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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

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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 (NDJD) 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 of the hip; and correction of deformity.

The ANTHOLOGY AFIT Hip Stem is for single use only. The ANTHOLOGY AFIT Hip Stem is intended for cementless use.

Subject of this Special premarket notification is the addition of a new stem design to the Smith & Nephew ANTHOLOGY™ Hip System. The ANTHOLOGY Hip System currently consists of the ANTHOLOGY Hip Stems cleared via premarket notification K052792. The proposed devices are ANTHOLOGY™ AFIT Hip Stems, new hip stems that will be marketed as part of the ANTHOLOGY Hip System.

The ANTHOLOGY AFIT Hip Stem represents minor design modifications when compared to the predicate ANTHOLOGY Hip Stem cleared via K052792. The ANTHOLOGY AFIT Hip Stem is manufactured from Titanium alloy (Ti-6Al-4V) per ASTM F1472. The proximal body is both porous-coated per ASTM F67 and hydroxyapatite-coated, the middle section is grit-blasted, and the distal end is glassbeaded. The ANTHOLOGY AFIT Hip Stem will be available in a size range of 3 to 14, in both a high and standard neck offset with a 12/14 taper.

This looks like a 510(k) premarket notification for a hip stem, which is a medical device. Based on the provided text, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have a test set, ground truth established by experts, or performance metrics like accuracy, sensitivity, or specificity.

The document discusses substantial equivalence for a physical hip implant (ANTHOLOGY™ AFIT Hip Stem) based on its similarity to a previously cleared predicate device (ANTHOLOGY Hip Stem cleared via K052792) and mechanical testing.

Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and performance of an AI/ML device, as this type of study was not performed or described in this document. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." and "A review of the existing ANTHOLOGY Hip Stem testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

Summary of what can be inferred from the document regarding the device's acceptance (though not an AI study):

The acceptance criteria for this device appear to be based on demonstrating substantial equivalence to a predicate device already on the market (Smith & Nephew, Inc. ANTHOLOGY Hip Stem, K052792). This includes demonstrating similarity in:

• Function
• Intended Use
• Indications for Use
• Material Composition
• Overall Design (with minor modifications demonstrated not to raise new safety/effectiveness issues)

The device performance is assessed through "existing mechanical testing performed" and a "Limulus Amebocyte Lysate (LAL) test" to determine pyrogen limit.

Therefore, the table and other points cannot be filled as requested because the document does not describe the kind of study you're asking about.

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The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are indicated for:

· Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.

· Fracture or avascular necrosis of the femoral head

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

• All forms of osteoarthritis

· Patients with hips at risk of distocation

· Femoral neck fracture or proximal fracture to hip joint

The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.

The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLUS Standard and Lateral Femoral Stems with TilHA cleared via K120211 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6AI-4V with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.

The provided document is a 510(k) premarket notification for a medical device, specifically the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA, which are components of a total hip joint replacement system.

Based on the nature of this document, it describes a
medical device, not an AI/ML algorithm or a diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details does not apply to this type of submission.

The document discusses mechanical testing to demonstrate the device's capability to withstand in vivo loading without failure, and it leverages equivalence to previously cleared predicate devices.

Here's the relevant information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format for mechanical performance or directly report numerical performance data for the POLARSTEM stems beyond general statements. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing.

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

This information is not applicable in the context of an AI/ML algorithm. For mechanical testing of medical devices, "sample size" refers to the number of physical devices tested. The document does not specify the exact number of stems subjected to fatigue testing, but standard practice involves testing multiple samples to statistical significance. The data provenance would be from laboratory mechanical testing, not human patient data in the typical sense of AI/ML.

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

This is not applicable. For this type of device, ground truth is established through engineering and material science principles, laboratory testing under controlled conditions, and compliance with recognized standards (e.g., ISO standards for orthopedic implants). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual 'cases' in the way it would apply to an AI diagnostic.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication is a process typically used for human review of data, often in clinical trials or for establishing ground truth labels in AI. Mechanical tests have objective pass/fail criteria.

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

This is not applicable. MRMC studies are used to evaluate the performance of diagnostic tools (often AI) with and without human assistance. This document describes a physical implantable device.

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

This is not applicable as it concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

• Mechanical Engineering Standards: Compliance with industry-recognized standards for orthopedic implants regarding fatigue, strength, and material properties.
• Material Science Principles: Verification of the properties of the Ti-6Al-4V alloy and the Ti/HA coating.
• Predicate Device Performance: The primary method for proving substantial equivalence involves demonstrating that the new device performs comparably to legally marketed predicate devices, which have a track record of safe and effective use.

