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The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters. lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Nail is supplied sterile by gamma radiation while the locking screws and PRECICE surgical instruments are supplied non-sterile and must be sterilized prior to use.

This document is a 510(k) summary for the Ellipse PRECICE Intramedullary Limb Lengthening System (K160325). It is a letter from the FDA determining substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, focusing on the acceptance criteria and supporting studies. Please note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis typical of clinical trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or targets. Instead, it relies on demonstrating equivalence to a predicate device through various tests. The reported performance refers to the successful completion or comparability of these tests.

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

The document does not specify sample sizes for the mechanical tests (Static Torque to Failure, Device Functionality). For sterilization, shelf-life, and biocompatibility, it states these were "applicable" from the predicate device testing (K151131). The data provenance is implied to be from laboratory testing rather than human clinical data, and the type is retrospective as it relies on past predicate device testing and new tests specifically for the line extension. There is no mention of country of origin for the data, but it's presumed to be from Ellipse Technologies, an American company.

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

This information is not applicable as the document describes bench and mechanical testing, not a clinical study involving expert assessment of outputs for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench and mechanical testing.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intramedullary rod) and not an AI or imaging diagnostic device where such studies are typical. The focus is on mechanical and functional equivalence to a predicate device, not on diagnostic accuracy improvements or human reader performance.

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

Not applicable. This device is a physical medical implant and does not involve an algorithm or AI component in the typical sense of standalone performance evaluation.

7. The Type of Ground Truth Used

For the mechanical tests (Static Torque to Failure, Device Functionality, ASTM F1264), the ground truth is based on engineering standards and design specifications, ensuring the device performs as intended and withstands specified forces. For biocompatibility, sterilization, and shelf-life, the ground truth is established by validated laboratory methods and relevant industry standards/regulations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" would be used for algorithm development. The testing described focuses on validating the physical device's characteristics.

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

Not applicable for the reasons stated above.

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The Ellipse MAGEC® Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia® fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod includes an actuator portion that holds a small internal magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shortened.

The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to test the device prior to implantation. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back during a distraction procedure.

The provided document is a 510(k) summary for the Ellipse MAGEC® Spinal Bracing and Distraction System, focusing on the inclusion of a second-generation External Remote Controller (ERC 2). The submission aims to demonstrate substantial equivalence to a previously cleared MAGEC System (K140178).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or precision). Instead, it relies on demonstrating that the ERC 2 performs equivalently to its predicate device through design functionality, safety, and compatibility testing. The "reported device performance" is essentially the successful completion of these tests, showing the ERC 2 meets the standards set for medical devices of its type and performs as intended.

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

The document mentions "in vitro evaluations" and "non-clinical testing" for the ERC 2. It does not specify a "test set" in the context of patient data or clinical trials with a defined sample size. The testing described is primarily engineering and performance verification of the device components.

For the clinical performance data, the document states: "The retrospective clinical study performed on the MAGEC System and previously submitted is also applicable to the ERC 2 and this submission."

• Sample Size: Not specified in the provided text.
• Data Provenance: Retrospective, as explicitly stated. The country of origin is not mentioned.

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

This information is not applicable and not provided. The non-clinical testing for the ERC 2 focuses on engineering specifications and safety standards, not on diagnostic accuracy requiring expert interpretation of results. The previous retrospective clinical study supporting the MAGEC system (not the ERC 2 specifically) would have involved clinical assessments, but details on ground truth establishment and expert involvement are not in this document.

4. Adjudication Method for the Test Set:

Not applicable and not provided, as the testing described for the ERC 2 doesn't pertain to diagnostic accuracy where adjudication of expert opinions would be relevant.

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

No, an MRMC comparative effectiveness study is not mentioned in the context of this 510(k) submission. This submission focuses on the safety and performance of a device component (ERC 2) and its substantial equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.

