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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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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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The REFLECTION 3 Acelabular System is 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 meumatoid adhritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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.

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

The REFLECTION 3 Acetabular System consists of acetabular shells and liners. The REFLECTION 3 Shells are manufactured from titanium alloy. The REFLECTION 3 liners are manufactured from XLPE. The design of the shells and liners are similar to the REFLECTION Acetabular Shell, the REFLECTION Interfit Shell, and the 10MRad REFLECTION Acetabular Liner.

Device Acceptance Criteria and Study Details:

This submission (K061253) describes the REFLECTION 3 Acetabular System, a hip joint prosthesis. The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than a de novo clinical study with specific acceptance criteria and performance metrics.

Therefore, the typical structure for reporting acceptance criteria and study results, as requested in the prompt, is not directly applicable to this type of regulatory submission in the same way it would be for a novel device undergoing extensive clinical trials for efficacy and safety.

The "acceptance criteria" here is not a set of performance metrics achieved in a study, but rather the FDA's determination of "substantial equivalence" to predicate devices. The "study" that "proves" the device meets this acceptance criteria is the 510(k) submission itself, which provides comparative information.

Based on the provided information, here's a breakdown in the requested format, acknowledging the nature of a 510(k) with its focus on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. A 510(k) typically relies on comparisons to existing, legally marketed predicate devices, supported by bench testing and Design Control Activities, rather than a "test set" from a prospective clinical study with performance endpoints.
• Data Provenance: Not applicable. The submission refers to "Design Control Activities" which would encompass various engineering tests, material characterization, and comparisons, but not specific patient data from a "test set" in the sense of a clinical trial. The "provenance" here is manufacturing data and engineering analysis.

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

• Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes for a test set, is not established for this type of submission. The "ground truth" for a 510(k) revolves around demonstrating equivalence to already approved devices. The FDA, with its regulatory experts, reviews the evidence provided by the manufacturer.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in this type of submission.

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

• No, an MRMC comparative effectiveness study was not done for this 510(k) submission. This type of study is more common for diagnostic devices where human reader performance is a key metric.

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

• Not applicable. This is a physical medical device (hip implant), not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (REFLECTION Acetabular System, REFLECTION Interfit Shell, and 10MRad REFLECTION Acetabular Liner). The submission implicitly uses the regulatory history and performance of these predicates as the benchmark ("ground truth") against which the new device is compared for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI 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 or revision surgery where other treatments 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; congenital dysplasia; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic dysplasia; 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.

Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior wall deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.

The Contour HA Coated Reconstruction Ring features a partial cup shape, multiple screw holes and three flanges. The reconstruction ring is secured to host bone or graft bone with bone screws. A Reflection All Poly Cup may be cemented in the reconstruction ring with polymethylmethacrylate (PMMA) bone cement.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document describes a 510(k) premarket notification for a medical device called the "Contour HA Coated Reconstruction Ring". It primarily focuses on:

• Intended Use: What the device is designed for (total hip components and acetabular reinforcement/reconstruction rings).
• Device Description: A brief physical description of the ring.
• Substantial Equivalence: The core of a 510(k) submission, where the manufacturer claims the new device is as safe and effective as existing legally marketed devices (predicates). This is evidenced by comparing materials, indications for use, and design.

The FDA's response confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. However, this type of submission usually relies on demonstrating equivalence through design and material comparisons, rather than extensive clinical performance studies with specific statistical acceptance criteria that would typically be described for a new, novel device or for performance claims.

Therefore, I cannot provide the requested information.

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The Indications for Use of the ViroSafe® ODR Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.

Not Found

This is a 510(k) premarket notification for the Buffalo Filter Virosafe ODR Filter, a smoke evacuation filter. The document indicates that the device has been found substantially equivalent to a predicate device marketed prior to May 28, 1976. This type of regulatory submission primarily focuses on demonstrating equivalence rather than conducting a de novo study to establish acceptance criteria and prove performance through a new clinical trial.

Therefore, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. These aspects are typically found in a de novo submission or a more extensive clinical study report, which are not part of this 510(k) clearance letter.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report specific device performance data. It focuses on regulatory clearance based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on expert review or ground truth establishment for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set evaluation details are provided.
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 filter, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth information is provided as it's not a diagnostic device requiring such validation in this context.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

The "Indications for Use" section (Page 3) briefly describes the intended function of the device: "for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices." However, it does not state specific performance metrics or acceptance criteria related to filtration efficiency, flow rate, or other technical specifications that would typically be associated with such a filter and evaluated in a performance study.

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