Search Results

Total Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.

Unicompartmental Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer® Patient Specific Instruments are intended for single use only.

The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'''' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

The provided text is a 510(k) Premarket Notification for the Zimmer Patient Specific Instruments System 6.0. It describes the device, its intended use, and its technological characteristics as compared to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or detailed performance studies.

Instead, the document states: "Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device." This indicates that the device's performance was evaluated against the predicate device, Zimmer Patient Specific Instruments System 4.0 (K113829) and 5.0 (K121640), rather than against pre-defined, quantitative acceptance criteria for new performance claims.

Therefore, I cannot provide the requested information for the following points:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to previously cleared devices through technological similarity and general software verification and validation, rather than presenting a standalone performance study with specific acceptance criteria.

Ask a specific question about this device

Total Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural – Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.

Unicompartmental Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer® Patient Specific Instruments are intended for single use only.

The subject 'device Zimmer® Patient Specific Instruments System 5.4 is a modification to the predicate device Zimmer® Patient Specific Instruments System 5.0 (K121640) to accommodate the new compatible implant system Zimmer® Personalized Knee System Trabecular Metal™ components cleared via 510(k) K122745 and K121771. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persono™ Trabecular Metal™ components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

Here's an analysis of the provided text regarding the Zimmer Patient Specific Instruments System 5.4, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative manner (e.g., target accuracy percentages, deviation limits). Instead, it relies on the concept of "substantial equivalence" to a predicate device.

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

The document mentions "Non-clinical tests using saw bones" for performance evaluation.

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: The tests were "Non-clinical" and used "saw bones." This implies an in vitro or laboratory setting, not patient data. No country of origin is mentioned for this testing. It is a retrospective analysis of the device's performance under controlled conditions, not utilizing patient data.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth specific to the saw bone testing. Since it's saw bone testing, the "ground truth" would likely be established by precise measurements or engineering specifications rather than expert medical interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of saw bone testing, where physical measurements confirm accuracy, expert adjudication in the typical clinical sense would not be applicable.

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

No, a multi-reader multi-case comparative effectiveness study was not mentioned. The evaluation primarily focuses on the device's standalone performance in a non-clinical setting and its substantial equivalence to a predicate, not on how it improves human reader performance.

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

Yes, a standalone performance evaluation was done. The "Non-clinical tests using saw bones" without mention of human interaction suggests a standalone evaluation of the device's accuracy and performance. The software device, Zimmer Patient Specific Instruments Planner (ZPSIP), generates a pre-surgical plan, and the hardware (ZPSI) transfers this plan. The testing verifies the system's ability to "perform as intended" in this capacity, i.e., accurate planning and guidance.

7. Type of Ground Truth Used

The ground truth for the saw bone testing would be based on physical measurements and engineering specifications against the planned surgical cuts/positions. For example, if the device is intended to guide a cut at a specific angle, the ground truth would be the actual measured angle of the cut made on the saw bone. It is not expert consensus, pathology, or outcomes data, as these are typically associated with human patient clinical data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set. This is a medical device clearance based on substantial equivalence, and typical AI/ML "training sets" are not explicitly mentioned as part of the evaluation. The software component, ZPSIP, implies some form of algorithmic processing, but the development and training details are not disclosed in this summary.

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

As no training set is described, there is no information on how its ground truth was established.

Ask a specific question about this device

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

The subject device Zimmer Patient Specific Instruments System 5.0 is a modification to the predicate device Zimmer Patient Specific Instruments System 2.5 (K111492) to accommodate the new compatible implant system Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses cleared via 510(k) K113369. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly detail specific quantitative acceptance criteria. Instead, it states that "the accuracy and performance of the system is adequate to perform as intended" based on non-clinical testing.

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

• Sample Size: Not explicitly stated in terms of a specific number of cases or patients. The testing was conducted using "cadaveric specimens and saw bones."
• Data Provenance: The testing was non-clinical. The "cadaveric specimens and saw bones" represent simulated rather than real patient data. There is no information on the country of origin, and it is inherently a prospective test on these simulated models.

