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BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for cementless use in 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 Mirabo Z Cup Cortinium is a porous coated non hemispherical outer shell made of Ti-6Al-4V alloy (ASTM F136) via machining processes and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process. The device design allows for the cementless use of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation.

The provided text is a 510(k) premarket notification for the BENCOX Mirabo Z Cup Cortinium. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices. However, it does not contain information about acceptance criteria, detailed study results proving a device meets acceptance criteria, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

This document focuses on regulatory compliance through substantial equivalence, primarily based on design and material similarities, and a set of non-clinical bench tests comparing the device to existing standards and predicate devices.

Therefore, I cannot fulfill your request for this specific information based on the provided text. The document states "Device Comparisons and performance testing indicate that the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles," and lists the nonclinical testing performed (e.g., Cup Fatigue Testing per ASTM F3090-20, Porous Structure Characterization per various ASTM and DIN EN ISO standards). These tests are typically performed to demonstrate that the device meets existing standards and is comparable to previously cleared devices, rather than establishing specific acceptance criteria and proving performance against them in a clinical study format.

In summary, the provided document does not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a clinical performance study.

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The REDAPT Modular Acetabular Shells are indicated for:

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The REDAPT Modular Acetabular Shell is for single use only and is intended for cementless use.

The subject of this Traditional 510(k) is the REDAPT Modular Acetabular Shells. The REDAPT Modular Acetabular Shells are a line extension to the REDAPT Porous Acetabular Shells to allow the un-cemented use of R3 Poly liners. The REDAPT Porous Acetabular Shells were previously cleared for market via premarket notification K150790.

The REDAPT Modular Acetabular Shells are available in same size range as REDAPT Porous Acetabular Shells from 48 mm to 80 mm. The REDAPT Modular Acetabular Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and has identical porous structure as the predicate REDAPT Porous Acetabular Shell. The inner surface of the subject REDAPT Modular Acetabular shell is modified by a machining process to have an identical inner geometry and locking mechanism as the R3 Multi-hole shells to allow the uncemented use of R3 poly liners that are cleared to use with R3 Multi-hole Shell. The R3 Multi-hole Shells are most recently cleared under premarket notification K092386.The R3 XLPE liners were cleared under 510(k) K070756 and K113848 and the R3 Constrained Liners were cleared under K111635, K122139 and K162641.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the REDAPT Modular Acetabular Shell.

It's important to note that this document is a Traditional 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within the context of showing equivalence to existing, cleared devices.

Summary of Acceptance Criteria and Device Performance

Study Details:

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

   • The document describes non-clinical bench (mechanical) testing and Finite Element Analysis (FEA). It does not specify sample sizes (e.g., number of shells tested) for each individual mechanical test. For FEA, it's a computational model, so a "sample size" in the traditional sense doesn't apply.
   • Data provenance: Bench testing results are typically generated in a controlled laboratory environment. The document does not specify the country of origin of the data
   • Retrospective or Prospective: These are laboratory-based mechanical tests, not clinical studies, so the terms "retrospective" or "prospective" are not applicable.

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

   • This submission relies on bench testing and comparison to predicate devices. It does not involve establishing a "ground truth" based on expert consensus for clinical interpretation or diagnosis. The "ground truth" for these tests are objective measurements against established engineering standards or comparisons to the performance of predicate devices.
   • The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for conducting and interpreting the mechanical tests. Their specific numbers and qualifications are not detailed in this summary, but would be expected to be highly experienced in medical device testing.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1 or 3+1 consensus). The "adjudication" is based on whether the devices meet pre-defined engineering specifications or perform comparably to predicate devices in controlled bench tests.

4. 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, an MRMC comparative effectiveness study was not done. This is a mechanical device, not an AI or imaging diagnostic tool. Therefore, human reader performance or AI assistance effects are irrelevant here.

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

   • Not applicable as this is a mechanical medical device, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" can be considered as:
     • Objective engineering standards and specifications: For mechanical tests like fatigue, dissociation, and biocompatibility, there are defined standards and acceptable limits.
     • Predicate device performance: The ultimate "ground truth" for this 510(k) is the demonstrated safe and effective performance of its predicate devices, K150790, K092386, and K920430, which the new device aims to be substantially equivalent to.
     • Laboratory measurements: Empirical data derived from the bench testing.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.

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

   • Not applicable (see point 7).

In conclusion, the study supporting the REDAPT Modular Acetabular Shell primarily consists of non-clinical bench (mechanical) testing and analysis (including Finite Element Analysis) to demonstrate substantial equivalence to existing, legally marketed predicate devices. The "acceptance criteria" are met if the device performs comparably to or within the established safety and performance envelopes of the predicate devices and relevant engineering standards.

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· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.

