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The ICONACY I-Hip system is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthrius, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two screw holes to permit the use of screws for adjunct fixation. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The provided text describes a 510(k) submission for the ICONACY I-Hip System, a total hip replacement device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about device performance, study details, and ground truth establishment is not available in the provided text.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set or human subject data was used. The evaluation was based on nonclinical (bench) testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. No expert-established ground truth for a test set was used, as no clinical testing was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A multi-reader multi-case comparative effectiveness study was not performed. The submission explicitly states "Clinical Testing: Clinical testing was not required for determining substantial equivalency with the predicate devices."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was derived from nonclinical (bench) testing results (e.g., measurements of material properties, mechanical performance under various loads, wear rates) compared against established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing processes are informed by engineering principles and existing knowledge of predicate devices.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, there was no "training set" for an algorithm. The design and manufacturing relied on established engineering standards and performance data from predicate devices.

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The Orthopedic Source Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of: degenerative joint disease, including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.

Indications for Use:

• 1. noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;
• 4. revision procedures where other treatments or devices have failed; and,
• 5. treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This implant is intended for cementless use.

The Orthopedic Source stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is a collarless flat wedge-shaped implant that provides excellent durability and stability in a design that is relatively simple and predictable to implant. The use of a collarless designity the Orthopedic Source hip tends to allow for self seating of the implant and achievement of optimal rotational stability, immediately after implantation. The incorporation of standard and lateralized offset options provides the surgeon the ability to reconstruct a stable joint with proper leg length in virtually all patient anatomies. The Orthopedic Source Stem has a 135° rack shaft angle and a standard 12/14 Morse type taper is incorporated in to the geometry to receive modular heads. The proximal body is circumferentially coated with commercially pure titanium plasma spray. Femoral heads are manufactured from wrought CoCrMo alloy conforming to ASTM F799 and are available in 22m, 28mm and 32mm diameters and multiple neck lengths.

This document is a 510(k) summary for a premarket notification for a hip implant, specifically the Orthopedic Source Press-fit Hip. This is a medical device approval for a physical product and not a software device, therefore, the requested information about acceptance criteria and studies (test set, ground truth, expert involvement, etc.) is not applicable in the context of AI/software performance.

The document describes the device, its intended use, and compares its technological characteristics to a predicate device (Taperloc Hip). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified.

The "testing" mentioned in this document is in the context of mechanical engineering analysis for the hip implant's strength and durability, not for a software algorithm's performance.

Therefore, I cannot populate the table or provide details on the study types (MRMC, standalone), sample sizes for test/training sets, or methods for establishing ground truth, as these concepts are relevant to software/AI device evaluation and not to the mechanical device described in this 510(k) summary.

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The HA Taperloc® Porous Femoral Stem & HA Taperloc® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

The HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems are the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems.

The provided text is a 510(k) premarket notification for a medical device (HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems).

This document explicitly states there was NO clinical testing performed to establish substantial equivalence for this device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this document, as a clinical study was not conducted.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this was a 510(k) submission primarily relying on substantial equivalence to a predicate device, not performance against predefined clinical criteria.
• Reported Device Performance: No clinical performance data is reported as no clinical testing was performed. The non-clinical testing focused on mechanical properties and deemed the device substantially equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

• Not Applicable: No clinical test set was used because no clinical testing was performed.
• Non-Clinical Testing: "Mechanical Testing with an Engineering Justification" was performed, but specific sample sizes for these tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: No clinical test set and thus no ground truth established by experts for a clinical comparison. Mechanical testing would have involved engineers and a review by the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: No clinical test set.

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 prosthetic hip joint stem, not an AI-assisted diagnostic or imaging device. There was no MRMC study conducted, and no AI component is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This device is a prosthetic hip joint stem, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable: For the purposes of demonstrating substantial equivalence for this medical device, the "ground truth" was established through comparison of materials, design, sizing, and indications to a legally marketed predicate device (Taperloc® Femoral Stem K921301), and mechanical testing to ensure no new risks. No clinical ground truth (like pathology or outcomes data) was used in a clinical study.

8. The sample size for the training set:

• Not Applicable: No clinical study involving a training set was performed for this 510(k) submission.

9. How the ground truth for the training set was established:

• Not Applicable: No clinical study involving a training set was performed.

Summary of the basis for substantial equivalence for this device:

The "HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems" achieved substantial equivalence based on:

• Device Description: Being "the same as the predicate Taperloc® Femoral Stem (K921301), except for the additions of Hydroxyapatite Coating and additional sized femoral stems."
• Indications for Use: Being the same as the predicate device.
• Summary of Technologies: Materials, design, sizing, and indications are "similar or identical to the predicate devices."
• Non-Clinical Testing: "Mechanical Testing with an Engineering Justification determined that the HA Taperloc® Porous Femoral Stems & HA Taperloc® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."
• Lack of Clinical Testing: Explicitly stated, "No clinical testing was provided as a basis for substantial equivalence."

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