8. The Sample Size for the Training Set:

This is not applicable. The device is not an AI/ML algorithm, so there is no "training set."

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

This is not applicable for the same reason as point 8.

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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; 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 Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

This 510/k) submission seeks FDA clearance to have the calcium phosphate coating (plasma sprayed from hydroxyapatite (HA) powder) on the subject hip components applied by an alternate coating supplier. The calcium phosphate coating is referred to as "HA coating." The hip system components included in this premarket notification are:

• . Porous Synergy Hip Stems
• . Non-Porous Synergy Stems
• Porous Anthology Hip Stems .
• . Porous Reflection Acetabular Shells

The Smith & Nephew Hip Stems with HA coating have been cleared for market by FDA via K052792, K002996 and K970337. The Reflection Acetabular cups with HA coating have been cleared for market by FDA via K990666 and K022556. The design, principle of operation, type of substrate materials, dimensional characteristics and indications for use will not change as a result of the implementation of an alternate HA coating supplier.

The provided document is a 510(k) summary for a medical device seeking FDA clearance. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than establishing de novo safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested elements regarding acceptance criteria, study design, statistical details, and ground truth establishment are not applicable or available in this type of regulatory submission. The document primarily describes how the new HA coating supplier's product matches the characteristics and performance of the predicate device's coating.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to the successful demonstration of substantial equivalence to predicate devices. This is achieved by showing that the new HA coating produced by the alternate supplier is chemically and physically comparable to the original, and that the HA-coated components maintain the equivalent performance characteristics.

Study Details (Applicable to 510(k) Substantial Equivalence, Not Clinical Studies)

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

   • Test Set: Not a traditional "test set" in the sense of clinical samples. The "test set" here refers to the actual device components and HA coating samples produced by the alternate supplier, which were subjected to various material and coating characterization tests. The specific number of samples for each test (e.g., how many HA powder lots, how many coated implants) is not specified in this summary.
   • Data Provenance: The tests were conducted on components manufactured by Smith & Nephew using the alternate HA coating supplier. The testing described appears to be laboratory-based (e.g., material characterization, physical property testing), not clinical data from patients. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject HA coated devices."

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

   • Not applicable. This submission relies on objective material and physical property testing, not expert interpretation of results to establish "ground truth" in a diagnostic sense. The "ground truth" (or benchmark) for comparison was the characteristics of the predicate device's HA coating and accepted industry standards/guidance documents.

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

   • Not applicable. Adjudication methods are used for interpreting subjective data (e.g., image reads, clinical endpoints). The data here are quantitative material and coating characteristics, which are objectively measured and compared to predefined specifications or predicate device characteristics.

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:

   • Not applicable. This is a hardware/material modification submission, not an AI/software device. No human reader studies were conducted or are relevant to this type of device.

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

   • Not applicable. This is a hardware/material modification submission, not an algorithm.

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

   • The "ground truth" for demonstrating substantial equivalence was a combination of:
     • Specifications and characteristics of the legally marketed predicate devices.
     • Relevant guidance documents (e.g., "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants," "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement").
     • Industry standards and established test methods (e.g., comparing to NIST SRM 2910|a) for certain parameters).
     • Regulatory definitions (e.g., 21 CFR 888.3358 for porosity).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for the device would be the manufacturing process development and quality control of the alternate coating supplier.

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

   • Not applicable. As above, no training set in the AI sense was used. The manufacturing process for the HA coating would have established its own internal quality control standards and specifications based on the desired material properties comparable to the predicate device.

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The SLR-PLUS Hip Stem is indicated for uncemented use in 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 Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.

Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.

The provided document is a 510(k) summary for a medical device (femoral stems), and it does not describe an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluations, such as ground truth, sample sizes for training/test sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing.

Here's an attempt to answer the questions based solely on the provided text, recognizing the limitations for an AI/ML context:

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

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 does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but it would typically be from laboratory testing rather than clinical data for this type of device.

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 is not applicable for a mechanical device. The "ground truth" for mechanical testing is established by compliance with the specified international standards (ASTM and ISO). No human experts are used to interpret the "ground truth" in this context.

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

Not applicable. Mechanical tests have objective outputs that are compared directly to standard specifications, not adjudicated by human experts.

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 device is a physical hip stem, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical hip stem, not an algorithm.

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

The "ground truth" for the performance of this device is adherence to mechanical performance standards (ASTM F 2068-03, ISO 7206-6, ISO 7206-4/8, EN ISO 21535). The performance is assessed against the requirements and specifications defined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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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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