion explicitly states the device is "safe and substantially equivalent to the predicate devices" based on the performed studies.

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

The document does not specify exact sample sizes for the individual in vitro or in vivo tests performed. It generically mentions "number of in vitro and in vivo tests."

Data Provenance: The tests are pre-clinical studies (in vitro and in vivo animal testing), not human clinical data. The country of origin for the data is not specified, but typically these tests would be conducted by or for the applicant (Rotation Medical, Inc. based in Plymouth, MN, USA). The studies are inherently "prospective" in the sense that they were conducted specifically for this submission.

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

This information is not applicable to this type of submission. "Ground truth" established by human experts for a test set (e.g., radiologists interpreting images) is relevant for AI/CADe device submissions or clinical trials requiring human assessment of outcomes. For a medical device like a bone staple, the "ground truth" or acceptability is determined by physical and biological performance against established scientific standards and comparison to predicate devices, not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert interpretations in clinical studies or AI validation, which is not the nature of the studies described here.

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

No, an MRMC study was not done. MRMC studies are specific to evaluating the impact of AI on human readers for diagnostic or screening tasks (e.g., radiology interpretation). This device is a mechanical implant, and its assessment involves pre-clinical performance testing, not human reader studies.

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

Not applicable. This device is a bone staple, not an algorithm or AI system. Its performance is evaluated through material science, mechanical testing, and biocompatibility, not as a standalone algorithm.

7. The Type of Ground Truth Used

For the pre-clinical tests, the "ground truth" is based on:

Scientific Standards: Meeting established FDA and ISO standards for biocompatibility (e.g., ISO 10993-1, FDA Blue Book Memorandum G95-1).
Engineering Specifications/Benchmarking: Performance metrics (strength, retention) are evaluated against pre-defined engineering requirements and/or compared to the performance of the predicate devices.
Histopathology: In animal studies, histological analysis would be used to assess tissue response and integration, with findings interpreted by veterinary pathologists or similar experts.
Gross observation of efficacy: In animal efficacy studies, the "efficacy" (e.g., successful fixation of tissue to bone) would be observed and measured.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI model that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Rotation Medical. The logo consists of a series of circles arranged in a semi-circular pattern, with some of the circles filled in with a darker color. Below the circles is the word "rotation" in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font. To the right of the logo is the number K131633.

K131635 Page 1/2

AUG 2 9 2013

510(k) Summary

Applicant Information

Applicant Name:	Rotation Medical, Inc.
Applicant Address:	15350 25th Avenue North, Suite 100
	Plymouth, MN 55447
Telephone:	763-746-7521
Fax:	763-746-7501
Contact Person:	Gail SchroederDirector, Quality Assurance and Operations
Date Prepared:	August 27, 2013

Name of Device

Device Common Name: Device Trade Name: Device Classification Name: Nondegradable soft tissue to bone fixation staple Rotation Medical Bone Staple (RMB Staple) Bone Fixation Fastener 888.3040 Class II MBI

Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s):

Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K093845; Ethicon, Inc.

SwiveLock Anchors, K101823 Arthrex, Inc.

Description of the Device

The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is composed of PEEK material. The RMB Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical. (Note: Rotation Medical's orthopedic manual staple driver is a Class I exempt device pursuant to 21 CFR 888.4540 and is not the subject of this submission).

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Image /page/1/Picture/0 description: The image shows the logo for Rotation Medical, along with the text "K131635 Page 2/2". The logo consists of the word "rotation" in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font. Above the logo is a circular design made up of several circles, some of which are filled in with different shades. The text "K131635 Page 2/2" is located to the right of the circular design.

intended Use

The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.

Summary/Comparison of Technical Characteristics

The RMB Staple and the predicate device, Ethicon Securestrap™, have similar indications for use and physical design. Both devices are indicated for the fixation of prosthetic material, and are comprised of a polymer strap with barbed ends. The Securestrap™ is optimized for soft tissue fixation, while the RMB Staple is optimized for fixation to bone. The RMB Staple and the predicate device, SwiveLock Anchor, are made of the same material, PEEK, and are used similarly to aid in the management of tendon injuries by affixing a prosthetic material to bone. The RMB Staple directly affixes the prosthetic material to bone, while the predicate SwiveLock indirectly affixes the prosthetic material by proving an anchor point for sutures which have been sewn to/through the prosthetic material.

RMB Staple has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility and substantial equivalence to the predicates, including: cytotoxicity, sensitization, intracutaneous reactivity, toxicity, and animal testing with histology. In addition, in vivo and in vitro strength and retention were also assessed.

Conclusion

The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 29, 2013

Rotation Medical, Inc. Gail Schroeder Director, Quality Assurance and Operations 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447

Re: K131635

Trade/Device Name: Rotation Medical Bone Staple (RMS Staple) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 23, 2013 Received: July 24, 2013

Dear Ms. Schroeder:

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 - Gail Schroeder

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/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/Medica|Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S

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

Enclosure

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Confidential Rotation Medical, Inc.

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Rotation Medical Bone Staple (RMB Staple)

Indications for Use:

The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131635

Page 1 of _1

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.