The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

Device Description

The Pivot NanoTack Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a stainless steel Inserter. The NanoTack Suture Anchor with Inserter is provided as a single-use sterile device.

AI/ML Overview

Based on the provided text, the device in question is the NanoTack Suture Anchor 1.4mm, a non-degradable suture anchor intended for the fixation of soft tissue to bone in the hip, specifically for the reattachment of the hip labrum to the acetabulum.

However, the provided document does not contain the details necessary to answer all parts of your request. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria, performance metrics, or ground truth establishment.

Here's an attempt to answer as much as possible based on the given text, with explicit notes for missing information:

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

Acceptance Criteria	Reported Device Performance
Mechanical Properties Demonstrating Substantial Equivalence to Predicate Devices: This is implied as the primary acceptance criterion for 510(k) clearance, rather than specific numerical criteria. The NanoTack Suture Anchor must perform equivalently to its predicates in terms of insertion and fixation properties.	"The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors." (Page 1 of 2, "Summary of Performance Testing")

Missing Information: Specific quantifiable acceptance criteria (e.g., minimum pull-out strength, insertion torque, etc.) and the detailed numerical results from the performance testing are not provided in this summary.

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

Missing Information: The document does not specify the sample size for any test set (e.g., how many anchors were tested, how many times). It also doesn't mention the data provenance (country of origin, retrospective/prospective).

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 to this type of device and study. The "ground truth" concept usually applies to diagnostic or prognostic devices where a true clinical state needs to be determined by human experts. For a mechanical device like a suture anchor, "ground truth" would relate to its physical properties and mechanical performance, which are measured using engineering tests, not expert consensus.

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

Not applicable for the reasons stated above (mechanical device, not diagnostic).

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

Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool or a device that involves human "readers" interpreting images. Therefore, an MRMC study and AI improvement effect size are not relevant.

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

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

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

As explained, "ground truth" in the diagnostic sense is not directly applicable. For performance testing of a mechanical device like this, the "ground truth" would be established by standardized engineering and mechanical test methods to measure properties like pull-out strength, ultimate tensile strength, fatigue life, etc., comparing them against the known performance of the predicate devices. The document states "performance testing conducted demonstrates that the insertion and fixation properties... are substantially equivalent." This implies that standard mechanical tests were performed.

8. The sample size for the training set

There is no mention of a training set. This is a physical medical device, not a machine learning model, so the concept of a "training set" is not applicable in this context.

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

Not applicable as there is no training set mentioned or relevant for this device.

Summary

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Section 5. 510(k) Summary

510(k) Owner Pivot Medical Inc. 247 Humboldt Court Sunnyvale CA 94089 Phone: 408-774-1452 Fax: 408-739-4199 Jon Cook Director Regulatory Affairs and Quality Assurance

FDA Contact Jon Cook Director Regulatory Affairs and Quality Assurance Pivot Medical 247 Humboldt Court Sunnyvale CA 94089 Telephone: (408) 533-3081 Facsimile: (408) 739-4199 Email: icook@pivotmedical.com

Date Summary Prepared: February 16, 2011

Device Name

Trade Name: NanoTack Suture Anchor 1.4mm Common Name: Bone Anchor Classification Name: Smooth or threaded metallic bone fixation fastener Regulation number: 21 CFR888.3040 Product Code: MBI

Predicate Devices

Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586

Biomet Sleeve with ZipLoop™ Fixation Device - K080088 and K101063

Device Description

Intended Use

The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

Confidential

Page 1 of 2

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Image /page/1/Picture/1 description: The image shows the logo for Pivot Medical. The logo consists of the word "pivot" in a sans-serif font, with the "o" replaced by a stylized sphere. Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.

Summary of Technological Characteristics

The Pivot NanoTack Suture Anchor is substantially equivalent in design, materials, and function to the BioRaptor 2.3PK (K071586) and the Biomet Sleeve with ZipLoop (K080088 and K101063) predicate devices. The only difference between the NanoTack Suture Anchor and the BioRaptor 2.3PK is that the NanoTack utilizes a smaller size suture. The only difference between the NanoTack Suture Anchor and the Biomet Sleeve with ZipLoop is that the NanoTack anchor body is PEEK and the Biomet anchor body is polyester suture.

Summary of Performance Testing

The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors.

Summary of Substantial Equivalence

Based upon the indications for use, technological characteristics, and comparison to the predicate devices, the Pivot NanoTack Suture Anchor is substantially equivalent to predicate devices.

Confidential

Page 2 of 2

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

Pivot Medical Inc. % Mr. Jon Cook Director Regulatory Affairs and Quality Assurance 247 Humboldt Court Sunnyvale, California 94089

MAY 25 2011

Re: K110473

Trade/Device Name: NanoTack Suture Anchor 1.4mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 17, 2011 Received: May 19, 2011

Dear Mr. Cook:

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

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Page 2 - Mr. Jon Cook

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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E.S.Keith

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

Enclosure

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Pivot Medical

Indications for Use

510(k) Number (if-known): K110473

NanoTack Suture Anchor Device Name:

・

Indications for Use:

The NanoTack Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.

Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

El Kutt

(Division Sign-Off) (Division Sign-of-Surgical, Orthopedic, Divisionative Devices

510(k) Number K110473

Confidential

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.