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

This is not applicable to the device described. The MAGEC system is a physical implant and an external controller (ERC 2), not a standalone algorithm. The ERC 2 is a human-operated device used to interact with the implanted rod.

7. The Type of Ground Truth Used:

For the non-clinical testing of the ERC 2 (electrical, EMC, design verification, software validation), the "ground truth" is defined by the relevant engineering standards (EN ISO 14971, IEC 60601-1, IEC 60601-1-2) and FDA guidance for software. The device's performance against these established benchmarks serves as the "truth." For the retrospective clinical study mentioned, the type of ground truth used is not specified in this document, but would typically involve clinical outcomes or expert diagnoses.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The ERC 2 is a hardware device with embedded software, not a machine learning model that requires a "training set" in the conventional sense of AI development.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

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The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.

This document describes the PRECICE Trauma Nail System, which is an intramedullary nail for fixing long bone fractures, pseudoarthrosis, mal-unions, and non-unions. The submission is a Special 510(k) focusing on modifications to an already cleared predicate device (PRECICE Trauma Nail System, K113695).

Based on the provided text, the device itself is a mechanical intramedullary nail system and thus the studies performed are not human-in-the-loop AI studies, nor does the device rely on AI/ML, algorithms, or data for ground truth establishment. Instead, the studies are focused on demonstrating the mechanical and functional equivalence of the modified device to its predicate.

Here's an analysis based on the provided text, with clarifications where the requested information is not applicable to this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, etc.). The "performance" here refers to the physical and functional attributes of the modified nail.

Study Details:

The study described is not a clinical trial or an AI/ML performance study. It's a benchtop and engineering study demonstrating that the modifications to the PRECICE Trauma Nail System (specifically, adopting design changes from the PRECICE Intramedullary Limb Lengthening System and adding an 8.5mm diameter) do not alter the substantial equivalence to the previously cleared predicate PRECICE Trauma Nail System. The core studies (mechanical, design verification, magnetic field safety, packaging/shelf-life, sterilization, biocompatibility) were performed on the referenced PRECICE Intramedullary Limb Lengthening System, and these results were deemed applicable because the modified PRECICE Trauma Nail is identical in design to the PRECICE Nail in that system, with the only difference being the pre-distraction feature.

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

• Sample Size: Not applicable in the context of "test set" for data-driven AI/ML models. The "test set" here refers to the actual physical devices (or components) subjected to various engineering and performance tests. The document doesn't specify the exact number of nails or components tested, but it implies standard engineering testing practices where a sufficient number of samples are used to ensure statistical confidence in results (though specific numbers aren't provided in this summary).
• Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective clinical data for AI/ML. The "data" comes from laboratory and benchtop testing of the specific medical device components.

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

Not applicable. "Ground truth" in this context is established by engineering specifications, validated test methods, and regulatory standards for mechanical and material performance, not by expert consensus on clinical findings. The evaluation is done by engineers and scientists, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" in an engineering context would refer to internal validation and review processes by qualified engineers to ensure test protocols were followed and results were interpreted correctly, but this is not typically detailed in 510(k) summaries in the same way as clinical adjudication.

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 not an AI/ML device and does not involve human readers or image interpretation.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering specifications, material properties, and performance standards for intramedullary fixation rods. For example, the ground truth for mechanical testing would be the breaking point, fatigue life, or magnetic field compatibility as defined by relevant ISO or ASTM standards, and comparative performance to the predicate device's established performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth.

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The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters. Iengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet. telescoping lead screw/nut assembly, and planetary gearing.

This document describes the Ellipse PRECICE Intramedullary Limb Lengthening System and its substantial equivalence to a previously cleared device. The focus of the provided text is on demonstrating the device's safety and effectiveness through mechanical and functional testing, rather than clinical study results involving human readers or comparative effectiveness studies with AI.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance values for the modified device in a table format. Instead, it describes tests performed to establish equivalence to predicate devices, implying that the modified device met the performance of those predicates. The "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications" suggests that the device passed these tests according to predefined specifications, which are not detailed in the text.

