(70 days)
The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weightbearing and against more than sedentary activity; and arthrodesis of the hip.
The UltiMax Haig II Nail System is manufactured from titanium (6AI-4V ELI) per ASTM F136 and is light weight. The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), and is available in 130 ° 135 ° 140 ° 145 ° and 150 ° angles. These are manufactured and tested per ASTM specifications F787. The bone screw hole pattern is offset and 5.0mm cortical screws are used. The most proximal hole accepts a large diameter (7.0mm) cannulated screw. The plates are available in 3 hole, 5 hole, 6 hole, 8 hole, 10 hole, 12 hole and 14 hole lengths. The UltiMax Haig II Nails are available in 65-125mm (5 mm increments) lengths. The nails are tri-flanged with a series of holes in the proximal end. These holes serve as an enhancement to cement delivery. The Haig II Nail is implanted by direct impaction. Once implanted an adaptor is threaded on the distal end of the nail. A syringe containing a low viscosity bone cement is inserted into the adaptor and cement is delivered into the nail. The cement is pushed through the holes in the proximal end of the nail and dispersed into the femoral head.
The provided text describes a medical device, the UltiMax Haig II Nail System, and its clearance for market by the FDA. However, it does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for an AI/ML device.
The "Test Results" section is very brief and refers to mechanical testing, not performance related to a diagnostic or predictive algorithm. There is no mention of an algorithm, AI, or machine learning in the provided documents.
Therefore, many of the requested fields cannot be filled. I will answer based on the information available related to the device's clearance.
Acceptance Criteria and Device Performance for the UltiMax Haig II Nail System
The provided documentation does not detail "acceptance criteria" and "reported device performance" in the context of a typical AI/ML study, as the device in question is a physical orthopedic implant. The "acceptance criteria" here refer to its mechanical and material compliance with established ASTM standards for metallic nail-plate appliances, and its substantial equivalence to predicate devices for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from provided text) | Reported Device Performance (Summary from provided text) |
|---|---|---|
| Material Compliance | Manufactured from titanium (6AI-4V ELI) per ASTM F136 | Device manufactured from titanium (6AI-4V ELI) per ASTM F136 |
| Design/Manufacture | Barrel and plate (keyed and non-keyed) as one solid piece, available in specified angles (130°, 135°, 140°, 145°, 150°). Bone screw hole pattern offset, 5.0mm cortical screws used, 7.0mm cannulated screw for most proximal hole. Plates available in 3, 5, 6, 8, 10, 12, 14 hole lengths. Nails available in 65-125mm (5 mm increments) lengths. Nails tri-flanged with holes for cement delivery. | Design confirmed as specified. "Manufactured and tested per ASTM specifications F787." |
| Mechanical Strength/Durability | Meets ASTM test standards for metallic nail-plate appliances (F787). | "Test results proved the device to be of sound design" based on ASTM F787 testing. |
| Substantial Equivalence | Comparable features to predicate devices in materials, intended uses, design, testing, and manufacturing. | "The UltiMax Haig II Nail System is equivalent to the referenced legally marketed comparison devices." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the mechanical testing. The document states "The UltiMax Haig II Nail System has been tested..." but does not quantify how many units were tested.
- Data Provenance: The testing was conducted by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida, USA. This is a prospective test specifically for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an orthopedic implant, and its "ground truth" is based on objective mechanical properties and material composition, measured against established engineering standards (ASTM F787, F136). It does not involve expert interpretation or diagnosis for "ground truth."
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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. No AI/ML component is mentioned for this medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No AI/ML component is mentioned for this medical device.
7. The type of ground truth used
For this physical device, the "ground truth" is objective, quantifiable mechanical performance and material properties as defined by ASTM standards, along with a comparison of its design functionality to predicate devices. It is based on engineering standards and direct physical measurement.
8. The sample size for the training set
Not applicable. There is no AI/ML component and thus no "training set."
9. How the ground truth for the training set was established
Not applicable as there is no training set mentioned.
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Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: UltiMax Haig II Nail System
Common Name: Compression Hip/Supracondylar Screw
Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (Product Code 87LXT)
The UltiMax Haig II Nail System is manufactured from titanium (6AI-4V Device Description: ELI) per ASTM F136 and is light weight. Drawings are provided in Exhibit II.
The barrel and plate (keyed and non-keyed) are one solid piece (non-modular), and is available in 130 ° 135 ° 140 ° 145 ° and 150 ° angles. These are manufactured and tested per ASTM specifications F787. The bone screw hole pattern is offset and 5.0mm cortical screws are used. The most proximal hole accepts a large diameter (7.0mm) cannulated screw. The plates are available in 3 hole, 5 hole, 6 hole, 8 hole, 10 hole, 12 hole and 14 hole lengths.
The UltiMax Haig II Nails are available in 65-125mm (5 mm increments) lengths. The nails are tri-flanged with a series of holes in the proximal end. These holes serve as an enhancement to cement delivery. The Haig II Nail is implanted by direct impaction. Once implanted an adaptor is threaded on the distal end of the nail. A syringe containing a low viscosity bone cement is inserted into the adaptor and cement is delivered into the nail. The cement is pushed through the holes in the proximal end of the nail and dispersed into the femoral head.
Intended Use:. The Haig Nail system is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weightbearing and against more than sedentary activity; and arthrodesis of the hip.
Comparable Features to Predicate Device(s): Based on the materials, intended uses, design, testing, and manufacturing, the UltiMax Haig II Nail System is equivalent to the referenced legally marketed comparison devices.
Test Results: The UltiMax Haig II Nail System has been tested by the University of Miami Biomechanics Laboratory at Mount Sinai in Miami Beach, Florida. Based upon ASTM test standards for metallic nail-plate applicances (F787), test results proved the device to be of sound design.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Ms. Debbie De Los Santos Regulatory and Clinical Specialist Encore Orthopedics, Incorporated 9800 Metric Boulevard Austin. Texas 78758
Re: K991889 Trade Name: UltiMax Haig II Nail System Regulatory Class: II Product Code: LXT Dated: June 2, 1999 Received: June 3, 1999
Dear Ms. De Los Santos:
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 control provisions of the Act. The general control 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 action. In addition, FDA may publish further announcements 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 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding 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 regulation (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 premarket notification" (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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510(k) Number (if known):
Device Name:
Indications For Use:
UltiMax Haig II Nail System Indications For Use
The UltiMax Haig II Nail System is indicated for single use to stabilize intracapsular fractures of the neck of the femur; class I, class II, class III, and class IV trochanteric and subtrocanteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity, and arthrodesis of the hip.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_
biolley
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K991889
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.