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Pin Placement Guides: Signature Personalized Patient Care 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 Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & . Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. Cut-Through Guides: Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard M1™ Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty™ Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, AGC™ Complete Knee system and Vanguard™ XP Knee system. The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31. The Signature guides are intended for single use only.

The Signature Personalized Patient Care System consists of a software component, Signature Planner and a hardware component, Signature guides and is designed to assist the surgeon in the placement of Biomet total knee replacement components. The Signature guides are patient specific devices that are based on a pre-operative plan which is generated using the Signature Planner software. The Signature guides are produced based on the pre-operative plan and are manufactured to fit a specific patient. The Signature Planner software functions essentially the same as in K102795 and K110415, but is adapted to allow the use of Biomet Vanguard™ XP Knee system (K122160) for total knee arthroplasty procedures. The subject guides are intended for the total knee arthroplasty procedures and represent a combination of design and functionality of those in K102795 and K110415. The Vanguard XP-CR tibial tray will utilize the guides cleared in K102795/K110415 as they have the same profile/bone interface as the predicates. The Vanguard XP-XP tibia guide have similar vertical cut slots as partial tibia guide in K110415. The vertical cut-through slots allow for preliminary cuts of the bone, before final cuts are made and the implant is placed.

Here's a breakdown of the acceptance criteria and the study information for the Signature Personalized Patient Care System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Information

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

   • Test Set Sample Size: Two cadaveric trials were used for accuracy performance testing.
   • Data Provenance: The document does not specify the country of origin for the cadaveric trials. It's a non-clinical study, so "retrospective or prospective" designation isn't directly applicable in the same way it would be for patient data.

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the cadaveric trials. Given that the study involves "accuracy performance testing," the ground truth would likely be based on precise physical measurements of instrument placement, rather than expert interpretation of images.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method. For cadaveric accuracy testing, the "ground truth" would be established through direct measurement and comparison to the pre-operative plan, rather than expert consensus on interpretations.

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

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on non-clinical testing (software validation, cadaveric trials for accuracy, guide deformation, and debris rationale). The submission states "Clinical data: Not applicable."

5. Standalone (Algorithm Only) Performance Study:

   • Yes, a standalone performance study was done for the software compomenent, though not described in detail. The "Signature Planner software has been validated for its intended use" indicates a standalone assessment of the software's capabilities to generate a pre-operative plan. The subsequent cadaveric trials would then integrate this software's output with the physical guides.

6. Type of Ground Truth Used:

   • For the software validation, the ground truth would likely be based on predefined anatomical landmarks and measurements.
   • For the cadaveric trials, the ground truth for accuracy would be based on direct physical measurements (e.g., using a coordinate measuring machine or similar precision tools) to compare the actual placement of the guides/cuts with the pre-operative plan generated by the Signature Planner software.

7. Sample Size for the Training Set:

   • The document does not specify a sample size for a training set. The device is described as inheriting functionality from previously cleared devices (K102795 and K110415) and adapting for new implant systems. Software validation often involves internal testing against specifications rather than a separate "training set" in the machine learning sense, especially for earlier medical device software.

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

   • Not applicable, as a distinct training set (in the machine learning context) with established ground truth is not described in the document. Software validation typically involves testing against predefined output specifications and adherence to design requirements, rather than a separate training process for an algorithm that learns from data.

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The Signature™ Personalized Patient Care System – Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.

The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.

The Signature™ guides are intended for single use only.

The Acetabular Guide System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the orientation of an acetabular cup.

The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with the following Biomet acetabular systems and their respective compatible components: Bio-Clad™ All-Poly Cup (K810120 and K926107), Ranawat/Burstein™ All-Poly Cup (preamendment), RX-90™ Low Profile Shell (K920639 and K042989), Full Hemisphere Shell (K920640), Mallory/Head™ Shells (K861114, K921181, and K030055), Quadrant Sparing Shells (K920640 and K050124), Ranawat/Burstein™ Shells (K911685, K921277, and K050124), Regenerex™ Porous Titanium Shells (K052996), Regenerex™ Ringloc+ Shell System (K070369), Ringloc+ Acetabular System (K070369), Tri-Spike Pegged Shells (K970501 and K030055), Tri-Polar Shell (K991990), Universal Shells (K861433, K921301, and K030055), Vision™ Shells (K954417 and K030055), Freedom™ Constrained All-Poly Cups (K030047), M2a-Magnum™ with E1™ Active Articulation (K101336), and M2a-Magnum™ with ArComXL™ Active Articulation (K110555).

Here's a breakdown of the acceptance criteria and study information for the Signature™ Planner and Signature™ guides, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a quantitative format (e.g., "accuracy > 95%"). Instead, it describes general performance requirements that were met.

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

The document states: "Accuracy performance testing and guide dimensional stability testing was performed to determine substantial equivalence."

• Sample Size: The sample size for the test set is not specified in the provided text.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.

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

This information is not provided in the text. The document refers to "Accuracy performance testing" but does not detail the methodology for establishing ground truth for this testing.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1, none) for the test set is not specified in the provided text.

