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The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular™ HA Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular HA Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty. The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex Modular HA stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, with an optional hydroxyapatite (HA) coating on top of the titanium coating. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The provided document is a 510(k) premarket notification for the Apex Modular™ HA Hip Stem. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

The 510(k) process for this type of medical device (hip prosthesis) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific quantitative acceptance criteria in the manner requested for AI/software devices. The "study" mentioned here is the comparison to predicate devices, and the "acceptance criteria" is essentially the demonstration of substantial equivalence.

Therefore, I cannot fulfill your request for a detailed table and description of the study and its parameters because the necessary information is not present in the provided text. The document focuses on regulatory approval through substantial equivalence, not on the quantitative performance validation typical for AI/software.

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The Apex K2™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• . Rheumatoid arthritis;
• Correction of functional deformity: .
• Congenital dislocation; .
• Revision procedures where other treatments or devices have failed; .
• . Femoral neck and trochanteric fractures of the proximal femur.

The Apex K2™ Hip Stem consists of a rectangular tapered stem, modular necks that connect to the proximal end of the stem, and the modular heads that connect to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex K2 Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex K2 stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular hip system. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, the same coating method used by the predicate Apex Modular hip stem. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The provided text describes a 510(k) premarket notification for the Apex K2™ Hip Stem, seeking to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with performance metrics. The information focuses on device description, intended use, and comparison to predicate devices. As such, the requested details regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not available in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative performance metrics for the Apex K2™ Hip Stem. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
• Sample size used for the test set and data provenance: No test set is described. The document pertains to a 510(k) submission, not a clinical study on the Apex K2™ Hip Stem with a specific test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set with corresponding ground truth is detailed.
• Adjudication method for the test set: Not applicable.
• 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 document is for a hip stem, not an AI or diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document indicates that "Performance testing of the modularity was completed as per the relevant FDA guidance documents" and "Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents." This suggests engineering and material testing were performed, but the specific acceptance criteria and results of these tests are not detailed in the provided text. The submission is primarily about establishing substantial equivalence through comparison of features and characteristics to existing predicate devices.

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The Apex Modular™ Acetabular Cup is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular™ Acetabular Cups are manufactured of titanium alloy, with a sintered bead porous coating (commercially pure titanium, irregular bead geometry). The liners are manufactured of ram extruded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or ceramic, 28 or 32 mm diameter, with various offsets.

The provided text is a 510(k) summary for the Apex Modular™ Acetabular Cup, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe acceptance criteria for a performance study or a study that proves the device meets specific acceptance criteria in the way typically required for AI/ML medical devices.

Instead, the provided document focuses on demonstrating substantial equivalence to existing predicate devices (DePuy Pinnacle™ Acetabular Cup and Wright Medical Lineage™ Acetabular Cup) based on design, materials, and intended use. The "study" mentioned is "Liner retention studies were performed on the Apex Modular liners as per the relevant FDA guidance documents," but no specific acceptance criteria, results, or details of the study itself are provided beyond this general statement.

Therefore, for many of your points, the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a detailed performance study with quantitative metrics, as one would expect for an AI/ML device. The assessment is primarily a comparison to predicate devices, asserting "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" here are inferred from the features compared against the predicate devices to establish substantial equivalence. The "reported device performance" is the statement that the Apex Modular Acetabular Cup meets or is similar to these features. The liner retention study is the only specific "study" mentioned, with the implied "acceptance criteria" being compliance with FDA guidance and "performance" being that such studies were conducted.

Additional Information (Based on the Provided Text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable / Not Provided. The document describes a comparison to predicate devices and mentions "liner retention studies," but does not detail sample sizes, data provenance, or whether test sets were used in the way one would for an AI/ML algorithm's performance evaluation.

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

• Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is not described in the document for the Apex Modular Acetabular Cup.

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

• Not Applicable / Not Provided.

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:

• No. An MRMC study is not mentioned as this device is a physical implant, not an AI diagnostic tool for human readers.

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

• Not Applicable / No. This refers to AI/ML algorithm performance, which is not relevant for this physical medical device.

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

• Not Applicable / Not Provided (for performance evaluation). The "truth" for this device's regulatory clearance is its substantial equivalence in design, materials, and intended use to existing legally marketed devices, and compliance with relevant guidance for mechanical testing (like liner retention).

8. The sample size for the training set:

• Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

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

• Not Applicable / Not Provided. This concept is not relevant to the clearance of this physical implant.

In summary: The provided document is a 510(k) summary for a physical medical device (an acetabular cup), which focuses on demonstrating substantial equivalence to existing predicate devices through comparison of design features, materials, and intended use, along with general statements about compliance with FDA guidance for certain mechanical tests. It does not contain the kind of detailed performance study information, acceptance criteria, or ground truth establishment typically associated with the evaluation of AI/ML software as a medical device.

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The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
• Rheumatoid arthritis; .
• Correction of functional deformity; .
• Congenital dislocation; .
• Revision procedures where other treatments or devices have failed; .
• Femoral neck and trochanteric fractures of the proximal femur. ●

The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).

The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Modular™ Alumina Femoral Head. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria in terms of clinical or diagnostic performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed devices (Smith & Nephew Biolox Alumina Ceramic Heads and Plus Orthopedics Biolox® forte Alumina Ceramic Heads) for regulatory approval. This is typically done by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

The only "testing" mentioned is:

• "Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document."

This refers to mechanical engineering tests to ensure the physical integrity and durability of the ceramic head, not studies related to diagnostic accuracy, clinical outcomes, or human reader performance.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.

Ask a specific question about this device

Ask a specific question about this device

The Apex Modular™ Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
• . Rheumatoid arthritis:
• Correction of functional deformity; .
• Congenital dislocation: .
• Revision procedures where other treatments or devices have failed; .
• . Femoral neck and trochanteric fractures of the proximal femur.

The Apex Modular Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty.
The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.

The provided document is a 510(k) summary for the Apex Modular™ Hip Stem, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document highlights the following:

• Intended Use: The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement for conditions like non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, congenital dislocation, revision procedures, and femoral neck and trochanteric fractures.
• Device Description: It consists of three modular components: a porous coated femoral stem, a modular neck, and a modular head. Materials are titanium alloy for stem and neck, and cobalt chromium alloy for the head. The proximal metaphyseal region of the femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray.
• Predicate Device Comparison: Substantial equivalence is claimed to the S-ROM® Femoral Stem and the Biomet Modular Hip System. The document includes a table comparing design features and materials.
• Performance Testing Mentioned: "Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File."

Missing Information:

The document does not provide:

• A table of acceptance criteria and reported device performance.
• Details of a specific study designed to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies.
• Standalone performance data.
• Type of ground truth used or how it was established.

This type of 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and that any differences do not raise new questions of safety and effectiveness, often supported by standard mechanical/material testing outlined in FDA guidance documents rather than clinical studies with human subjects.

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