(63 days)
The Fixion® MH System is intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of:
- Femoral head and/or neck fractures or non-unions;
- Aseptic necrosis of the femoral head and/or neck;
- Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with minimal acetabular involvement.
The Fixion® MH System is a modular hemi-hip system, which consist of the following main components:
- Implants (stainless steel), including the stem and head ball. The stem is the femoral diaphyseal component. It consists of an expandable stem body and a neck part. The unipolar head ball is the prosthesis hip component that articulates within the acetabulum.
- The Instrumentation Set is a set of accessories, including pre-operative tools, femoral canal preparation tools and accessories such as the stem insertion handle, inflation adapter, screwdriver for stem cap insertion and devices for implant removal.
- The Inflation Device is a pump, which rotation of its handle delivers saline into the stem. This action causes the expansion of the stem and its abutment to the bone medullary cavity. The pump pressure gauge indicates the inflation pressure.
The provided text describes the Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) and its acceptance for market, primarily through establishing substantial equivalence to predicate devices and adherence to relevant performance standards. It does not contain information about a study with acceptance criteria in terms of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with AI/ML device evaluations. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided.
However, I can extract the acceptance criteria related to material and mechanical performance standards, which are a form of "acceptance criteria" for a medical device of this type.
Here's the information gleaned from the text as per your request, focusing on the available context:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Fixion® MH System are primarily met through adherence to established international and national standards for orthopedic implants, and demonstration of substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that the device meets these standards and is substantially equivalent.
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| ISO 7206-1 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions. | The device's dimensions (10/16 mm stem body, 12 mm stem neck) are described. The submission implies compliance with this standard for classification and dimensional description. The dimensions are also stated to be "within the range of sizes of other cleared, marketed systems." |
| ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components. | Implied to have met the endurance properties outlined in this standard. The "Substantial Equivalence" section states the added components are made of the same materials and have the same basic design and operating principles as previously cleared devices, suggesting similar endurance performance. |
| ISO 7206-8 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion. | Implied to have met the endurance performance under torsion as per this standard. Similar to ISO 7206-4, substantial equivalence to predicate devices (with same materials, design, operating principles) supports this. |
| Guidance Document for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995. | Compliance with relevant FDA guidance for femoral stem prostheses. |
| Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995. | Compliance with relevant FDA guidance for modular implant components. The Fixion MH is described as a modular system with components like the stem and head ball. |
| ASTM F138-2000: Standard Specification for Stainless Steel Bar and Wire for Surgical Implants. | The implants (stem and head ball) are made of 316L stainless steel. This indicates compliance with material specifications for surgical implants. |
| ASTM F565-2000: Standard Practice for Care and Handling of Orthopedic Implants and Instruments. | Implied compliance with standard practices for care and handling, which would be part of the product's instructions for use and manufacturing processes. |
| Substantial Equivalence to Predicate Devices (K014072 and K010988, K012967): Same intended use, indications, basic design, operating principles, fixation method, packaging, sterilization, and materials. | The Fixion® MH 10/16 stem and 316L stainless steel head balls are explicitly stated to be substantially equivalent to cleared components of the Fixion® MH System (K014072) due to sharing these characteristics. This is the core "performance" assessment presented for this 510(k) submission. |
2. Sample size used for the test set and the data provenance
Not applicable. This submission relies on "substantial equivalence" to predicate devices and compliance with engineering standards, not on a clinical or performance study with a test set of data in the AI/ML sense. Data for engineering tests (e.g., endurance) would be laboratory-generated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's acceptance is its physical and mechanical properties as defined by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a physical hip implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this device's acceptance includes:
- Engineering Standards: Defined mechanical properties, material composition, and performance under specific test conditions (e.g., fatigue, torsion) as outlined in ISO and ASTM standards.
- Predicate Device Performance: The established safety and effectiveness record of the legally marketed predicate devices, to which this device is deemed substantially equivalent.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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MAY 3 0 2003
Disc-O-Tech Medical Technologies, Ltd. Fixion® Unipolar Modular Hemi-Hip System
510(K) Summary
KO30972
Disc-O-Tech Medical Technologies Ltd. Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) -10/16 mm stem body; 12 mm stem neck; 316L stainless steel head ball.
