(147 days)
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis:
- · correction of functional deformity;
- · femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is indicated for cementless use.
The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.
This looks like a 510(k) summary for a medical device that does not involve AI. Therefore, most of the questions about acceptance criteria, study design, ground truth, and expert involvement are not applicable in the context of AI/ML devices.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The provided document describes a traditional medical device (hip implant) and does not specify quantitative acceptance criteria in the way you would expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly that the device performs equivalently to the predicates in non-clinical mechanical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to perform under expected conditions consistent with predicates in: | Device demonstrated ability to perform under expected conditions.All testing determined that the device is substantially equivalent to the predicate devices. |
| - Range of Motion Analysis | (Passed - Implicitly equivalent to predicates) |
| - Impingement Testing | (Passed - Implicitly equivalent to predicates) |
| - Push Out, Lever Out, and Torsional Strength | (Passed - Implicitly equivalent to predicates) |
| Pyrogen limit specifications met via Kinetic Chromogenic method | Pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device clearance did not involve clinical testing as stated: "Clinical Testing: Clinical testing was not required". Therefore, there is no "test set" of patient data in the context of an AI/ML study. The "testing" referred to is mechanical testing of the physical device components. The document does not specify sample sizes for these mechanical tests, nor is data provenance (country, retrospective/prospective) relevant here.
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, as no clinical testing or AI/ML ground truth was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing or AI/ML ground truth was established.
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 is a physical hip implant device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to predicate device performance under controlled laboratory conditions, rather than clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set
Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model to train.
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June 07, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K190057
Trade/Device Name: DJO Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, OQG Dated: January 10, 2019 Received: January 11, 2019
Dear Teffany Hutto:
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/cfpmn/pmn.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.
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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 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) K190057
Device Name DJO Acetabular System
Indications for Use (Describe)
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis:
- · correction of functional deformity;
- · femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is indicated for cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date: June 7, 2019
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com
| Product | Common Name | Classification | Product Code |
|---|---|---|---|
| DJO Acetabular System | Total Hip Implant | Class II | LPH, OQG |
| Product Code | Regulation and Classification Name |
|---|---|
| LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21CFR 888.3358 |
| OQG | Hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncementedper 21 CFR 888.3358 |
Description:
The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular ● necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. This device is indicated for cementless use.
Predicate Devices:
| System Name | Manufacturer | 510(k) Clearance |
|---|---|---|
| FMP Hemispherical Acetabular Shells | Encore Medical, L.P. | K072888 |
| FMP HXe+ Acetabular Liner | Encore Medical, L.P. | K130365 |
| FMP HXe+ Extended Acetabular Liner | Encore Medical, L.P. | K172651 |
| Cancellous Bone Screws | Encore Medical, L.P. | K931665 |
| G7 Acetabular System | Biomet | K121874 |
| Trident Acetabular System | Stryker | K040412 |
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Comparable Features to Predicate Device(s):
K190057 p. 2/2
Acetabular Cup: Materials, size offering, style offering, key material thickness, porous coating, outer diameter, internal surface finish, anti-rotation feature, number of internal scallops, dome thread plug, screw hole options, screw hole layout, packaging, sterilization, manufacturing process.
Acetabular Liner: Material, size offering, number of scallops, minimum wall thickness, wear, impingement, poly locking feature, surface finish, sterilization, packaging, manufacturing process.
Bone Screw: Thread form and diameter, screw lengths, self tapping screw tip, surface finish, drive feature, material, sterilization, packaging, manufacturing process.
Implant Relationship: ROM, jump distance, poly liner locking mechanism, poly liner collar, poly liner articulating surface, bone screw angulation, bone screw drill preparation, titanium dome plug cover
Key Differences in Subject Device to Predicate:
There are no key differences between the subject device and predicate devices.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Range of Motion Analysis
- Impingement Testing
- Push Out, Lever Out, and Torsional Strength
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.