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The REDAPT Porous Acetabular Shell and Cemented Liner 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 Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.

The REDAPT Porous Acetabular Shell designed for cementless use is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.

This document is a 510(k) summary for the REDAPT Porous Acetabular Shell and Cemented Liner, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a traditional study with acceptance criteria and a detailed analysis of performance metrics in clinical trials.

Therefore, the requested information categories (#1-7 for a study and its acceptance criteria, and specific details for #8-9 for training sets) are generally not applicable in the context of this medical device submission. The FDA 510(k) process for devices like this typically relies on bench testing, material characterization, and comparisons to predicate devices to establish substantial equivalence, rather than extensive human clinical trials or AI performance evaluations.

However, I can extract the information provided that is relevant to the nature of this submission:

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

The document does not provide a table of acceptance criteria for a study with reported device performance in the way one might expect for a clinical trial or AI performance evaluation. Instead, it lists various tests performed to establish substantial equivalence. The "performance" is implied by the successful completion of these tests and the determination of substantial equivalence to predicate devices, meaning the device performed comparably or met established standards for the indicated tests.

The listed tests are:

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

• Sample Size: Not specified for each test. For mechanical and material tests of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., 5-10 samples per test group). The document does not provide these details.
• Data Provenance: Not specified. Standard practice for such tests would be laboratory testing conducted by the manufacturer or a contracted testing facility in a controlled environment.

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 is a submission for a physical medical device (hip implant components), not for an interpretative AI/imaging device. "Ground truth" in this context would refer to the validated material properties, mechanical performance under specified loads, and biocompatibility, which are established through standardized laboratory testing protocols, not expert consensus on interpretations.

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

Not applicable, as this is not a study requiring adjudication of expert opinions.

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. The device is a physical hip implant.

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

Not applicable. The device is a physical hip implant.

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

The "ground truth" for this device's evaluation relies on:

• Physical and Chemical Material Standards: Adherence to established ASTM (e.g., ASTM F648 for cross-linked polyethylene) and ISO standards for materials like titanium alloy and polyethylene.
• Mechanical Test Standards: Compliance with relevant mechanical testing standards (e.g., for fatigue, screw fixation, wear simulation) that simulate in vivo conditions.
• Biocompatibility Standards: Compliance with ISO 10993 series or similar standards for biological evaluation of medical devices.
• Comparison to Predicate Devices: Performance characteristics (e.g., wear, mechanical strength) found to be substantially equivalent to those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" in the context of this device's submission.

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

Not applicable.

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Smith & Nephew Hip Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Hip System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use. Smith & Nephew Hip System Instruments can be organized into instrument families which are categorized as follows: Trials, Reamers, Handles, Impactors, Broaches, Guides, Cutter, Inserter/Extractor, Tightening, and Drills.

The provided document is a 510(k) Premarket Notification for Hip System Instruments from Smith & Nephew, Inc. This document focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a clinical study with specific acceptance criteria and performance metrics for a new device's efficacy or safety.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The core of this submission is to demonstrate that the Hip System Instruments (which are surgical tools, not implants) are similar enough in their materials, manufacturing processes, sterilization, and body contact to already cleared predicate instruments, thus not requiring a new detailed clinical performance study.

Here's what can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. This document does not describe a clinical performance study with a test set of data. The "test" for these instruments is demonstrating similarity to predicate devices via design rationale and manufacturing details.
• Data Provenance: Not applicable. There is no mention of clinical data (retrospective or prospective) or country of origin for such data.

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

• Number of Experts: Not applicable. Ground truth establishment for a clinical study is not described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

• MRMC Study: No. This document is for surgical instruments, not an AI-assisted device.
• Effect Size: Not applicable.

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

• Standalone Performance: No. This document is for surgical instruments, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No clinical ground truth is established or discussed for these surgical instruments.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This document does not describe a machine learning algorithm or a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

Explanation for Lack of Data:

This 510(k) submission for "Hip System Instruments" is for accessory devices (surgical tools) used to implant Smith & Nephew Hip Systems. The primary regulatory pathway for such devices, when they are similar to already marketed devices, is to demonstrate substantial equivalence.

The key arguments for substantial equivalence are provided in the section titled "Substantial Equivalence Information":

• Shared Raw Materials: The instruments use the same raw materials as predicate devices.
• Same Manufacturing Processes: The instruments are manufactured using the same processes as predicate devices.
• Same Sterilization Procedures: The instruments utilize the same sterilization procedures as predicate devices.
• Similar Nature of Body Contact: The instruments have similar body contact characteristics to predicate devices.
• Similar Design and Function: The instruments are similar in design and function to competing total hip surgical instrumentation already on the market.

Conclusion:

This document is a regulatory submission for surgical instruments based on substantial equivalence, not a clinical study involving performance metrics, acceptance criteria, or AI components. Therefore, the detailed information requested about acceptance criteria and study particulars for a clinical evaluation is not present in this text.

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The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings 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. The device is for single use.

The Reflection Acetabular Reinforcement Ring is a device intended to address acetabular defects. The rings are manufactured from titanium in a variety of sizes to accommodate the needs of patients.

This document is a 510(k) summary for a medical device (Reflection Acetabular Reinforcement Rings) submitted in 1996. The information provided is for regulatory clearance based on substantial equivalence to predicate devices already on the market.

It is important to note that this type of submission (510(k)) generally does not involve clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparisons of AI-assisted vs. non-AI-assisted human performance in the way a modern AI/ML device would.

Therefore, I cannot provide the requested information in the format of a typical AI/ML device study. The document focuses on demonstrating similarity to existing devices rather than proving performance against specific acceptance criteria through novel studies.

Here's an explanation based on the provided text, highlighting why the requested information cannot be fully provided:

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

• Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions of this era for mechanical implants, acceptance criteria would typically revolve around material specifications, dimensional tolerances, and mechanical testing (e.g., fatigue, static strength) to ensure the device performs similarly to predicate devices. These are not detailed in this summary.
• Reported Device Performance: The document states, "The safety and effectiveness of the Reflection Acetabular Reinforcement Rings System is based on the long history of use of these devices in the market place." This implies that the performance is considered equivalent to the predicate devices due to their established clinical use. No specific, quantifiable performance metrics for the Reflection rings themselves are reported from a dedicated study.

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

• Not applicable. No clinical "test set" in the context of an AI/ML study is mentioned. The safety and effectiveness are established by reference to the pre-existing market history of similar devices, not through a prospective or retrospective study of the Reflection Acetabular Reinforcement Rings specifically.

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. There is no "test set" requiring expert-established ground truth mentioned in this 510(k) summary.

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

• Not applicable. No test set or expert adjudication is described.

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 mechanical implant (acetabular ring), not an AI/ML diagnostic aid. Therefore, no MRMC study, human reader performance, or AI assistance is relevant.

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

• Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

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

• Not applicable. The "ground truth" for this 510(k) clearance is the established safe and effective clinical use of the predicate devices in the market, not a derived ground truth from a specific study for this new device.

8. The sample size for the training set

• Not applicable. This device is a mechanical implant; it does not involve AI/ML requiring a training set.

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

• Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission from 1996 for a mechanical implant. It follows the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria as would be expected for a modern AI/ML medical device.

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