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The Journey Unicondylar Tibial Baseplates are indicated for restoring either compartment of a knee that has been affected by the following:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.
  The implants are labeled for single use only. The tibial baseplates are designed to be implanted using bone cement.

New unicondylar metal tibial baseplates have been designed and developed by Smith & Nephew Orthopaedics. In keeping with the design philosophy of the predicate Genesis Unicondylar Tibial Baseplates (K912735), the subject devices share the same design features such as:

• Shape (footprint)
• Size Offering (6 sizes with each size being offered in a RM/LL or LM/RL configuration)
• Cement Grooves
• Keel on Distal Surface
  Given that the newly designed Journey tibial baseplates contain the same shape (footprint) and locking mechanism as the existing Journey Unicondylar Tibial Baseplates, the subject devices are intended to inter-lock with the currently marketed Journey Unicondylar UHMWPe Articular Inserts (K061011) in order to form a unicondylar tibial construct to replace either the medial or lateral tibial compartment of the knee.

Here's a breakdown of the acceptance criteria and study information for the Smith & Nephew Journey Unicondylar Tibial Baseplates, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes mechanical testing, not a clinical study on human subjects. Therefore, the concept of a "test set" in the context of human data or a "sample size" for patients is not applicable here. The testing was conducted on prototype devices.

• Test Set (for mechanical testing): Not explicitly stated, but it would involve multiple samples of the tibial baseplates for each type of fatigue testing.
• Data Provenance: The testing was performed internally by Smith & Nephew Orthopaedics.

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

This question is not applicable to the provided document. The "ground truth" for mechanical testing is based on established engineering standards and physical phenomena, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving disagreements among multiple human reviewers in clinical studies, which is not relevant to mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device."

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

This question is not applicable. This device is a physical knee prosthesis, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and physical testing outcomes (e.g., ability to withstand specified loads and cycles without failure, cement adhesion strength). It is not based on expert consensus, pathology, or outcomes data in the medical sense, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable, as this is neither an AI/algorithm-based device nor a clinical study that would involve a training set of patient data.

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

This question is not applicable for the reasons outlined in point 8.

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The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and
• Treatment of fractures that are unmanageable using other techniques.
  The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.

New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735.

This 510(k) summary (K100197) describes the Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or AI device.

Therefore, the requested information elements related to a study proving acceptance criteria (like sample size, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable and cannot be extracted from this document because such a study is not part of this type of submission for this device.

The document states: "The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735." and "The Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts are similar to the following commercially available devices regarding design features, overall indications, and materials: Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735) and Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)."

This indicates that the device's acceptance is based on its substantial equivalence to predicate devices already on the market, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices without raising new questions of safety and effectiveness.

Therefore, here is an attempt to address the request based on the provided document and the nature of a 510(k) submission for a physical medical device like this:

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)

• Not applicable. This document describes a 510(k) submission for a physical orthopedic implant based on substantial equivalence, not a clinical study or a study involving a "test set" as understood for diagnostic or AI devices. The "data" provenance would relate to the design documents, material specifications, and regulatory history of the predicate devices.

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. "Ground truth" for a physical implant like this is established through engineering design, material science, and the regulatory history of similar devices. It does not involve expert consensus on interpreting data from a "test set" in the context of an AI or diagnostic study.

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

• Not applicable. No test set or adjudication process of this nature is described or relevant for this type of 510(k) submission.

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 an orthopedic implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported here.

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

• Not applicable. There is no algorithm or software component described in this 510(k) submission for standalone performance evaluation.

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

• Inferred: The "ground truth" for demonstrating the safety and effectiveness of this device is primarily based on the established safety and effectiveness of the predicate devices (K912735 and K061011) through previous regulatory clearances, and adherence to relevant material standards (for UHMWPe) and design principles for knee prostheses. This involves engineering data, material specifications, and historical clinical performance of similar devices, rather than a "ground truth" derived from patient-specific data in a clinical trial for a new diagnostic.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that utilizes training sets.

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

• Not applicable. As above, no training set is described or utilized for this medical device.

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The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

• 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Correction of functional deformity; 2.
• ల్లా Revision procedures where other treatments or devices have failed; and
• 4. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.

The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smith & Nephew Journey Unicondylar Femoral Implant.

Based on the provided 510(k) summary, this document is a premarket notification for a medical device (a unicondylar femoral implant), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study to prove the device meets specific performance acceptance criteria in the way a clinical trial or a diagnostic algorithm study would.

Therefore, I cannot populate most of the requested fields as they pertain to a type of study that isn't presented in this 510(k) document. Medical device 510(k) submissions, especially for orthopedic implants, often rely on design control activities and comparisons to predicate devices rather than human-in-the-loop diagnostic studies.

Here's what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) in the context of a diagnostic or comparative effectiveness study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device.

• Noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis)
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques.
  These indications align with common uses for unicondylar knee prostheses. |
  | Material Composition | Same as/similar to predicate device(s) | Offered in Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM). (These are common materials for implants). |
  | Design Features | Same as/similar to predicate device(s) | The femoral implants feature the same articular surface geometry as existing femoral implants cleared in K073175 (a predicate device). |
  | Safety and Effectiveness | Demonstrated through design control activities and equivalence to predicate. | "Design Control Activities have been completed and the results indicated that the subject device is safe and effective." (No specific performance data is provided). |

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or comparative effectiveness with a "test set" of data in the manner implied by the question. The "test" for this submission is the comparison to predicates and internal design control verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method 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 device is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For a 510(k) submission for an implant, the "ground truth" essentially comes from:
* Clinical history and established performance of predicate devices: The implicit understanding that similar devices with similar materials and designs have a history of safe and effective use.
* Engineering and materials science principles: The "ground truth" for the device's physical properties (strength, wear resistance, biocompatibility) are established through standard engineering tests and material specifications. The submission only states "Design Control Activities have been completed."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning study requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" presented in the 510(k):

The "study" in this context is a substantial equivalence demonstration as part of the 510(k) premarket notification process for a Class II medical device.

• Objective: To demonstrate that the Smith & Nephew Journey Unicondylar Femoral Implant is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
• Methodology:
  • Comparison of Intended Use: The device's indications for use are presented and implicitly compared to those of predicate devices.
  • Comparison of Technological Characteristics: The device's design features (articular surface geometry), materials (Cobalt Chrome, OXINIUM), and intended combination with other components are compared to cleared predicate devices, specifically K073175 (earlier Journey Unicondylar Femoral Implants), K912735 (GENESIS Unicompartmental Knee System), K030301 (Unicondylar Femoral Component), and K033363 (Zimmer Unicompartmental Knee System).
  • Reliance on Design Controls: The submission states that "Design Control Activities have been completed and the results indicated that the subject device is safe and effective." This refers to internal company processes for designing, developing, and verifying the device meets its specifications, often including mechanical testing, biocompatibility testing (if new materials are used, though here they are common), and software verification (if applicable).
• Data Provenance: The "data" primarily comes from in-house design and testing records ("Design Control Activities") and regulatory records of previously cleared devices (510(k) numbers K073175, K912735, K030301, K033363). The country of origin for the data is implicitly the USA (Smith & Nephew's location), and it is retrospective in the sense of referencing previously cleared devices and established design control processes.
• Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to the identified predicate devices, allowing it to be marketed.

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