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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 Excia Hip System is intended to replace a hip joint.

The device is intended for:

• patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
• Patients suffering from disability due to previous fusion
• Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.

The provided text describes the "Excia Total Hip System" and its clearance through the 510(k) premarket notification process by the FDA. This specific document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting de novo clinical study data to prove novel acceptance criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance directly.
• Sample sizes used for a test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) for this particular device's testing (as it relies on equivalence).
• Sample size for a training set or how its ground truth was established, because it is comparing to previously approved predicate devices, not training an AI algorithm.

Instead, the provided text indicates that the device met acceptance criteria by demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing.

Here's an overview of how the "acceptance criteria" are addressed in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (Demonstrated by Substantial Equivalence):

The acceptance criteria for the Excia Total Hip System are implicitly that it performs as safely and effectively as its predicate devices, as demonstrated by meeting relevant industry standards and guidance documents for orthopedic implants.

• Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement
• Metallic Plasma Sprayed Coatings on Orthopedic Implants
• "Mechanically Locked" Modular Implant Components
• Acetabular Cup Prostheses
• Femoral Stem Prostheses
• Ceramic Ball Hip Systems
• Ultrahigh Molecular Weight Polyethylene (UHMWPE)

These tests confirmed the device's mechanical integrity and performance characteristics are comparable to or meet the requirements established for substantially equivalent predicate devices. |
| Biocompatibility (Material safety) | Implied by the use of standard materials like CoCr, Ti, Ti plasma spray, UHMWPE, and PMMA, which are well-established in orthopedic implants and have documented biocompatibility. No specific new testing is detailed, but adherence to guidance documents suggests material safety was considered. |
| Clinical Indications for Use (Safety and Effectiveness for specific patient populations) | The indicated uses for the Excia Hip System (rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, etc.) are consistent with those of the predicate devices. The FDA's 510(k) clearance confirms substantial equivalence for these indications. |

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation and a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with human subjects.

• Sample Size Used for Test Set and Data Provenance: Not applicable in the context of this 510(k) summary, as it describes non-clinical testing against established standards and comparison to predicate devices, not a clinical test set from human data. The "test set" would consist of the device components themselves undergoing specified mechanical and material tests.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. Ground truth is established by engineering standards, material science, and the documented performance of predicate devices.
• Adjudication Method: Not applicable. Performance is measured against predetermined physical properties and regulatory standards.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a medical device (hip replacement system), not an AI algorithm requiring MRMC studies.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
• Type of Ground Truth Used: The ground truth is rooted in established engineering standards, material specifications, and the historical performance and regulatory clearance of the predicate devices. This includes mechanical properties, material composition, wear rates, and fixation attributes, as defined by the various guidance documents listed.
• Sample Size for Training Set: Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the Substantial Equivalence Claim:

Aesculap believes the Excia Total Hip System is substantially equivalent in design and performance to the following predicate devices:

• BiCONTACT Hip System (K040191)
• 36mm V40 Femoral Head Components (K022077)
• Alloclassic Zweymueller (K030373)
• SC Total Hip System (K031474)
• Smith & Nephew Hip System (K022902)
• Pinnacle Duofix HA Acetabular Cup (K031495)
• Trident Porous Ti Acetabular Component with Coating (K013475)

The FDA's clearance (K042344) indicates their agreement that the Excia Total Hip System is substantially equivalent to these predicate devices for its intended use. This substantial equivalence determination is the primary "proof" that the device meets the necessary safety and effectiveness criteria for market entry under the 510(k) pathway.

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