The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Flat foot treatment in children and adolescents
Congenital flat foot
Non successful long term orthopaedic treatment (shoes, insoles ... )
Tarsal coalitions
Painfully flat foot
Supple deformity in posterior tibial tendon dysfunction
Paralytic flat foot
Subtalar instability

Device Description

The PIT'Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades. The PIT'Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT'Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges. The PIT'Stop implant should be removed: at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from 10mm to 17mm. Material: The PIT'Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560. Single use: The PIT'Stop® implant is designed for single use only. Sterilization: The PIT'Stop® implant is supplied sterile, using gamma irradiation.

AI/ML Overview

The provided text describes a medical device, the PIT'Stop® implant, and its substantial equivalence to predicate devices, but it does not contain information about studies proving the device meets acceptance criteria for an AI/ML powered device. The document is a 510(k) premarket notification for a traditional medical implant.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/ML device based on the given input. The categories you've asked for (such as test set sample size, ground truth establishment, MRMC studies, standalone performance, training set size) are relevant for AI/ML device evaluations, but they are not applicable to the information provided in this 510(k) submission for the PIT'Stop® implant.

The "Summary Performance Data" section does mention performance testing:

"Performance testing of the PIT'Stop® implant was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on PIT'Stop® implant. The results of the testing performed by the independent test laboratory indicate that the PIT'Stop® implant met the acceptance criteria."

This refers to mechanical engineering tests for an implant, not AI/ML performance evaluation.

Summary

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November 28, 2017 In2bones Sas % Norman Estrin Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906

Re: K170688

Trade/Device Name: PIT'Stop® implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 17, 2017 Received: October 23, 2017

Dear Norman Estrin:

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 (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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,

Vincent J. Devlin -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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Indications for Use

510(k) Number (if known) K170688

Device Name

PIT'Stop® implant

Indications for Use (Describe)

Flat foot treatment in children and adolescents
Congenital flat foot
Non successful long term orthopaedic treatment (shoes, insoles ... )
Tarsal coalitions
Painfully flat foot
Supple deformity in posterior tibial tendon dysfunction
Paralytic flat foot
Subtalar instability

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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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white curved line on the left side. The text "IN2BONES" is in white, with the "2" in orange.

For

Sponsor identification	In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29
Establishmentregistration number	3010470577
Date of preparation	October 13th, 2017
Contact person	Norman F. Estrin, Ph.D.Estrin Consulting Group LLC3100 N. Leisure World Blvd.Silver Spring, MD 20906Phone: 240-994-9999Email: estrin@yourFDAconsultant.com
Authorized Agent inthe United States	Norman F. Estrin, Ph.D.Estrin Consulting Group LLC3100 N. Leisure World Blvd.Silver Spring, MD 20906Phone: 240-994-9999Email: estrin@yourFDAconsultant.com
Proprietary Name	PIT'Stop® implant
Common name	Subtalar implant
Device classificationregulation	21 CFR 888. 3040: Smooth or threaded metallic bonefixation screw or fastenerClass II
Device ProductCode and Panel	HWC: screw, fixation, bone87 orthopedics
Device Description	The PIT'Stop® implant is a cannulated implant composed oftwo symmetrical and flattened sides, and small blades.The PIT'Stop® implant is designed to adequately maintainthe filling of the sinus tarsi, and is made of PEEK, a materialrecognized for its mechanical and radiolucent properties.The PIT'Stop® implant is introduced into the axis of sinustarsi, and its fixation is performed by anti-return flanges.The PIT'Stop implant should be removed:at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from10mm to 17mm.Material: The PIT'Stop® implant is made of PEEK accordingto standard ASTM F2026 and include markers made oftantalum according to ASTM F560.Single use: The PIT'Stop® implant is designed for single useonly.Sterilization: The PIT'Stop® implant is supplied sterile, usinggamma irradiation.
Predicate Devices	Newdeal KALIX® II Flat foot implant (K061765)Solana Surgical, LLC, Gaitway Implant System (K122738)In2Bones OS2®-VP varisation staple (K153770)
Indications for use:	The PIT'Stop® implant is indicated for use in the treatmentof the hyperpronated foot and stabilization of the subtalarjoint.It is designed to block forward, downward and medialdisplacement of the talus, thus allowing normal subtalar jointmotion but blocking excessive pronation and the resultingsequela.- Flat foot treatment in children and adolescents- Congenital flat foot- Non successful long term orthopaedic treatment (shoes,insoles...)- Tarsal coalitions- Painfully flat foot- Supple deformity in posterior tibial tendon dysfunction- Paralytic flat foot- Subtalar instability

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Comparison of theindications for usewith the predicatedevice:	The indications for use for the PIT'Stop® implant are identical tothe predicate devices Newdeal KALIX® II Flat foot implant(K061765), and Solana Surgical, LLC, Gaitway Implant System(K122738).
Comparison ofTechnologicalcharacteristics andSubstantialEquivalenceSummary:	The PIT'Stop® implant is similar to the predicate devices NewdealKALIX® II Flat foot implant (K061765) and Solana Surgical, LLC,Gaitway Implant System (K122738) in intended use, design, sizesand principles of operation, and is similar to the predicate deviceOS2®-VP Varisation staple (K153770) in material.
SummaryPerformance Data	Performance testing of the PIT'Stop® implant was assessed throughmechanical bench testing performed by an independent testlaboratory, animal and clinical testing being considered notapplicable.Testing performed included static and dynamic compression testson PIT'Stop® implant. The results of the testing performed by theindependent test laboratory indicate that the PIT'Stop® implant metthe acceptance criteria.
CONCLUSION	Based on the comparison of indications for use and technologicalcharacteristics and the results of the testing performed, thePIT'Stop® implant is substantially equivalent to the predicatedevices identified in the 510(k) submission.

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.