(358 days)
Not Found
No
The summary describes a mechanical implant (acetabular cup) and its associated instrumentation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an "Acetabular Cup" intended for use in treating degenerative and inflammatory arthritis of the hip joint, trauma, and revision of failed hip arthroplasties, which indicates it provides therapy by replacing a damaged joint.
No
The device is an acetabular cup, which is an implant used in hip arthroplasty, not a tool for diagnosing medical conditions. Its intended use is for treatment of degenerative and inflammatory arthritis, trauma, and failed hip arthroplasties.
No
The device description clearly indicates it is a physical implant (Acetabular Cup) made of materials with specific dimensions and requires instrumentation for implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for treating conditions of the hip joint (degenerative and inflammatory arthritis, trauma, revision of failed hip arthroplasties). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a physical implant (acetabular cup) and associated instrumentation for surgical implantation. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace or repair a damaged hip joint.
N/A
Intended Use / Indications for Use
The ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application.
Product codes
Not Found
Device Description
The ATLAS® III Acetabular Cup is available in twelve (12) outer diameter (O.D.) sizes from 46 mm to 68 mm in two (2) mm increments. The polyethylene insert is available in four (4) possible inner diameter (I.D.) size options, 22.2 mm, 26 mm, 28 mm and 32 mm. The ATLAS® III Acetabular Cup instrumentation system is utilized for proper impaction of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
AP X961388
510(k) SUMMARY - ATLAS® III Acetabular Cup
| Submitter Name: | Fournitures Hospitalieres
Office Medico Chirurgical International |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 6 rue Nobel, Z.I de Kernevez
Quimper, France 29000 |
| Contact Person: | C. Rafaitin |
| Phone Number: | (+33) 98.55.68.95 |
| Fax Number: | (+33) 98.53.42.13 |
| Date Prepared: | April 9, 1996 |
| Device Trade Name: | ATLAS® III Acetabular Cup |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component,
Ultra High Molecular Weight Polyethylene |
| Predicate Devices: | Hydroxylapatite McCutchen Acetabular Cup
Dow Corning Wright
(K912452) |
| | Omnifit-HA Acetabular Cup
Osteonics Corp.
(K911728) |
| | Secure-Fit HA PSL Extra Acetabular
Component System
Osteonics Corp.
(K954023) |
| Device Description: | The ATLAS® III Acetabular Cup is available in
twelve (12) outer diameter (O.D.) sizes from 46 mm
to 68 mm in two (2) mm increments. The
polyethylene insert is available in four (4) possible
inner diameter (I.D.) size options, 22.2 mm, 26 mm,
28 mm and 32 mm. The ATLAS® III Acetabular
Cup instrumentation system is utilized for proper
impaction of the device. |
| Intended Use: | The ATLAS® III Acetabular Cup is intended for
use in degenerative and inflammatory arthritis
of the hip joint, trauma, and revision of
previously failed hip arthroplasties. The device
is designed for cementless application. |
년
1
| Device Technological Characteristics and Comparison to Predicate Devices: | The ATLAS® III Acetabular Cup design includes eight (8) axial screw holes, four (4) locking pegs for anchoring the device during impaction, one (1) dome hole for verifying impaction, and a two (2) millimeter slot which closes up after impaction to assist implant stability. The use of screws for implant stability is optional and determined by the surgeon at the time of impaction. The polyethylene insert is placed into the acetabular shell by the surgeon once the shell is successfully impacted. |
|---|---|
| Identified predicate devices have the same intended use and may incorporate some or all of the above described design features either alone or in combination. | |
| Performance Data: | Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence. |
| Conclusion: | The ATLAS® III Acetabular Cup is substantially equivalent to predicate devices in terms of intended use, safety and effectiveness. |
:
II
1.000