The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.

Device Description

The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.
The modification made on the I.B.S.TM osteosynthesis screw are:
I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:

Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;
Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:
Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:
Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically osteosynthesis screws. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving new efficacy or safety through clinical trials or comprehensive performance studies against acceptance criteria in the way AI/ML devices typically would.

Therefore, the requested information categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are largely not applicable in the context of this device type and the regulatory submission provided.

However, I can extract information related to the device's technical validation, which serves a similar purpose to "meeting acceptance criteria" in this context:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Device's mechanical behavior to be substantially equivalent to predicate devices.	Dimensional modifications were evaluated through comparison with predicate devices and analysis of impact on mechanical behavior based on standard ASTM F543.
Pyrogenicity: Device must meet pyrogen limit specifications.	Passed Limulus Amebocyte Lysate (LAL) test in accordance with ANSI/AAMI ST72:2011.
Material Equivalence: Material should be identical to predicate devices.	Manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM F136 standards, identical to predicate materials.
Design Equivalence: Similar design to predicate devices (cannulated, self-tapping, self-drilling, compression/neutralization).	Confirmed.
Size Range Equivalence: Comparable size range to predicate devices.	Confirmed, with length discrepancies of the I.B.S.™ osteosynthesis screw predicate (K131920) in comparison to the modified I.B.S.™ Osteosynthesis screws 6.5mm diameter specifically addressed and deemed not to impact safety/effectiveness.
Indications for Use Equivalence: Similar indications to predicate devices.	Confirmed (fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs, osteosynthesis requiring mono or bicortical compression).

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

This is not a study involving patient data or test sets in the typical sense of AI/ML device evaluation. The "test set" here refers to the physical devices undergoing mechanical testing and material analysis.
The document states, "No new bench testing was deemed required to assess the torsional properties, driving torque and axial pullout of the modified I.B.S.™ osteosynthesis screws." This implies that existing data or established properties from the predicate device (K131920) were leveraged, and the analysis focused on the impact of the modifications on these properties rather than re-testing a specific number of new screws for all properties.
The pyrogen test refers to "batch testing"; however, the specific sample size for LAL testing is not provided.
Data provenance regarding a specific country of origin or retrospective/prospective nature isn't applicable as it's primarily an engineering and material equivalence assessment against standards.

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)

Not applicable. The "ground truth" for this type of device is established by engineering standards (e.g., ASTM F543, ISO 5832-3, ASTM F136, ANSI/AAMI ST72:2011) and material science principles, not by human experts interpreting clinical data.

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

Not applicable. This is not a study requiring human adjudication for data interpretation. Adherence to standards is the primary method of verification.

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 is a medical device (screw), not an AI/ML diagnostic or assistive device that would involve human readers.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance and safety is rooted in engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM, ANSI/AAMI) that define the expected mechanical properties, material composition, and biocompatibility (e.g., pyrogenicity) for bone fixation screws. The demonstration of substantial equivalence relies on conforming to these established objective benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires ground truth for a training set.

Summary

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

In2Bones SAS % Dr. Norman Estrin

May 10, 2017

Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906

Re: K170594

Trade/Device Name: I.B.S. 110 osteosynthesis screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 18, 2017 Received: May 1, 2017

Dear Dr. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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" (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.

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.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170594

Device Name

I.B.S.TM osteosynthesis screws

Indications for Use (Describe)

The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:

The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
Osteosynthesis requiring a mono or bicortical compression

The size of the chosen screw should be adapted to the specific indications.

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.

510(k) Summary For In2Bones I.B.S.™ osteosynthesis screws device modification

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	May 7, 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 StatesI.B.S.TM 2.0Osteosynthesis Screw	Norman F. Estrin, Ph.D.Estrin Consulting Group LLC3100 N. Leisure World Blvd.Silver Spring, MD 20906Phone: 240-994-9999Email: estrin@yourFDAconsultant.com
Initial 510(k) number	K131920
Proprietary Name	I.B.S.TM osteosynthesis screws
Common name	Bone fixation screw
Device classificationregulation	21 CFR 888.3040: Smooth or threaded metallic bone fixationscrew or fastenerClass II
Device ProductCode and Panel	HWC: screw, fixation, bone87 orthopedics
Device Description	The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.The modification made on the I.B.S.TM osteosynthesis screw are:I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;- Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:- Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.
Predicate Devices	Compression design: SBI, Autofix (K052576) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920) Neutralization design: Acumed, Acutrak screws (K944330) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920)
Indications for use:	The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:- The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs- Osteosynthesis requiring a mono or bicortical compressionThe size of the chosen screw should be adapted to the specific indications.
Comparison ofTechnologicalcharacteristics	The technological characteristics of the modified I.B.S.TM osteosynthesis screws are equivalent to the characteristics of predicate devices in terms of design, size range, raw material. All these implants have the following features:- Insertion into bone: The modified I.B.S.TM osteosynthesis screws and all predicate devices are intended for surgical implantation into bone for longer than 30 days.- Design: Predicate devices have similar design as the modified I.B.S.TM osteosynthesis screws. They all are cannulated, self-tapping and self-drilling screws with either a compression or a neutralization design.- Indications for use: Predicate devices have equivalent indications for use as the modified I.B.S.TM Osteosynthesis screws in terms of fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs. These non-identical indications are equivalent and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.- Equivalent size range: Predicate devices have comparable size range of as the modified I.B.S.TM Osteosynthesis screws. The slightly difference of the predicates does not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.The length discrepancies of the I.B.S.TM osteosynthesis screw predicate (K131920) in comparison to the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter are the reason of this Special 510(k) submission and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter, as it is explained in the "Performance Testing" section.- Material: The modified I.B.S.TM osteosynthesis screws have identical raw material, when compared to the predicate: all are manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM F136 standards.
SubstantialEquivalenceSummary	As described above, the modified I.B.S.TM osteosynthesis screwshave similar technological characteristics when compared to thepredicate devices.
SummaryPerformanceData	The dimensional modifications between the unmodified I.B.S.TMosteosynthesis Screws, K131920, and the modified I.B.S.TMosteosynthesis Screws have been evaluated through dimensionalcomparison with predicate devices and analysis of the impact onmechanical behavior based on standard ASTM F543.This standard describes methods to assess the torque to failure,insertion torque, axial pullout strength, and self-tappingperformance of screws. No new bench testing was deemedrequired to assess the torsional properties, driving torque andaxial pullout of the modified I.B.S.TM osteosynthesis screws.Therefore, the subject device was demonstrated to be as safeand effective as the above predicates
Pyrogen testing	The method used to make the determination that the devicemeets pyrogen limit specification is the Limulus AmebocyteLysate (LAL) test in accordance with ANSI/AAMIST72:2011: Bacterial endotoxins – Test methods, routinemonitoring and alternative to batch testing.
CONCLUSION	Based on the evaluations and the results of the dimensionalcomparison performed, the design and indications of themodified I.B.S.TM osteosynthesis screws are substantiallyequivalent to the predicate devices identified in the 510(k)submission. No new materials or processes are used in thedevelopment of this implant.The modified I.B.S.TM osteosynthesis screws are acceptablefor the application.

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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.