Note: "Met specifications" in the "Reported Device Performance" column is inferred from the statement "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications." The specific numerical results or detailed performance metrics are not provided in this submission summary.

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

The provided text details mechanical and functionality testing for a medical device (an intramedullary nail), not a medical imaging or diagnostic device that would typically use human test sets or patient data with a "sample size" in the context of clinical studies. Therefore, this question is not applicable to the type of safety and efficacy evidence presented. The "test set" here refers to the device prototypes or components undergoing mechanical stress tests. The data provenance is laboratory testing conducted by Ellipse Technologies, Inc. No information on country of origin of the data or retrospective/prospective nature is relevant for these in vitro tests.

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

This question is not applicable. The "ground truth" for mechanical and functional testing of a medical device like an intramedullary nail is established by engineering specifications, international standards (e.g., ASTM F1264-03), and comparison to predicate devices, not by medical experts interpreting results from a test set in a diagnostic context.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials or diagnostic studies to resolve discrepant expert opinions on patient data. The current document describes in vitro engineering tests.

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

This question is not applicable. The device described is a physical implant (intramedullary nail) for limb lengthening, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study involving AI assistance is mentioned or relevant to this type of device.

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

This question is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical and functional testing, the "ground truth" is based on:

• Established engineering standards: ASTM F1264-03 for Static/Dynamic Four Point Bend and Static Torque to Failure.
• Performance of predicate devices: The modified device's performance is compared to that of previously cleared Ellipse PRECICE Systems (K131677 and K133289) to demonstrate "substantial equivalence." This implies that the predicate devices' established safety and performance serve as the "ground truth" for the modified device.
• Internal design specifications: For tests like "Magnet Holding Torque" and "Device functionality and verification" where no external standard is cited, the ground truth would be the device's own design specifications, validated through testing.

8. The Sample Size for the Training Set

This question is not applicable. The context is not machine learning or AI, so there is no "training set." The testing involved physical prototypes or samples of the device.

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

This question is not applicable, as there is no "training set" in this context.

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The Ellipse MAGEC Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.

The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium rod (Ti-6Al-4V ASTM F136) includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shorten.

The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to test the device prior to implantation. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC rod. The ERC is placed over this location on the child's back.

The provided text describes the MAGEC® Spinal Bracing and Distraction System and its premarket notification (K140178) to the FDA. The submission focuses on establishing substantial equivalence to a predicate device, the Harrington Rod System, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic AI product.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and detailed ground truth establishment for training) cannot be extracted from the provided document as it pertains to a mechanical medical device rather than a diagnostic AI.

However, I can extract information related to the device's performance evaluation.

Here's the information that can be extracted and a clear statement about what cannot:

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

The document does not provide a table of numerically defined acceptance criteria for a diagnostic AI product. Instead, it describes performance in terms of mechanical and clinical outcomes for a spinal bracing system.

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

• Test Set Sample Size:
  • In Vivo (Animal) Study: 9 male Yucatan pigs (randomly assigned to two groups: 1 (MAGEC rod) and 2 (sham)).
  • Clinical Study: Not explicitly stated, but described as a "retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System."
• Data Provenance:
  • In Vivo Study: Porcine model (animal study).
  • Clinical Study: "evaluated outside the United States" (retrospective).

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)

This information is not provided in the document. The studies performed were primarily in vivo animal studies and a retrospective clinical study focusing on device performance and clinical outcomes, not on establishing ground truth for a diagnostic AI.

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

This information is not provided as it is not relevant to the type of device and studies 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

This information is not provided as it is not relevant to the type of device (spinal bracing system) and evaluation presented. It's a study design typically used for diagnostic imaging AI.

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

This information is not provided as it is not relevant to the type of device described, which is a physical, implantable medical device, not a standalone diagnostic algorithm.

