The modified KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair sutures or suture tape within the implant.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving a device meets these criteria. The document is a 510(k) premarket notification for a medical device (KATOR Suture Anchor) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what I can extract and why some parts of your request cannot be answered from this text:

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

The document states: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities." However, it does not explicitly list the specific acceptance criteria or the numerical results of the performance tests. It only lists the types of tests performed.

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

This information is not provided in the document. The text mentions "verification tests" and "testing as summarized in the Design Control Activities Summary" but does not detail the sample sizes or the provenance of the test data.

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)

This is not applicable as the document describes mechanical testing of a medical implant (suture anchor), not an AI or diagnostic imaging device that would typically rely on expert-established ground truth.

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

This is not applicable for the same reason as point 3.

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

This is not applicable as the document is about a mechanical medical device, not an AI or diagnostic imaging system involving human readers.

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

This is not applicable as the device is a physical suture anchor, not an algorithm.

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

This is not applicable in the context of mechanical device testing. The "ground truth" for mechanical performance is typically defined by engineering specifications and standards.

8. The sample size for the training set

This is not applicable as the document describes a mechanical medical device, not a machine learning model that would have a training set.

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

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

Summary of what can be extracted from the document:

Device Name: KATOR Suture Anchor
Purpose of Study: Verification testing to demonstrate that the modified KATOR Suture Anchor met pre-determined acceptance criteria and introduced no new issues of safety or effectiveness compared to its predicate device (K152236).
Types of Tests Performed:
- Static Performance Testing
- Dynamic Performance Testing
- Limulus Amebocyte Lysate (LAL) testing for endotoxin levels.
Outcome of Testing: "The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities."
Ground Truth (Implicit): For mechanical tests, the ground truth would be defined by the engineering specifications and relevant ASTM or ISO standards for suture anchors. For endotoxin levels, it's defined by acceptable limits established using LAL testing.
Data Provenance: Not specified, but generally, such testing for 510(k) submissions is performed in a controlled laboratory environment.

To provide the detailed information you requested (specific acceptance criteria, numerical performance data, sample sizes, etc.), you would need access to the "Design Control Activities Summary" mentioned in the document, which is not included in the provided text.

Summary

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

October 25, 2016

KATOR LLC Mr. Robert Hoy Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321

Re: K162386

Trade/Device Name: KATOR Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 27, 2016 Received: September 27, 2016

Dear Mr. Hoy:

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,

Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, creating a clean and legible presentation of the name. The background is plain, ensuring the focus remains on the text.

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

Enclosure

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Indications for Use

510(k) Number (if known)

K162386

Device Name KATOR Suture Anchor

Indications for Use (Describe)

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

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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510(k) Summary 5.

Device Trade Name:	KATOR Suture Anchor
Manufacturer:	KATOR LLC124 South 600 West, Suite 100Logan, UT 84321
Contact:	Mr. Robert HoyDirector of ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@surgicalfrontiers.com
Prepared by:	Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	October 25, 2016
Common Name:	Screw, Fixation, Bone
Classification:	21 CFR 888.3040, Smooth or threaded metallic bonefixation fastener
Class:	II
Product Code:	MBI

Indications for Use:

The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

Device Description:

Predicate Device:

The KATOR Suture Anchor (K152236) is the predicate device.

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Technological Characteristics Comparison:

The modified KATOR Suture Anchor and its predicate device are offered in the same sizes and have nearly identical shapes. Both devices are generally cylindrical and have rib features on their outer diameter for engaging bone tunnel walls via an interference fit. In addition, both devices are designed to be deployed in conjunction with suture and contain suture locking pins. The modified KATOR Suture Anchor and predicate device are both manufactured from polyetheretherketone (PEEK). There are no substantial differences in technological characteristics between the two devices and as such the KATOR Suture Anchor introduces no new issues of safety or effectiveness.

Nonclinical Testing:

The subject device design was evaluated with the following verification tests, using the same methods performed on the predicate device in submission K152236:

. Static Performance Testing
Dynamic Performance Testing

The results of this testing as summarized in the Design Control Activities Summary demonstrate that the modified KATOR Suture Anchor met the pre-determined acceptance criteria for the verification activities. Therefore, the differences between the modified and predicate devices introduce no new issues of safety or effectiveness.

Acceptable endotoxin levels were established using limulus amebocyte lysate (LAL) testing. A plan for future endotoxin monitoring was proposed.

Conclusion:

The modified KATOR Suture Anchor met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Indications/Intended Use and the fundamental scientific technology of the modified KATOR Suture Anchor are the same as those described in the predicate device. Based on similarities to its predicate, the modified KATOR Suture Anchor is substantially equivalent to the predicate KATOR Suture Anchor (K152236).

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.