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Bencox M Stem (Bencox Hip System) is intended for Cementless use in partial or total 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 trochantric 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 ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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 Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Bencox M Stem (Bencox Hip System) - Sterile
The Bencox M Stem is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head and used with Bencox Acetabular Cups cleared under K103431, K112019, K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

Bencox M Stem is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials used in subject device, Bencox M Stem, have been cleared for use in K112019 & K150007 for Bencox ID Stem & Bencox ID Stem (offset). The stem has a tapered rectangular section. The stem has a neck with a standard 12/14 conical taper to couple to Bencox Femoral Heads which have been cleared earlier. The Bencox M Stem is available 13 sizes with CCD angle of 132°. The stem is available in 13 sizes.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile
Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

The deformable centralizer is made of PMMA with flexible wing like projections that extend outwards from the base of the centralizer and fits over the outside diameter of the stem tip. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal. The hollow centralizer is designed to allow stem to engage distally within the cement mantle, subjecting the cement to compressive loading, and reducing end bearing of the stem directly onto the cement. The centralizer is a molded acrylic device manufactured from PMMA.

Bencox bone plug has a double flanged geometry very similar to the predicate devices. The plug blocks the propagation of the doughy bone cement downward in the medullary cavity. The proximal flange provides a proximal barrier, while the more flexible distal flange forms a secondary seal to prevent cement leakage. Bencox bone plug is manufactured from UHMWPE.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

Accessory BENCOX Hip Instrumentation: (Non Sterile)
The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons.

The parts of the instruments are made of stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

Bencox Hip System Instrumentation to be used Bencox M Stem (Bencox Hip System) & Bencox ID Cemented Stem is same with Instrumentation cleared under K103431, K112019, K120924 & K122099 along with the inclusion of instruments specific to Bencox M Stem such as Rasp, Impactor etc.

The provided text is a 510(k) summary for the Bencox M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug. This document describes a medical device and its equivalence to previously approved predicate devices, primarily based on non-clinical performance data. It does not describe a study involving patient data, ground truth establishment, or clinical performance metrics in the way your request outlines for AI/software-based devices.

Therefore, for the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, the information is not applicable or not available within this document because it pertains to a different type of device evaluation (hardware instead of software/AI).

However, I can extract the relevant performance data based on the non-clinical testing conducted for this orthopedic implant.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an orthopedic implant, the "acceptance criteria" and "reported device performance" are based on mechanical properties and material standards rather than diagnostic accuracy metrics. The document asserts that the device met these criteria through various tests, demonstrating substantial equivalence to predicate devices.

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

• Sample Size (Test Set): Not applicable in the context of diagnostic accuracy. For mechanical testing, "samples" would refer to the number of physical devices or components tested. This number is not specified in the 510(k) summary, but it would typically be a statistical minimum required by the testing standard.
• Data Provenance: Not applicable for clinical data. The performance data is derived from in vitro mechanical testing conducted by the manufacturer, Corentec Co., Ltd., in South Korea.

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

• Not applicable. This device is a physical implant, not a diagnostic AI/software. There is no "ground truth" derived from expert interpretation in the clinical diagnostic sense. The ground truth for mechanical properties is established by adherence to recognized engineering and material standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication for mechanical testing of this nature. Test results are compared against predefined acceptance criteria from international standards.

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 a physical orthopedic implant, not an AI/software.

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

• Not applicable. This is a physical orthopedic implant, not an AI/software.

7. The type of ground truth used:

• Ground Truth Type: For orthopedic implants, the "ground truth" is defined by adherence to established engineering and material standards (e.g., ISO and ASTM standards for mechanical properties, material composition, and sterilization validation). The device's performance is compared against the requirements and benchmarks set by these standards, and against the equivalent performance of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical orthopedic implant. There is no "training set" in the context of machine learning. Design and manufacturing processes would be informed by engineering principles and historical data on similar devices, but not a "training set" in the requested sense.

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

• Not applicable. As above, there is no training set. Design and manufacturing are based on established engineering principles and compliance with international standards.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.

Signature Orthopaedics' BiPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

The Remedy™ and Pegasus™ hip stems are intended for cementless use in total hip arthroplasty. The Evolve™ hip stem is intended for cemented total hip arthroplasty. The Remedy™, Pegasus™ and Evolve™ hip stems connect to a femoral head (cobalt-chrome alloy or ceramic) via 12/14 taper connection.

The Remedy™ Hip Stem has a tapered wedge geometry. The stem is manufactured from titanium alloy per ASTM F136. The proximal stem is porous coated with titanium beads and particles per ASTM F67 and the distal stem is matte finished.

The Pegasus™ is a double tapered, straight stem with rectangular cross-section. The stem has a lateral wing for engaging the greater trochanter. The stem is manufactured from titanium alloy per ASTM F136. The stem is grit blasted below the resection line.