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

• Non-Clinical and In Vivo Studies: Ground truth was based on physical measurements, functional specifications, and observation of physiological responses (e.g., distraction achieved, lack of complications) in controlled experimental settings.
• Clinical Performance Data: Ground truth or "probable benefit" was assessed based on clinical outcomes data such as Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in subsequent surgical procedures, and weight gain.

8. The sample size for the training set

This information is not provided as there is no mention of a "training set" in the context of an AI/algorithm-based device. The device is mechanical with non-invasive magnetic actuation.

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

This information is not provided as there's no training set for an AI in this context.

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The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of an implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

The provided document, K131490, describes the Ellipse PRECICE® System, specifically focusing on the second-generation External Remote Controller (ERC 2P). This submission aims to demonstrate substantial equivalence to previously cleared devices (K101997 and K113219) rather than introducing a new clinical indication or demonstrating a novel clinical performance through a standalone study.

Therefore, the acceptance criteria and study details discussed below are primarily focused on the usability, safety, and performance of the ERC 2P in demonstrating equivalence to its predicate, not on the clinical effectiveness of the limb lengthening system itself.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Usability Study: 15 participants.
• Data Provenance: The document does not explicitly state the country of origin for the usability study participants. Given the company (Ellipse Technologies, Incorporated) is based in Irvine, California, USA, and the submission is to the FDA, it is highly probable the study participants were from the USA or North America. The study was prospective for the usability evaluation, as it was specifically undertaken to evaluate the ERC 2P. Other tests (electrical safety, EMC, etc.) are laboratory-based and not patient-data dependent in this context.

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

For this type of submission (focused on a new controller for an existing system), "ground truth" isn't typically established by medical experts in the way it would be for a diagnostic AI algorithm.

• Usability Study: The "ground truth" for the usability study was the observed performance and feedback from the 15 participants using the ERC 2P in a simulated home environment, evaluated against pre-defined usability tasks and criteria. The document states a "representative population" was used, which implies users matching the demographic and cognitive profile of the actual patient users.
• Other Tests (Safety, Performance): The "ground truth" for these tests (e.g., electrical safety, EMC, shock/vibration) is defined by the standards themselves (e.g., IEC 60601-1). The "experts" involved would be qualified test engineers and technicians performing the tests and interpreting the results against established regulatory standards.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for this submission.

• For the usability study, the "adjudication" would involve human factors specialists or researchers observing participant interactions, collecting quantitative and qualitative data (e.g., task completion rates, errors, subjective feedback), and interpreting this data against usability goals. There isn't a "2+1" or "3+1" medical expert adjudication method described or typically used for usability studies of this nature.
• For laboratory tests, compliance with standards is usually a pass/fail determination, sometimes with detailed reports and expert review of those reports by test house engineers or regulatory affairs professionals, but not "adjudication" in the multi-reader sense.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This submission is for a new version of an external controller for a mechanical medical device, not a diagnostic imaging AI algorithm. Therefore, improving human reader performance with or without AI assistance is not relevant to this device's function or the scope of this 510(k) submission.

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

Not applicable in the context of an "algorithm only" performance.

The device (ERC 2P) is an interactive electromechanical device. While it has embedded software and a camera to assist alignment, its primary function is to enable the patient to non-invasively lengthen the implantable rod under physician prescription. Its performance is inherently "human-in-the-loop" due to the user activating it and ensuring proper alignment. The usability study evaluated this human-in-the-loop performance.

7. The Type of Ground Truth Used

• For safety and performance tests (electrical, EMC, shock/vibration, ingress protection): Compliance with recognized international standards (e.g., IEC 60601 series) served as the ground truth.
• For the usability evaluation: The ground truth was based on observed user performance, task completion, error rates, and subjective user feedback against pre-defined usability goals and criteria.

8. The Sample Size for the Training Set

Not applicable.

Because this is a submission for a hardware device (an external controller) with embedded software, not a machine learning or AI algorithm in the contemporary sense that would require a "training set" of data to learn from. The software in the ERC 2P is deterministic and programmed, not "trained."