Company Name and Address
Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot St. Herzelia 46728 Israel
Submitter's Name and Contact Person
Hila Wachsler-Avrahami Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot St. Herzelia 46728 Israel Tel .: + 972 9 9511511 Fax .: + 972 9 9548939
Date Prepared
March 26, 2003
Trade/Proprietary Name
Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH)
Classification Name
Prosthesis, Hip, Hemi-, Femoral, Metal 21 CFR § 888.3360 Class II
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Predicate Devices
-
- Fixion® Unipolar Modular Hemi-Hip System (K014072) by Disc-O-Tech.
Performance Standards
The following standards were used:
-
- ISO 7206-1 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 1: Classification and Description of Dimensions.
-
- ISO 7206-4 (Draft, 1999): Implants for Surgery Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties of Stemmed Femoral Components.
-
- ISO 7206-8 (1995): Implants for Surgery Partial and Total Hip Joint Prostheses = Part 8: Endurance Performance of Stemmed Femoral Components with Application of Torsion.
-
- Guidance Document for Femoral Stem Prostheses (Draft), ORDB/DGRD/CDRH/FDA, August 1, 1995.
-
- Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components (Draft), ORDB/DGRD/CDRH/FDA, May 1, 1995.
-
- ASTM F138-2000: Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
-
- ASTM F565-2000: Standard Practice for Care and Handling of Orthopedic Implants and Instruments.
Intended Use
The Fixion® MH System is intended for cemented or non-cemented use as a hemi-hip replacement. It is indicated for use in cases of:
-
Femoral head and/or neck fractures or non-unions;
- Aseptic necrosis of the femoral head and/or neck; A
- Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with A minimal acetabular involvement.
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System Description
The Fixion® MH System is a modular hemi-hip system, which consist of the following main components:
- Implants (stainless steel), including the stem and head ball. The stem is the 1. femoral diaphyseal component. It consists of an expandable stem body and a neck part. The unipolar head ball is the prosthesis hip component that articulates within the acetabulum.
- The Instrumentation Set is a set of accessories, including pre-operative 2. tools, femoral canal preparation tools and accessories such as the stem insertion handle, inflation adapter, screwdriver for stem cap insertion and devices for implant removal.
- The Inflation Device is a pump, which rotation of its handle delivers saline 3. into the stem. This action causes the expansion of the stem and its abutment to the bone medullary cavity. The pump pressure gauge indicates the inflation pressure.
Substantial Equivalence
The Fixion® MH 10/16 stem (with a neck width of 12 mm) and the Fixion® MH 316L stainless steel head balls are substantially equivalent to the cleared stem and head balls of the Fixion® MH System (K014072):
- They have the same intended use and indications for use; ું.
- ું જ They incorporate the same basic design;
- They have the same operating principles; જુન
- ું જ They have the same fixation method;
- ું જ They are packed and sterilized using the same materials and processes.
The added components are made of the same materials as the cleared Fixion® MH stem.
In addition, the dimensions of the added Fixion® MH stem body, neck and head balls are within the range of sizes of other cleared, marketed systems.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Ms. Hila Wachsler-Avrahami Regulatory Affairs Disc-O-Tech Medical Technologies Ltd. 3 Hasadnaot Street Herzelia Israel 46728
Re: K030972
Trade/Device Name: Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH) Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: KWL Dated: April 29, 2003 Received: May 1, 2003
Dear Ms. Wachsler-Avrahami:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Lori Glastetter
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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliman
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known): _ Ko3 o972
Device Name: Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH)
Indication for Use: The Fixion® MH System intended for cemented or noncemented use as a hemi-hip replacement. It is indicated for use in cases of:
- Femoral head and/or neck fractures or non-unions; A
- Aseptic necrosis of the femoral head and/or neck; A
- 八 Osteo-, Rheumatoid-, and/or Post-traumatic arthritis of the hip, with minimal acetabular involvement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over the Counter Use |
|---|---|---|
| (per 21 CFR 801.109) |
[Signature]
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K030972 |
|---|---|
| --------------- | --------- |
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.