(79 days)
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No
The summary describes a physical implant made of silicone elastomer and does not mention any software, algorithms, or data processing related to AI or ML.
Yes
The device is intended to treat thumb disabilities caused by various forms of arthritis, which is a therapeutic purpose.
No
Explanation: The device is an implant for treating thumb disabilities, not for diagnosing them. The "Intended Use" section describes conditions the device treats, not conditions it identifies or diagnoses.
No
The device description clearly states it is an "implant" made of "molded silicone elastomer," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Avanta Orthopaedics Trapezial Implant is a physical implant intended to be surgically placed in the trapezial bone of the wrist to treat arthritis. It does not involve the examination of specimens from the body.
Therefore, it falls under the category of a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
trapezial bone of the wrist
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
Dow Corning Corporation Silastic H.P. Trapezial Implant
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
510(k) SUMMAR Y
长964381
JAN 22 1997
Submitter's Name:
Avanta Orthopaedics 9369 Carroll Park Drive, Suite A San Diego, CA 92121 619-452-8580
Louise Focht November 1, 1996 Avanta Orthopaedics Trapezial Implant Trapezial Implant Dow Corning Corporation Silastic H.P. Trapezial Implant
Contact: Date of Preparation: Device Name: Common Name: Predicate Device:
Device Description:
The Avanta Orthopaedics Trapezial Implant is a device intended to be implanted in the trapezial bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.