The Fixion™ Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.

Device Description

The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.

The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid.
The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device.
The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector.
Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.

AI/ML Overview

The provided text describes the "Fixion Intramedullary Nailing System," a medical device for fixing long bone fractures. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the way envisioned by the prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement with AI).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with performance metrics.

Here's an analysis of why the requested information cannot be fully extracted and what is available:

The document provides details typical for a 510(k) submission, including:

Intended Use: Fixation of long bone fractures (humerus, femur, tibia).
Predicate Devices: Several existing intramedullary nails.
Performance Standards (for materials and mechanical testing): ASTM F138 (stainless steel), ASTM F1264 (4-point bending), ASTM F383 (torsional testing). These are material and mechanical integrity standards, not clinical performance acceptance criteria.
Substantial Equivalence: Claims equivalence in intended use, indications for use, materials (Stainless Steel 316L canulated design), and fixation mechanism (expansion of nail vs. distal locking mechanisms of predicates).
Testing mentioned: "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." However, no specific details on these studies, their methodology, acceptance criteria, or results are provided in this summary.

Therefore, I cannot populate the requested table and answer many of the questions as the document does not contain acceptance criteria related to a device's clinical performance (e.g., diagnostic accuracy, effectiveness in human-AI collaboration) or a study proving it meets such criteria.

The prompt seems to be expecting information typically found in submissions for AI/ML-driven diagnostic devices, which require studies to demonstrate performance against clinical endpoints or expert ground truth. This document is for a mechanical orthopedic implant.

If I were to interpret "acceptance criteria" very broadly as "meeting the requirements for market clearance," then the evidence is the FDA's 510(k) clearance itself, based on substantial equivalence. However, this doesn't align with the detailed performance metrics and study design questions in your request.

Based on the provided text, I can state the following:

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

Acceptance Criteria: The document mentions adherence to ASTM F138, ASTM F1264, and ASTM F383 for material and mechanical properties. The ultimate "acceptance" criteria for market clearance under 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, technology, and safety/effectiveness. No specific performance metrics (e.g., fracture healing rates, reduction in non-union) or acceptance thresholds for such metrics are provided.
Reported Device Performance: The document states, "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." It also claims mechanical equivalence to predicate devices ("equivalent in mechanical properties," "equivalent fixation"). Specific numerical performance data or results from these studies 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):

Not applicable / Not provided. The document refers to "in-vitro and animal studies" but gives no details on sample sizes, study design (retrospective/prospective), or data provenance. There's no mention of a "test set" in the context of clinical data or AI model evaluation.

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 / Not provided. This information is relevant for studies involving human interpretation or AI model validation against expert ground truth, which is not described here.

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

Not applicable / Not provided.

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 / Not provided. This device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided.

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

Not applicable / Not provided. For the in-vitro and animal studies mentioned, "ground truth" would likely refer to engineering measurements (e.g., stress/strain, torsion resistance) and animal outcomes (e.g., bone healing, implant stability), but no specifics are given.

8. The sample size for the training set:

Not applicable / Not provided. This concept (training set) is relevant for AI/ML models, not for an orthopedic implant described in this manner.

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

Not applicable / Not provided.

In summary, the provided document is a regulatory submission for a medical device (an intramedullary nailing system) focusing on demonstrating substantial equivalence to predicate devices, rather than a clinical study report with detailed performance metrics and acceptance criteria for a diagnostic or AI-driven aid.

Summary

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K 99 0 717

7.1

510(K) Summary

Disc-O-Tech Medical Technologies Fixion Intramedullary Nailing System

Company Name

Disc-O-Tech Medical Technologies, Inc. 3 Hasadnaot St. Herzlia Israel, 46728

Submitter's Name and Contact Person

Jonathan S. Kahan, Esq. 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: 202-637-5794 Fax: 202-637-5910

Date Prepared

February, 1999.

Trade/Proprietary Name

Fixion™ Intramedullary Nailing System

Classification Name

Intramedullary Fixation Rod 21 C.F.R. § 888.3020 Class II

3 1999

JUN

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Predicate Devices

· CINTOR Orthopedic Div's Aginsky Nail (K803106
· HOWMEDICA's Seidel Humeral Locking Nail (K883882, K924004, K925544, K931256)
SYNTHES's AO Universal Tibial and Femoral Nails (K914453, and K914371
· SYNTHES's AO Unreamed Humeral (UHN) Tibial (TNN) and Femoral (UFN) Nails (K933518, K932330, and K923580, respectively).

Performance Standards

No performance standards applicable to Intramedullary Nails have been established by the FDA. However, the following standards were used:

· Stainless steel 316L which is used to manufacture the Fixion™ Intramedullary Nailing System meets the requirements of ASTM F138 - Standard Specification for Stainless steel Bar and Wire for Surgical Implants.
· The 4 point bending mechanical testing was performed according to ASTM F 1264 - standard for mechanical performance considerations for intramedullary fixation devices.
· The torsional mechanical testing was performed according to ASTM F383 -Standard Practice for Static Bend and Torsion Testing of Intramedullary Rods.

Intended Use

The Fixion"M Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.

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System Description

The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.

· The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
· The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid.

The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device.

· The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector.
Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.

Substantial Equivalence

The Fixion™ Nail has the same intended use and substantially similar indications for use as the predicates, i.e., fixation of long bone fractures of the humerus, tibia, and femur.

The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies.

The Fixion™ Nail, like the Synthes Universal Tibial and Femoral Nails, is a Stainless Steel 316L canulated design. The cross section of the Fixion™ Nail is circular with reinforcement bars, which was found to be equivalent in mechanical properties to the circular cross section of the predicate devices.

With respect to fixation, the expansion of the Fixion™ Nail results in the attachment of the 4 reinforcement bars to the medullary canal wall, providing equivalent fixation to the distal mechanism of the Seidel Humeral locking nail, in which the nail distal end's three leaves are expanded and attached to the medullar canal wall.

The expansion of the Fixion nail with saline, which is a non-compressible biocompatible fluid, does not raise any safety concerns.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

2 1999 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jonathan s. Kahan, Esq. Hogan & Hartson, L.L.P. Representing Disc-O-Tech Medical Technologies, Inc. 555 Thirteenth Street, N.W. Washington, DC 20004

Re: к990717 Fixion™ Intramedullary Nail System Trade Name: Regulatory Class: II Product Code: HSB Dated: February 24, 1 ਰੇ ਰੇ ਰੋ March 4, 1999 Received:

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Jonathan s. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration chosers. (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

K990717 510(K) Number (if known): _

Device Name:

Fixion™ Intramedullary Nailing system

Indication for Use:

The Fixion™ Intramedullary Nailing system is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.

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

Concurrence of CDRH, Ofice of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices

510(k) Number:

Prescription Use (per 21 CFR 801.109)

Over the Counter

Use

livision of General Restorative De

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.