The Femoral Trochanteric Nail System - Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur.

Device Description

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Femoral Trochanteric Nail System – Neonail consists of metal rods, bone screws, and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

AI/ML Overview

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The document is an FDA 510(k) clearance letter for a medical device (Femoral Trochanteric Nail System - Neonail), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's why I cannot fulfill your request completely:

No acceptance criteria are explicitly stated in a tabular format. The document describes a comparison to a predicate device to establish substantial equivalence, not a set of specific performance acceptance criteria for the new device.
The document states "Clinical data were not submitted in this premarket notification." This means there was no clinical study conducted on the device to prove it meets clinical acceptance criteria. Instead, the submission relies on non-clinical data (engineering analysis, dimensional analysis, and mechanical testing) to show substantial equivalence.

Therefore, I cannot provide information on:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set or data provenance for a clinical study.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
A multi-reader multi-case (MRMC) comparative effectiveness study.
A standalone performance study based on clinical data.
The type of ground truth used from a clinical study.
Sample size for a training set (as no AI/machine learning component is mentioned or evaluated).
How ground truth for a training set was established.

However, I can extract the following relevant information regarding the non-clinical data used for demonstrating substantial equivalence:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not in your requested format, the device's performance was evaluated against standards applicable to intramedullary fixation devices. The "acceptance criteria" here are implicitly meeting the requirements of these standards and demonstrating equivalence to the predicate device.

Acceptance Criteria (Implied by Standards and Substantial Equivalence Claim)	Reported Device Performance (Based on Non-Clinical Testing)
Conformance to ASTM F1264 for Intramedullary Fixation Devices: Static Four-Point Bending	The "worst case nail" was subjected to static four-point bending and the "worst case screws" to static four-point bending according to ASTM F1264. (Implied successful conformance for substantial equivalence).
Conformance to ASTM F1264 for Intramedullary Fixation Devices: Static Torsion	The "worst case nail" was subjected to static torsion according to ASTM F1264. (Implied successful conformance for substantial equivalence).
Conformance to ASTM F1264 for Intramedullary Fixation Devices: Bending Fatigue	The "worst case nail" was subjected to bending fatigue and the "worst case screws" to bending fatigue according to ASTM F1264. (Implied successful conformance for substantial equivalence).
Conformance to ASTM F384-17 for Metallic Angled Orthopedic Fracture Fixation Devices: Static Bending	The "worst case nail" was subjected to static bending according to ASTM F384-17. (Implied successful conformance for substantial equivalence).
Conformance to ASTM F384-17 for Metallic Angled Orthopedic Fracture Fixation Devices: Bending Fatigue	Tthe "worst case nail" was subjected to bending fatigue according to ASTM F384-17. (Implied successful conformance for substantial equivalence).
Conformance to ASTM F543 for Metallic Bone Screws: Torsional Properties, Driving Torque, Axial Pullout Strength, Self-Tapping Performance	The "worst case screws" were subjected to torsional properties, driving torque, axial pullout strength, and self-tapping performance according to ASTM F543. (Implied successful conformance for substantial equivalence).
Cut-out Resistance Performance (for Trochanteric Nail/Trochanteric Sliding Screw construct)	Cut-out testing was performed for the Trochanteric Nail/Trochanteric Sliding Screw construct based on the article by SOMMERS et al., 2004. (Implied successful conformance for substantial equivalence, specifically focusing on this critical mechanical aspect for trochanteric nails).
Substantial Equivalence to Predicate Device (K200869) in Indications, Design, Dimensions, Operating Principle, Materials, and Packaging	The submission claims the device has equivalent indications, design, dimensions, operating principle, basic design, materials, and similar packaging to the predicate device. Differences (lack of "U-Blade Lag Screw" and specific osteoporotic/osteopenic bone indication) were deemed not to raise new safety/effectiveness concerns, with the subject device's indications being a subset of the predicate's. This is the overarching "performance" demonstrated.

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

Test Set (Non-clinical): The document refers to "worst case nail" and "worst case screws" being subjected to testing. It doesn't specify the exact number of nails or screws tested beyond referencing "worst case." The data provenance is from non-clinical mechanical testing conducted by the manufacturer (Neoortho Produtos Ortopédicos SA). It is prospective in the sense that the tests were conducted specifically for this submission.

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

Not applicable. This information pertains to clinical studies, which were explicitly stated as "not submitted."

4. Adjudication Method for the Test Set:

Not applicable. This information pertains to retrospective clinical studies or expert consensus processes, neither of which were performed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study involves human readers interpreting cases, often with and without AI assistance, and was not performed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

No. This device is a physical medical implant, not an algorithm. The standalone performance refers to the device's mechanical integrity as tested against industry standards.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by engineering and mechanical testing standards (e.g., ASTM F1264, ASTM F384-17, ASTM F543) and a referenced scientific article for cut-out testing (SOMMERS et al., 2004). The "truth" is whether the device meets the physical requirements and behaviors defined by these standards.

