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The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.

The Exeter® Hip is indicated for:

• noninflammatory 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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.

The provided document describes a 510(k) premarket notification for the "Exeter® Hip Stem" (K110290), a femoral component for total hip arthroplasty. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel effectiveness or safety through clinical trials. As such, the information you've requested regarding acceptance criteria and a study to prove the device meets those criteria, particularly in the context of AI/software performance metrics, does not directly apply to this type of medical device submission.

The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device has the same intended use, technological characteristics, and performs as well as (or better than) a legally marketed predicate device, without raising different questions of safety and effectiveness. The "study" proving this for a traditional orthopedic implant usually involves non-clinical (bench) testing, rather than human clinical trials or AI performance evaluations with ground truth.

However, I can extract the relevant information presented in the document pertaining to the equivalence demonstration and non-clinical testing.

Here's a breakdown based on the document, addressing your questions where applicable to a traditional hardware medical device 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implied by the performance of the predicate device and relevant ISO/ASTM standards for hip implants. The device needs to demonstrate comparable mechanical integrity and biocompatibility.

Explanation: In a 510(k) for an orthopedic implant, "acceptance criteria" are less about a single numerical threshold and more about demonstrating that the new device configuration (here, new head compatibilities) performs equivalently to the existing cleared device and predicate devices under relevant standard tests, and does not introduce new safety concerns. The "reported device performance" refers to the non-clinical tests performed to support this equivalence.

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

• Sample Size for Test Set: Not specified in the summary document. For mechanical testing of medical devices, sample sizes are typically determined by statistical rationale to ensure confidence in the results, but these specifics are not provided in the public summary. These are bench tests, not clinical data sets.
• Data Provenance: The data is derived from non-clinical (bench) testing performed by the manufacturer, Howmedica Osteonics Corp. Country of origin for data generation is not explicitly stated but would typically be in a controlled laboratory environment conforming to regulatory standards (e.g., in the US or a region with equivalent standards). The testing is prospective in the sense that it was specifically conducted for this 510(k) submission to establish new compatibilities.

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

This question is not applicable to this 510(k). "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical studies, particularly for AI/software devices. For a traditional orthopedic implant's non-clinical testing, the "ground truth" is typically defined by engineering specifications, validated test methods (e.g., ISO, ASTM standards), and established material properties, interpreted by qualified engineers and scientists. No external "experts" in the sense of clinical reviewers are used to establish ground truth for these bench tests; the data speaks for itself against the standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or experts when establishing ground truth for diagnostic accuracy in clinical evaluations, particularly for AI. For non-clinical bench testing, the results are quantitative and directly measured against predefined acceptance criteria or predicate device performance; there's no need for multi-reader adjudication.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is used to assess the change in human reader performance (e.g., diagnostic accuracy) when aided by an AI algorithm. This 510(k) is for a physical orthopedic implant, not an AI software device. Therefore, no MRMC study was performed, and there is no "effect size of how much human readers improve with AI vs without AI assistance."

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

No. This question is applicable to AI/software as a medical device (SaMD) where the algorithm performs a function independently. The Exeter® Hip Stem is a physical implant; thus, no standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

The "ground truth" for this submission's non-clinical testing is based on:

• Validated engineering standards: Primarily ISO (e.g., ISO 7206-10, ISO 7206-6) and ASTM (e.g., ASTM G 71-81) for mechanical testing and material compatibility.
• Performance of the predicate device: The established safety and effectiveness profile of the already-marketed Exeter V40 Hip System (K011623) and other listed predicate devices (e.g., Meridian TMZF Femoral Hip Stem - K972228, V40™ taper cobalt chrome alloy femoral heads, Universal Taper Biolox® Delta Ceramic heads with titanium alloy adaptor sleeve) serves as the benchmark for equivalence.
  The "ground truth" is not clinical outcomes, pathology, or expert consensus in this context, but rather adherence to engineering principles and demonstrated physical performance.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) does not involve machine learning or AI; it's for a physical medical implant.

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

This question is not applicable for the same reason as point 8. No training set was used or established.

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The Citation TMZF HA Stem is indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally it can be used in treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. It is also indicated for use in revision procedures where other treatments or devices have failed.

The Citation TMZF HA Stems are anatomic stems in a variety of lengths and distal diameters. The larger diameter stems have a rotated distal slot that contains distal flutes or grooves. This stem is intended for the reconstruction of the head and neck of the femoral joint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. The stems can be used with any currently available Howmedica Osteonics acetabular components and V40 Femoral Heads that can be mated with a 5° 40' BG taper. The Citation TMZF HA Stems will be fabricated from TMZF Alloy. The stems are coated with a CP Titanium plasma spray coating and Pure-Fix™ HA.

This 510(k) submission is for the Citation TMZF HA Stem, a femoral component for hip arthroplasty. The device is not an AI/ML powered device, therefore, many of the requested categories are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of device. The evaluation is based on comparative analysis with predicate devices and material/mechanical testing, not a clinical test set with patient data.

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

Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. Substantial equivalence is determined by regulatory bodies based on engineering and design principles, and comparison to existing legally marketed devices.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the sense of clinical data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, and an MRMC study is not relevant for the evaluation of a hip stem.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is regulatory in nature. It centers on:

• Substantial equivalence: Demonstrated by comparing the device's intended use, materials, design, and operational principles to legally marketed predicate devices.
• Mechanical performance: Demonstrated through laboratory testing (e.g., fatigue testing) to ensure the device meets safety and performance standards, particularly concerning the effect of the HA coating.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model or "training set" for physical medical devices of this nature.

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

Not applicable.

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