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MicroPort total hip systems are intended for use in total hip arthroplasty for relief of pain and/or improved hip function in skeletally mature patients.

Please refer to the Indications for Use forms 3881 for the indications for each included 510(k).

A change in ethylene oxide (EO) sterlization supplier is taking place, affecting MicroPort Orthopedics ceramic, ultra-high molecular weight polyethylene, polymethyl methacrylate, and UHMWPE/metal combinations. The subject devices consist of multiple devices across multiple systems. The subject devices are identical to the predicate devices in all aspects, and the only change is to the sterilization supplier and sterilization parameters. The subject devices include the following affected components:

· Metal shell inserts composed of utta-high polyethylene (UHMWPE) and vitamin E cross-inked polyethylene (VEXLPE)

· Distal cement spacer composed of polymethyl methacrylate (PMMA)

· Femoral heads composed of ceramic

• · Acetabular Liners composed of UHMWPE with Ti Bead X-ray markers, UHMWPE GUR 1020 XLPE, and GUR 1020 VEXLPE
• · Acetabular Cups composed of UHMWPE GUR 1050
• · Titanium Apical Hole Plug with a polyoxymethylene handle
• · Bipolar Heads composed of UHMWPE and cobalt chrome alloy
• · Centralizers composed of PMMA

The subject materials conform to the following standards:

• · UHMWPE GUR 1050, XLPE GUR 1020, and VEXLPE GUR 1020 conforming to ASTM F648
• · UHMWPE blended with Vitamin E conforming to ASTM F2695
• · Ceramic conforming to ISO 6474
• · Wrought titanium alloy conforming to ASTM F136
• · Polyoxymethylene conforming to ASTM D6778
• · Cobalt chrome alloy conforming to ASTM F75
• · Unalloyed titanium conforming to ASTM F67

The sterilization type and sterility assurance level are not affected by the change and remain identical. The current EO sterlization supplier and the new EO supplier use similar parameters in their EO sterilization cycles, and a comparison of the parameters can be found in the Ethylene Oxide Sterilization Report. The subject sterlization process underwent sterilization validation per standards ISO 11135:2014, ISO/TS 21387, and ISO 1099-7:2008 to demonstrate the new sterilize MPO products to a Sterlity Assurance level of 10^-6 or less. The sterilization shows that the new subject process is capable of achieving the same sterility performance compared to the process. The subject device pouch and blister packaging underwent validation testing per ISO 11607-1.2019, ISO 11607-2:2019, ASTM F1886, and ASTM F1829 to demonstrate the sterile barrier is capable of withstanding an increase of pressure rate. Furthermore, biocompatibility assessment of the subject material properties and device characteristics are unaffected by the subject modification.

This appears to be an FDA 510(k) summary for a change in an Ethylene Oxide (EO) sterilization supplier for a range of hip joint prostheses.

The request asks for information regarding acceptance criteria and a study proving a device meets these criteria, specifically mentioning elements related to AI/software validation (e.g., sample size for test set, expert ground truth, MRMC studies, standalone performance, training set details).

Based on the provided text, this document is not about a new medical device that requires clinical performance testing or AI/software validation. Instead, it details a change in a manufacturing process (specifically, a change in the sterilization supplier and parameters) for existing cleared devices. The regulatory pathway is a 510(k) for a manufacturing change, not for a novel device or AI/software.

Therefore, most of the requested information (like expert radiologists, MRMC studies, training sets, etc.) is not applicable to this type of submission.

Here's a breakdown of what is relevant and what is not:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The primary acceptance criterion here is maintaining a Sterility Assurance Level (SAL) of 10^-6 or less and demonstrating that the change does not affect the design, safety, or effectiveness of the devices. It also implicitly requires the packaging to maintain sterile barrier integrity.
• Reported Device Performance:
  • Sterilization validation per ISO 11135:2014, ISO/TS 21387, and ISO 1099-7:2008 demonstrated that the new sterilization process is "capable of achieving the same sterility performance" as the previous process, meeting the SAL of 10^-6 or less.
  • Packaging validation per ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886, and ASTM F1829 demonstrated the sterile barrier's capability.
  • Biocompatibility was assessed and determined to be unaffected.

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

• The document implies validation testing was performed on representative samples, but does not specify sample sizes for the sterilization or packaging validation tests.
• Data Provenance: Not explicitly stated, but it would be from the manufacturer's internal testing or contracted lab testing related to the new sterilization process and packaging. It would be prospective testing designed to validate the new process. Country of origin for data is not mentioned but typically would be where the manufacturing/testing takes place.

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

• Not applicable. This submission is not about clinical performance or AI/software. Ground truth in this context relates to validated physical/chemical properties (sterility, material integrity, packaging strength) rather than clinical expert interpretation. The "experts" would be qualified engineers and microbiologists conducting and interpreting the validation studies.

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

• Not applicable. This is a quality system/manufacturing process validation, not a clinical study requiring adjudication of expert interpretations.

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 is not an AI/software device.

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

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

7. The type of ground truth used:

• The "ground truth" here is established through industry-standard sterilization and packaging validation protocols (e.g., ISO 11135, ISO 11607, ASTM standards) that define acceptable levels of sterility and packaging integrity. This involves precise measurements and biological indicators, not expert consensus or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device; there is no "training set."

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

• Not applicable. As above, no training set is relevant here.

In summary: The provided text is a 510(k) notification for a manufacturing change (sterilization supplier), not for a new device that would involve the typical acceptance criteria and validation studies of an AI/software product or a novel medical device requiring clinical performance data. The "study" mentioned is the sterilization and packaging validation to ensure the hip prostheses remain safe and effective after the change in sterilization supplier.

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BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters.

The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.

This document is a 510(k) premarket notification for a medical device (BENCOX Delta Option Heads, a hip joint prosthesis component). It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document is NOT a study describing the performance of an AI/ML medical device. It details the engineering and material properties of a physical orthopedic implant. Therefore, the questions related to AI/ML device performance, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical (bench) testing performed to demonstrate the device's safety and effectiveness compared to predicate devices, rather than clinical performance or AI/ML algorithm validation.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria values and the device's reported performance against those criteria. It lists the types of non-clinical tests performed to demonstrate substantial equivalence. These tests are implicitly conducted against established engineering and material standards for orthopedic implants.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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

Not applicable. This is a physical orthopedic implant, not an AI/ML medical device.

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