8. The Sample Size for the Training Set:

Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is involved.

Summary

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December 6, 2022

Neoortho Produtos Ortopédicos S/A Luciane Suzuki Regulatory Affairs Rua Angelo Domingos Durigan, 607 , Cascatinha Curitiba, PR 82025-100 Brazil

Re: K221021

Trade/Device Name: Femoral Trochanteric Nail System - Neonail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 10, 2022 Received: October 11, 2022

Dear Luciane Suzuki:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ofpmn.cfm identifies.combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Victoria A. Lilling - Digital
.

Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221021

Device Name Femoral Trochanteric Nail System - Neonail

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Neoortho Produtos Ortopédicos SA

Femoral Trochanteric Nail System – Neonail

December 05, 2022

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Neoortho Produtos Ortopédicos SARua Ângelo Domingos Durigan, 607Curitiba, PR 82025-100BrazilOffice number: +55 41 3535 1033
Official Contact:	Luciane SuzukiRegulatory AffairsEmail: regulatorio@neoortho.com.br

Type of 510(k) Submission:	Traditional
Trade or Proprietary Name:	Femoral Trochanteric Nail System – Neonail
Common or Usual Name:	Rod, fixation, intramedullary and accessories
Classification Name	Intramedullary fixation rod
Regulation Number:	21 CFR 888.3020
Product Code:	HSB
Class of Device:	Class II
Panel:	Orthopedic Products Panel
Reason for Submission:	New device
Prior Related Submissions:	K151806
Multiple Devices:	None; this is the only device in the submission

DEVICE NAME AND CLASSIFICATION

INTENDED USE

Femoral Trochanteric Nail System - Neonail system is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved. It is intended for adults only.

INDICATIONS FOR USE

Device Name: Femoral Trochanteric Nail System - Neonail

The Femoral Trochanteric Nail System – Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur.

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The subject device Femoral Trochanteric Nail System - Neonail has the following differences regarding the INDICATIONS FOR USE when compared with the predicate device cleared in K200869:

. The subject device is not indicated in cases including osteoporotic and osteopenic bone;
. The subject device does not include a "U-Blade Lag Screw" to be indicated for rotationally unstable fractures.

However, the subject device indications for use are totally included in the indications of the predicate device, that is, the subject indications are an identical subset of the predicate indications. The differences are related to the additional "U-Blade Lag Screw" present only in the predicate system. The subject device is not intended to cover the functions of the predicate additional "U-Blade Lag Screw". Thus, the differences do not raise new concerns regarding the safety and effectiveness of the subject device.

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICE

510(k)	Manufacturer	Device Name	Predicate
K200869	Stryker Orthopaedics	Gamma®3 Nail System	Primary
K141103	Neoortho Produtos Ortopédicos	Intramedullary Nail and Screws - NEONAIL	Additional

Femoral Trochanteric Nail System - Neonail is substantially equivalent in indications, design, and dimensions to those cleared in K200869.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. The worst case nail for the Femoral Trochanteric Nail System - Neonail product list was subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending, static torsion, and bending fatigue) and ASTM F384-17 Standard Specifications and Test Metallic Angled Orthopedic Fracture Fixation Devices (static bending and bending fatigue). Cut-out testing was also performed for the Trochanteric Nail/Trochanteric Sliding Screw construct based on the article by SOMMERS et al., 2004 .

The worst case screws available in the Femoral Trochanteric Nail System – Neonail product list were subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending and

SOMMERS, M. B.; ROTH, C.; HALL, H.; KAM, B. C. C.; EHMKE, L. W.; KRIEG, J. C.; MADEY, S. M.; BOTTLANG, M. A Laboratory Model to Evaluate Cutout Resistance of Implants for Pertrochanteric Fracture Fixation. Journal of Orthopaedic Trauma, v. 18, n. 6, p. 361-368, 2004.

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bending fatigue) and ASTM F543 Standard Specification and Test Method for Metallic Bone Screws (torsional properties, driving torque, axial pullout strength, and self-tapping performance).

Clinical data were not submitted in this premarket notification.

The differences in technological characteristics between the subject and predicate devices are related to the additional "U-Blade Lag Screw" present only in the predicate system. However, the other components of both systems are substantially equivalent. The subject device is not intended to cover the functions of the predicate additional "U-Blade Lag Screw". Thus, any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, Femoral Trochanteric Nail System - Neonail is substantially equivalent to the predicate devices:

has the same intended use,
uses the same operating principle, ●
incorporates the same basic design,
incorporates the same materials, and
. has similar packaging.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.