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

Not applicable. The ground truth for the non-clinical tests on cadaveric specimens and saw bones would likely be established through precise measurements and physical verification, not expert consensus. There is no mention of experts being involved in establishing the ground truth for this testing.

4. Adjudication Method for the Test Set:

Not applicable. As the testing was non-clinical using cadaveric specimens and saw bones, and ground truth was likely established through physical measurements, there would be no need for an adjudication method among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document focuses on the device's standalone performance and its substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance evaluation of the algorithm (referred to as the "system") was done. The "Performance Data" section states: "Non-clinical tests using cadaveric specimens and saw bones have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Results of software verification testing demonstrated the device can be used safe and effective as intended." This indicates that the device's functional performance was evaluated independently.

7. Type of Ground Truth Used:

The ground truth used for the non-clinical tests would have been based on physical measurements and known anatomical features/target positions on the cadaveric specimens and saw bones. This is a form of objective, empirical ground truth rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies.

8. Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. The focus is on the testing of the final device, not on its development or training phase.

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

Not applicable, as no information on a training set is provided.

Ask a specific question about this device

The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing and Zimmer Gender Solutions Natural – Knee Flex fixed bearing prostheses families only. The Zimmer Patient Specific Instruments are intended for single use only.

The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer Gender Solutions Natural – Knee Flex fixed bearing prostheses families.

The provided text describes the Zimmer Patient Specific Instruments System, which includes a software component (Zimmer Patient Specific Instruments Planner) and a hardware component (Zimmer Patient Specific Instruments). The system is designed to assist surgeons in the placement of total knee replacement components.

However, the 510(k) summary does not contain detailed information about specific acceptance criteria or a comprehensive study report proving the device meets particular benchmarks. The performance data section is very brief, stating:

"Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended."

And for clinical data: "Not applicable."

Therefore, based solely on the provided text, a full table of acceptance criteria and a detailed study description cannot be generated. The document primarily focuses on regulatory submission details, device description, and substantial equivalence to a predicate device, rather than a detailed performance study.

Here's an attempt to answer the questions based on the limited information available in the provided document, acknowledging significant gaps:

Acceptance Criteria and Device Performance Study (Based on Limited Information)

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

Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics are not explicitly stated. The document only provides a high-level qualitative statement regarding performance.

2. Sample sized 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 any sample sizes for test sets or data provenance. The "non-clinical tests" are mentioned without further detail regarding the nature of data used.

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)

The document does not provide any information about experts used for establishing ground truth or their qualifications. The "non-clinical tests" are not described with this level of detail.

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

The document does not provide any information about adjudication methods.

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

The document does not describe an MRMC study, nor does it mention any comparison of human readers with or without AI assistance. The system is described as assisting the surgeon, but no comparative effectiveness data is presented. The device is a planning and guiding system, not an AI for interpretation that would involve "human readers."

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

The software component (Zimmer Patient Specific Instruments Planner) is used pre-operatively by a qualified surgeon to "inspect, fine-tune and approve the pre-surgical plan." This indicates a human-in-the-loop process. The document does not describe a standalone algorithm-only performance evaluation for the planning software. The hardware component (Zimmer Patient Specific Instruments) is a patient-specific template, which is by nature a standalone manufactured item based on the approved plan.

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

The document does not specify the type of ground truth used for its "non-clinical tests." For a device that assists in positioning, ground truth would typically relate to anatomical accuracy of the generated plan or the delivered template's guidance, but no details are provided.

8. The sample size for the training set

The document does not mention a training set sample size. Given the submission date (2009) and the description, it's unclear if "AI" in the modern sense of machine learning was heavily involved in a way that would necessitate a large training set as understood today. The software generates a pre-surgical plan based on MRI data, which could imply rule-based algorithms or image processing, rather than deep learning requiring extensive training data.

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

The document does not provide any information about a training set or how its ground truth might have been established.

Conclusion:

The provided 510(k) summary for K093533 is very high-level regarding performance data. It explicitly states "Clinical data: Not applicable" and provides only a generic statement about non-clinical tests verifying "adequacy" of accuracy and performance. It lacks the detailed information typically found in study reports for specific acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.

Ask a specific question about this device