(58 days)
The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7. 8, 9 and 10mm, and one length, 25mm.
This is a 510(k) premarket notification for a medical device (Phantom Sof-Thread Soft Tissue Interference Screw), not an AI/ML software device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and training sets for AI/ML performance evaluation is not applicable and cannot be extracted from this document.
The document describes the device, its intended use, and establishes substantial equivalence to predicate devices based on design and mechanical testing in cadaver bone.
Here's a breakdown of the relevant information provided in the document, which pertains to traditional medical device clearance, not AI/ML:
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Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to legally marketed predicate devices. This is demonstrated by comparing design, materials, and mechanical performance.
- Reported Device Performance:
- Mechanical Testing: "Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew."
- Comparison to Predicate: The Phantom Sof-Thread Screw has comparable insertion torque and pull-out strength to the Linvatec BioScrew, which is a legally marketed device.
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Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of cases or subjects in a traditional clinical trial sense. The "mechanical testing in cadaver bone" implies a sample of cadaver bones and screws, but the specific number (e.g., how many screws, how many bones) is not provided.
- Data Provenance: The testing was conducted "in cadaver bone," indicating an ex vivo setting. Country of origin is not specified.
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Number of experts used to establish ground truth & qualifications: N/A for this type of device and study. Ground truth in this context is based on direct physical measurements of mechanical properties.
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Adjudication Method: N/A. No human interpretation requiring adjudication is involved.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device, nor is it a diagnostic device where human reader performance would be the primary endpoint.
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Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
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Type of ground truth used: For the mechanical testing, the ground truth is the direct physical measurement of "average insertion torque" and "pull-out strength" in cadaver bone.
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Sample size for the training set: Not applicable. There is no AI/ML model, hence no training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional surgical implant, not an AI/ML device. Therefore, most of the requested information regarding AI/ML performance evaluation is not present. The device demonstrated substantial equivalence through mechanical testing in cadaver bone comparing its performance (insertion torque and pull-out strength) to a legally marketed predicate device.
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SUMMARY OF SAFETY AND EFFECTIVENESS
APR - 3 1998
| NAME OF SPONSOR: | DePuy Inc.P.O. Box 988Warsaw, Indiana 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl HastingsManager, Regulatory Submissions |
| TRADE NAME: | DePuy OrthoTech Phantom™ Sof-Thread Soft TissueInterference Screw |
| COMMON NAME: | Interference Screw |
| CLASSIFICATION: | 888.3040 Smooth or threaded bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Hyloc Interference Screw, K955733Linvatec BioScrew Absorbable Interference Screw. |
DEVICE DESCRIPTION AND INTENDED USE:
The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7. 8, 9 and 10mm, and one length, 25mm. The Phantom Sof-Thread Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Hyloc Interference Screw (now called the Phantom Interference Screw) is a resorbable, cannulated or non-cannulated interference screw, manufactured from the same material as the Phantom Sof-Thread Screw (PLLA), available in diameters of 7, 8 and 9mm and in lengths of 15-30mm. It is intended to be used to provide interference fixation of the bone block in bonetendon-bone grafts used for ACL reconstruction. The major differences in design between the Phantom Sof-Thread Screw and the Phantom Interference Screw are the more rounded and widely spaced threads, the rounded edges on the driver end and the one larger diameter size of the Phantom Sof-Thread Screw.
The Linvatec BioScrew Absorbable Interference Screw is a resorbable, cannulated interference screw available in diameters of 7-9mm and lengths of 20-30mm. The BioScrew is manufactured from PLLA and is intended "to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction and for femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semitendinous, gracilis)".
Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Ms. Cheryl Hastings Manager, Regulatory Submissions DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive Warsaw, Indiana 46581-0988
Re: K980440
Trade Name: Phantom™ Sof-Thread Soft Tissue Interference Screw Regulatory Class: II Product Code: HWC and MAI Dated: February 3, 1998 Received: February 4, 1998
Dear Ms. Hastings:
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 (OS) 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 ... 124 mm 17 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.
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.
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Page 2 - Ms. Cheryl Hastings
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
sincerely yours,
a 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 Phantom Sof-Thread Soft Tissue Interference Screw
Indications for Use:
The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation
| Prescription Use(Per 21 CFR 801.100) | OR | Over-The-Counter Use |
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| ------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980440 |
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| --------------- | --------- |
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§ 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.