REDAPT™ Augments are intended for single use only and are to be implanted with bone cement to the mating acetabular shell and without bone cement to the bone interface

Augments are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously.

Subject of this Traditional premarket notification are the REDAPT® Augments. The subject devices are acetabular augment hip components to be used to fill bone voids where significant bone loss is present and a cup alone cannot fill the void.

This document is a 510(k) Premarket Notification from the FDA regarding the "Smith & Nephew, Inc. REDAPT Augments." It describes the device, its intended use, and the pre-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.

Summary of Acceptance Criteria and Study:

The document focuses on substantiating the equivalence of the REDAPT Augments to predicate devices, primarily through engineering analysis and mechanical testing, rather than an AI/ML-based study with specific acceptance criteria for algorithm performance. Therefore, many of the requested points related to AI/ML performance, ground truth, expert review, MRMC studies, and training data are not applicable to this 510(k) submission.

The "acceptance criteria" in this context are implicitly the successful completion of the described pre-clinical tests and the demonstration that the results are equivalent to or better than the predicate devices, thereby ensuring safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, with "N/A" for sections not covered by this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document refers to "worst-case products" and "representative samples" for testing. Specific numerical sample sizes for each mechanical or chemical test are not provided in this summary.
• Data Provenance: N/A for this type of testing (not clinical data or image data). The tests were conducted on manufactured device samples.

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

• N/A. This is pre-clinical engineering and laboratory testing, not a study requiring human expert interpretation of data for ground truth establishment in the context of AI/ML.

4. Adjudication Method for the Test Set:

• N/A.

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:

• N/A. This is not an AI/ML device, nor is it a clinical study comparing human reader performance.

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

• N/A. This is a medical implant device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these tests is based on established engineering principles, material science standards, and in vitro testing methodologies. For example, "successful completion" of fatigue testing means the device withstood the specified cyclical loads without failure or excessive deformation, as defined by the test protocol and industry standards. Comparison to predicate device performance also serves as a benchmark.

8. The Sample Size for the Training Set:

• N/A. This product does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set was Established:

• N/A.

Additional Context from the Document:

• Clinical Data: The summary explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
• Substantial Equivalence: The overarching goal of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices based on intended use, indications, and performance characteristics, primarily through the pre-clinical engineering and laboratory testing described.
• Technological Characteristics: The augment devices use the same titanium alloy, sterilization method, porous structure, and manufacturing as previous cleared devices. Key differences identified are geometry, size offering, and additive manufacturing method (Ti-6Al-4V).

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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.

K113848 is a 510(k) premarket notification for a modification to an existing device, the R3 XLPE Acetabular Liners, not a study involving AI or human readers. The provided text describes mechanical testing performed to demonstrate that the modified device is substantially equivalent to predicate devices, and thus does not include the typical elements of an AI-based regulatory submission.

Therefore, many of the requested categories are not applicable to this submission.

Here is the information that can be extracted or deduced from the provided document:

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

The document mentions that the submission was prepared in accordance with the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. This guidance document would contain the specific acceptance criteria for each test. The actual numerical acceptance criteria for each test are not explicitly stated in the provided text, nor are the specific numerical results.

The following types of mechanical tests were performed:

• Push-out Testing
• Torque-to-Failure Testing
• Lever-out Testing
• Fatigue Testing
• Post-Fatigue Push-out Testing

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The document does not specify the country of origin for the test data. Given the "Submitted by Smith & Nephew, Inc. Advanced Surgical Devices Division, Cordova, Tennessee," it is highly likely the testing was conducted in the USA or by a facility contracted by a US entity for a US submission. The testing is a prospective assessment of the device's mechanical properties, not human-derived data.

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. This submission is for a medical device (acetabular liners) and involves mechanical testing, not a diagnostic algorithm that requires expert-established ground truth from images or clinical data. The "ground truth" here is the physical performance of the device against engineering standards.

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

• Not applicable. As this is mechanical testing of a physical device, there is no expert adjudication process in the sense of clinical interpretations or diagnoses. The "adjudication" is compliance with engineering standards and guidance.

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. No MRMC study was conducted. This device is a physical implant, not an AI-assisted diagnostic tool. No human readers or AI were involved in the testing for this submission.

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

• Not applicable. This is a physical medical device. There is no algorithm to evaluate.

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

• The "ground truth" for this submission is established through physical mechanical testing according to recognized engineering standards and FDA guidance documents (specifically, the "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995). The acceptance criteria outlined in such guidance documents serve as the standard for performance.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical testing for a physical medical device. This term applies to machine learning models.

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

• Not applicable. As above, there is no training set for a physical device's mechanical testing.

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Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.

The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:

The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.

Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:

• Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
• Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
• Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.

The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.

Given this context, here's the information extracted from the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.

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

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
• Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.

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

• Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
• Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.

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

• No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
  • For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.

In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.

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