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

No, an MRMC comparative effectiveness study was not done or reported. The document states, "Clinical data: Not applicable." This indicates that no human reader studies (MRMC or otherwise) were performed and submitted.

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

Yes, a standalone study was done. The "Accuracy performance testing" and "guide dimensional stability testing" described are typical of standalone, algorithm-only performance evaluations for devices like this. The device is a "software component, Signature™ Planner and a hardware component, Signature™ guides," which implies the software's performance (planner) and the physical guide's performance (accuracy of transfer) were tested.

7. The Type of Ground Truth Used

The type of ground truth used is not explicitly stated beyond "Accuracy performance testing." For a device assisting in surgical orientation, typical ground truth for such testing would involve:

• Manufacturing tolerances/specifications: for the guides.
• Precision measurement tools: to verify the accuracy of the planned orientation transferred by the guides to a physical model or cadaver.
• High-resolution imaging or coordinate measuring: to establish true anatomical landmarks and compare against the device's output.

However, the specific methodology is not detailed.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about it. Given that this is a 510(k) submission for a device that generates patient-specific guides based on MRI data, the "training" aspect is more likely to be related to the development and validation of the algorithms and manufacturing processes, rather than a separate "training set" of patient data in the context of machine learning. The focus here is on the accuracy of the planning and guide manufacturing.

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

Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is also not provided.

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

The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.

The Signature™ guides are intended for single use only.

The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size for the test set. It mentions "cadaveric trials" for accuracy performance testing.

The data provenance is from cadaveric trials, which implies a pre-clinical, non-human source. The country of origin is not specified. It is a retrospective study in the sense that cadavers are used for testing, but given the nature of the device (surgical planning and guidance), it implies a pre-clinical evaluation phase.

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

The provided text does not specify the number of experts used to establish ground truth or their qualifications for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's standalone accuracy and performance, not on its impact on human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done for the algorithm. The text states: "The Signature™ Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices." and "...accuracy performance testing by means of cadaveric trials...was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended." This indicates the software and guides were tested for their inherent accuracy and performance.

7. Type of Ground Truth Used

The ground truth for the in-vitro performance was established through cadaveric trials for the surgical guidance accuracy. For the software validation, it's implicitly against established engineering and computational standards for accuracy, though the exact method isn't detailed.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set. The device description points to it being a software that generates plans based on MRI imaging data, implying an underlying algorithm that would likely have been trained, but no details are given.

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

The provided text does not describe how the ground truth for the training set was established.

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Signature™ Personalized Patient Care 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 Signature™ Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system.

The Signature™ guides are intended for single use only.

Signature тм Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of total knee replacement components.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it refers to validation against intended use and substantial equivalence to predicate devices. The performance is broadly stated as "adequate."

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

• Test Set Sample Size: The text states "cadaveric trials" were performed. However, it does not provide a specific number or range of cadavers used for these trials.
• Data Provenance: The cadaveric trials imply a prospective data collection for the performance testing. The country of origin for the cadavers is not specified.

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

The document does not mention the use of experts to establish ground truth for the CADAVERIC test set. The evaluation appears to be based on direct measurement of device output (e.g., pin placement accuracy). If human judgment was involved, it is not detailed.

4. Adjudication Method for the Test Set

As the document does not detail the use of experts or a subjective assessment for the test set's ground truth, an adjudication method is not described. The assessment seems to be based on objective measurement during the cadaveric trials.

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

No, an MRMC comparative effectiveness study was not mentioned in this 510(k) summary. The device, Signature™ Planner, is a software for pre-surgical planning and the Signature™ guides are patient-specific templates. The focus is on the accuracy of these tools directly, not on improving human reader performance with AI assistance.

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

Yes, in spirit. The "Signature™ Planner software... has been validated for its intended use" and "Accuracy performance testing by means of cadaveric trials" was performed. While a surgeon uses the software to "inspect, fine-tune and approve the pre-surgical plan," the performance testing described seems to primarily evaluate the system's (software + guides) ability to accurately transfer the plan to the physical space (cadaver) without explicitly measuring the impact of human fine-tuning on the accuracy results reported in the cadaveric trials. The accuracy reported ("adequate") is the outcome of the system's ability to produce precise pin locations.

7. The Type of Ground Truth Used

The ground truth for the cadaveric trials would likely be established through direct, precise measurement of the actual pin placements on the cadaveric bones relative to the intended pre-surgical plan. This would involve highly accurate measurement techniques (e.g., CMM, optical tracking, or high-resolution CT scans of the cadaver after pin insertion) to determine the deviation from the planned positions. This falls under objective physical measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is typical for medical device submissions focusing on predicate pathway and substantial equivalence, especially for technologies predating the widespread use of deep learning models that require large training datasets. The "Signature™ Planner" likely relies on established geometric algorithms and imaging processing techniques rather than a machine learning model that requires a distinct training phase with labeled data.

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

As no training set is mentioned (see point 8), no information is provided on how its ground truth would have been established.

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