Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Total hip components are 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 Modular Hip components are for single use only.

The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.

This document is a 510(k) premarket notification for a hip implant, which primarily focuses on establishing substantial equivalence to previously approved devices based on design, materials, and mechanical testing. It does not contain the kind of detailed clinical study data, acceptance criteria, or performance metrics typically seen in AI/software device submissions. Therefore, I cannot provide information for many of the requested fields.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for this submission type. The submission relies on mechanical test data and substantial equivalence to predicate devices, rather than clinical performance metrics with pre-defined acceptance criteria for accuracy, sensitivity, or specificity.

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

No test set of clinical data is described or used in this submission. The "test" mentioned refers to mechanical testing.

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

Not applicable. No clinical ground truth was established for a test set.

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/software device submission.

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 submission.

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

Not applicable for clinical performance. For mechanical performance, the "ground truth" would be the engineering specifications and established test methods for hip implants.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable.

Summary of Relevant Information from the Document:

• Acceptance Criteria (Implicit for mechanical testing): The device is "capable of withstanding expected in vivo loading without failure" and is "equivalent to devices currently used clinically." This is a general statement about mechanical integrity, not specific quantitative performance metrics.
• Study Proving Acceptance: "A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
• Sample Size for Mechanical Testing: Not explicitly stated, but mechanical testing of medical devices typically involves a specific number of samples tested to failure or for a specified number of cycles according to relevant ASTM or ISO standards. The document does not provide these details.
• Data Provenance (Mechanical Testing): The mechanical testing would have been conducted by the manufacturer, Smith & Nephew, Inc.
• Ground Truth (Mechanical Testing): Established through engineering specifications and industry-standard mechanical test protocols (e.g., ASTM F1472, ASTM F136 mentioned for materials).
• Substantial Equivalence: The primary "study" for this submission is a comparison to predicate devices, demonstrating similarity in "indications for use, design features, operational principles, and material composition."

In conclusion, this document describes a traditional medical device submission (hip implant) that relies on mechanical testing and substantial equivalence to predicate devices, not clinical studies with acceptance criteria relevant to AI or software performance.

Ask a specific question about this device