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The DePuy Profile Femoral Hip with Porocoat prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

The DePuy Profile® Hip with Porocoat® prosthesis is identical in design and materials to the DePuy Profile® Hip with Porocoat® prosthesis cleared by FDA for cemented use (K872776). The prosthesis is designed with an anatomical conformance to the medullary canal, proximal porous-coating, rounded distal taper, and 12/14 femoral neck taper which allows for the use of interchangeable modular femoral heads. The prosthesis is available in six sizes, each are available in right and left configurations.

This 510(k) premarket notification is for a medical device, specifically a hip prosthesis. The acceptance criteria and supporting study details for such devices typically focus on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through design, material, and intended use comparisons, as well as biocompatibility and mechanical testing. It's important to note that this submission does not describe a study involving an AI algorithm or performance metrics like sensitivity, specificity, or reader studies with human-in-the-loop. Instead, the "study" is a comparison and verification of physical device properties.

Here's a breakdown of the requested information based on the provided text, adapted for a medical device submission that is not an AI/software device:

Acceptance Criteria and Device Performance (for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria are generally demonstrated by showing sameness or equivalence to established predicate devices in crucial aspects that ensure safety and effectiveness. The "performance" is the device meeting these equivalence criteria.

• DePuy Stability Hip (K934457) for uncemented use.
• DePuy Profile® Femoral Hip with Porocoat® (K872776) for cemented use. |
  | Stem Material | Ti-6Al-4V alloy, conforming to ASTM F-620 | Identical to:
• All listed predicate devices (K934457, K872776, K910156, K850055). |
  | Proximal Surface Coating | Porocoat® Porous-coating | Identical/Similar to:
• DePuy Stability Hip (K934457) and DePuy Profile® Porocoat® (K872776). Different from Hydroxyapatite (K910156) or None (K850055) but justified by equivalence to Porocoat® predicates. |
  | Design (Anatomical) | Anatomical conformance to medullary canal, rounded distal taper | Identical to:
• All listed predicate devices (K934457, K872776, K910156, K850055). |
  | Modular Heads | Yes | Identical to:
• All listed predicate devices (K934457, K872776, K910156, K850055). |
  | Modular Taper | 12/14mm | Identical to:
• All listed predicate devices (K934457, K872776, K910156, K850055). |
  | Manufacturing Process | Unchanged from previously cleared DePuy Profile® Hip with Porocoat® (K872776) | Identical to:
• DePuy Profile® Hip with Porocoat® (K872776). |

2. Sample Size for the Test Set and Data Provenance

• Test Set Description: Not applicable in the conventional sense for an AI device. The "test set" here would refer to the characteristics and specifications of the device itself and its components.
• Sample Size: This submission does not refer to sample sizes of patient data or clinical images for testing an algorithm. Instead, it would involve testing of physical device samples for mechanical properties, material composition, and coating adherence, but specific "sample sizes" for these tests are not detailed in this summary.
• Data Provenance: Not applicable for an AI device. The provenance related to this device would be its manufacturing origin (DePuy Orthopaedics, Inc., Warsaw, Indiana, USA). The basis of substantial equivalence relies on existing FDA-cleared devices, implying their performance data (which is not detailed here) supports the equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable as this is not an AI/software device requiring ground truth established by clinical experts for classification or diagnosis. The "ground truth" for a physical device is its adherence to material standards, design specifications, and mechanical performance, typically verified by engineers and material scientists.

4. Adjudication Method for the Test Set

• Not applicable as this is not an AI/software device. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance. This submission does not involve an AI component.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is not an AI/software device.

7. Type of Ground Truth Used

• Not applicable in the context of an AI device. For this physical device, the "ground truth" for its safety and effectiveness is established by:
  • Material specifications: Conformance to ASTM F-620 for Ti-6Al-4V alloy.
  • Design specifications: Conformance to established anatomical and modular head designs of predicate devices.
  • Manufacturing process control: Ensuring the process is identical or equivalent to previously cleared devices.
  • Intended use alignment: Matching the specified indications for use with predicate devices.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/software device, so there is no "training set" in the machine learning sense. The "training" for such a device is the established design, manufacturing processes, and materials, which have been refined over multiple generations of products and backed by extensive engineering and clinical experience with predicate devices.

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

• Not applicable. There is no training set. The "ground truth" for the predicate devices was established through a combination of engineering design principles, material science, mechanical testing, biocompatibility testing, animal studies (if applicable), and post-market surveillance and clinical experience over time that led to their initial FDA clearance. This submission leverages the established safety and effectiveness profile of these predicates.

Summary of the "Study" for K984459:

The "study" presented in this 510(k) is a comparison-based substantial equivalence justification. It's not a clinical trial or performance study with patients, but rather a detailed analysis demonstrating that the new device, DePuy Profile® Femoral Hip with Porocoat®, is sufficiently similar in design, materials, and intended use to existing FDA-cleared predicate devices to be considered safe and effective for its expanded indication (uncemented use).

The submission relies on a table-based comparison of key attributes (Intended Use, Stem Material, Proximal Surface Coating, Design, Modular Heads, Modular Taper) against four predicate devices (K934457, K872776, K910156, K850055). The acceptance criteria are implicitly met when the device's attributes are demonstrated to be identical or sufficiently similar to those of the legally marketed predicate devices, thereby leveraging the predicate devices' established safety and effectiveness.

No AI components, algorithms, or associated performance metrics like sensitivity/specificity are mentioned or evaluated in this submission.

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