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

Not applicable. (See answer to #8). There was no "training set" in the context of machine learning. The device was developed and tested against engineering specifications, risk analyses, and recognized standards.

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The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific accessories are supplied non-sterile and must be sterilized prior to use. The nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing.

The Ellipse PRECICE® System, specifically the 8.5 mm PRECICE Nail and its associated 3.5 mm diameter locking screw, obtained 510(k) clearance (K133289) based on its substantial equivalence to a previously cleared device, the Ellipse Intramedullary Limb Lengthening System (K131677). This clearance was supported by non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The document explicitly states that "Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. Where specific dimensional differences exist, bench testing has shown that these differences do not present new risks." This implies that the acceptance criteria for these tests were to demonstrate performance at least equivalent to, or not presenting new risks compared to, the predicate device (K131677). The reported performance is that the tests were performed and the device was found to be "as safe, effective, and performs as well as the predicate device (K131677)."

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

• Sample Size: The document does not specify a distinct "test set" in terms of patient data. The evaluation was primarily based on mechanical testing and design functionality/performance testing of the device components (nail and screws). Therefore, the "sample size" would refer to the number of devices or components tested in these benchtop studies. This information is not provided in the given text.
• Data Provenance: The data provenance is non-clinical bench testing. The country of origin of the data is not explicitly stated, but the company is U.S.-based (Irvine, CA), and the submission is to the U.S. FDA, suggesting the testing was likely conducted in the U.S. or at a facility that meets U.S. standards. The data is retrospective in the sense that it's laboratory testing, not prospective patient data.

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

This question is not applicable to this submission. The "ground truth" for this medical device clearance was established through objective engineering standards and mechanical testing, not expert consensus on patient data. No human experts were used to establish ground truth for a "test set" in the context of clinical performance.

4. Adjudication Method for the Test Set

This question is not applicable as there was no "test set" requiring human adjudication as would be found in a clinical study for diagnostic devices. The acceptance was based on direct comparison of mechanical properties and design features to a predicate device.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic imaging device that would typically undergo such a study. The evaluation focused on mechanical and functional equivalence.

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

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on objective performance metrics from mechanical testing conducted according to ASTM standards (F1264-03, F543-07) and a comparison to the known performance and design of a legally marketed predicate device (K131677). Essentially, the ground truth was "does this new device perform at least as well as the predicate device on established engineering tests, and does it introduce any new risks?"

8. The Sample Size for the Training Set

This question is not applicable. There was no "training set" in the context of machine learning or AI algorithms. The submission is for a medical device (intramedullary nail).

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

This question is not applicable for the same reason as #8.

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The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use. The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod. The ERC can be used by the physician or by the patient in the home environment to perform lengthening.

Here's a breakdown of the acceptance criteria and study information for the Ellipse PRECICE Intramedullary Limb Lengthening System, based on the provided text:

Key Finding: This 510(k) submission (K113219) is primarily focused on the Home Use of the External Remote Controller (ERC) by the patient and claims substantial equivalence to a previously cleared device (K101997). Therefore, the "acceptance criteria" and "study" largely revolve around the usability and safety of the ERC in a home setting.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy metrics for limb lengthening). Instead, the acceptance is based on demonstrating the ERC's suitability and safety for home use through various tests and a usability evaluation, establishing substantial equivalence to the predicate device.

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

• Sample Size for Usability Study: 30 subjects.
• Data Provenance: The document does not specify the country of origin for the usability study data. It also does not explicitly state if the study was retrospective or prospective, but a usability evaluation on "subjects" typically implies a prospective study.

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

Not applicable for this submission. The "ground truth" for the usability study would be the participants' ability to safely and effectively use the ERC in a simulated home environment, as assessed by evaluators, rather than expert interpretation of medical images or data. No mention of "experts" in this context is made beyond the manufacturer's internal team conducting the evaluation.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert consensus for medical data. The usability study would have its own methodology for evaluating participant performance and feedback, but it's not described as an "adjudication method" involving independent experts for ground truth.