The Evolve™ Hip Stem is a highly polished, tapered wedge stem with a rounded crosssection. The Evolve™ Hip Stem is manufactured from high nitrogen stainless steel per ISO 5832-9. The Evolve™ Hip Stem is available in two variants, the Masters series and the Helios Series. Both variants share similar general geometry but are sized differently to provide a more complete range. The Evolve™ Hip Stem includes two accessories, the Evolve™ Distal Centralizer and Evolve™ Cement Plug. The Evolve™ Distal Centralizer is a PMMA cap that sits on the end of the Evolve™ Hip Stem and centralizes it within the femoral canal. The Evolve™ Cement Plug is manufactured from polyethylene per ASTM F648 and is pressed into the femoral canal prior to inserting the Evolve™ Hip Stem to allow cement pressurization.

The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 28mm cobalt-chrome femoral head (K121297). The 28mm femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.

The provided text describes a 510(k) premarket notification for various hip implants (Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head) and details the non-clinical performance testing conducted to support their substantial equivalence claim to predicate devices. It does not present acceptance criteria in a quantitative format, nor does it detail a clinical study with a control group or human readers.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it lists general performance tests conducted and then concludes that "Non-clinical testing results support the substantial equivalence claim. The RemedyTM, Pegasus™ and Evolve™ Hip Stems and BiPolar Head are expected to perform adequately during clinical use."

The performance tests conducted include:

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

The document refers to "non-clinical testing and engineering evaluations." This implies in-vitro or bench testing, not patient data. Therefore, concepts like sample size, country of origin, or retrospective/prospective for a patient-based test set are not applicable here. The "test set" would consist of the orthopedic implants subjected to the various physical and mechanical tests. The sample sizes for each specific test are not reported. The company is Australia-based (Signature Orthopaedics Pty Ltd, Lane Cove, NSW 2066, Australia).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is a physical hip implant. "Ground truth" in this context would refer to the physical and mechanical properties of the device as measured by engineering standards, not expert interpretations of medical images or clinical outcomes.

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

This question is not applicable as the evaluation involves non-clinical engineering tests, not human interpretation or adjudication of medical data.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. The document describes hip implants, which are surgical devices, and the testing performed is non-clinical engineering evaluation.

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

No, a standalone algorithm performance study was not done. This question is also relevant for AI/software as a medical device (SaMD) and does not apply to physical hip implants.

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

For this type of device, the "ground truth" for the non-clinical testing refers to established engineering standards, material properties, and biomechanical principles. For example, fatigue testing would compare the device's performance against known limits for medical implants, and material characterization would be compared against ASTM or ISO standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in this context would imply the manufacturing and design process of the device itself and the various components.

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

This question is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of the implants would be established through engineering specifications, material selection criteria based on ISO/ASTM standards, and biomechanical research for hip implant design.

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The Exeter II Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

The Exeter Intramedullary Bone Plug is a molded acrylic device that is designed to be placed in the femoral canal prior to the insertion of a femoral stem. The bone plug restricts the migration of bone cement down the femoral canal and permits cement pressurization within the canal. The Bone Plug is a cone shaped device available in a range of diameters to accomodate various anatomical requirements. The distal portion of the plug is designed with circumferential ridges that create an interference fit between the plug and the femoral canal. Slots are cut into the ridge portion of the bone plug to allow the plug to compress slightly during insertion down the canal. The body of the plug contains a threaded portion for use with an insertion instrument.

The provided text describes a 510(k) submission for a medical device called the "Exeter Intramedullary Bone Plug." The submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of regulatory submission. The document explicitly states: "The substantial equivalence of the Exeter Bone Plug is based on an equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to the Howmedica's polyethylene Exeter Bone Plug, (K933077) and Exeter II Distal Centralizer (K974054)."

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

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

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence: Equivalence in intended use, design, materials, operational principles, and relative indications and contraindications to predicate devices.	The device is described as having the "same design as the currently marketed device" and is stated to be substantially equivalent to K933077 and K974054 based on the criteria listed. No specific performance metrics (e.g., bone cement restriction percentage or pressurization values) are provided.

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

   • Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance data from a test set.
   • Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. Ground truth assessment by experts for a test set is not described in this type of submission.

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

   • Not applicable.

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-assisted diagnostic device.

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 (expert consensus, pathology, outcomes data, etc.)

   • Not applicable. The "ground truth" in this context is the performance and safety established for the predicate devices, which is what the new device is compared to for substantial equivalence. No new ground truth data is generated for this specific submission as it relies on equivalence.

8. The sample size for the training set

   • Not applicable. This is not a machine learning device.

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

   • Not applicable.

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