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 limb lengthening system with an external controller, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists).

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

This question is not directly applicable. The "standalone" component here is the ERC itself. The usability study is evaluating the human using the ERC for "human-in-the-loop performance" in a home setting. The device's primary function (limb lengthening) is mechanical and controlled by the ERC, so the concept of an "algorithm only" performance separate from the human interaction with the ERC doesn't fit this device type.

7. The Type of Ground Truth Used

For the usability evaluation, the "ground truth" would be the direct observation of users interacting with the ERC and their ability to successfully and safely operate it according to instructions, as well as their subjective feedback. This falls under usability data/user performance data. For the other technical tests (voltage, shock, ingress protection), the "ground truth" is adherence to and successful completion of the specified IEC standards.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this 510(k) submission, which focuses on hardware and a usability study, not on developing a machine learning algorithm.

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

Not applicable, as there is no training set for an algorithm.

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The Ellipse PRECICE Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The PRECICE Actuator is supplied sterile by gamma sterilization while the PRECICE Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use. The External Remote Controller (ERC) is a non-invasive adjustment component of the system. The ERC is electrically powered and is used for non-invasive lengthening of the implanted rod.

I am sorry, but the provided text does not contain information regarding acceptance criteria or details about a study that proves the device meets acceptance criteria.

The document is a 510(k) summary for the Ellipse PRECICE Trauma Nail System, primarily focusing on:

• Product Description: What the device is and its components (intramedullary rod, locking screws, external remote controller).
• Indications for Use: What the device is intended for (closed fracture fixation, pseudoarthrosis, mal-unions, and non-unions of long bones).
• Substantial Equivalence: How the device is similar to previously cleared devices (predicates) and therefore deemed safe and effective. It explicitly states that the purpose of the premarket notification is to provide labeling for fracture fixation and that substantial equivalence is based on similar indications and technological characteristics.
• FDA Clearance Letter: Official communication from the FDA confirming the 510(k) clearance based on substantial equivalence.

There is no mention of specific acceptance criteria, test results, device performance metrics, or study designs to prove that the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets.

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The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

The Ellipse Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm in 5 mm increments. The distracting rod is a modular system that includes the IMLL Actuator component and various configurations of IMLL Extension Rods. The IMLL Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The IMLL Actuator is supplied sterile by gamma sterilization while the IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.

The provided text does not contain detailed acceptance criteria with numerical thresholds, nor does it present specific performance metrics from a study that directly proves the device meets such criteria to the extent that would typically be seen in a clinical trial or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through various forms of in vitro testing and a comparison of technological characteristics. The "performance" in this context refers to the device successfully passing a series of mechanical, sterilization, biocompatibility, and electrical safety tests, rather than a clinical performance measured against specific clinical acceptance criteria.

Here's an analysis based on the provided text:

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

The document lists several tests performed to establish substantial equivalence. While it doesn't explicitly state "acceptance criteria" with numerical values used in the studies, the implicit acceptance criterion for each test is successful completion and compliance with the specified standard.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes used for each of the mechanical or other in vitro tests. It refers to "testing" performed.
• Data Provenance: The tests are in vitro tests performed on the device components, not on human or animal subjects. Therefore, there is no country of origin of data or distinction between retrospective/prospective in the clinical sense. These are laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the type of testing described. The "ground truth" here is the pass/fail criteria defined by the applicable test standards (e.g., ISO, ASTM, IEC). Evaluation of test results against these standards is typically done by engineers or quality control personnel, not medical experts establishing a clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts independently evaluate cases and then resolve discrepancies. The tests mentioned are objective engineering and material science tests, not subjective interpretations requiring medical adjudication.

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:
This is not applicable. The device is a mechanical intramedullary limb lengthening system, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant with an external remote controller, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed is the compliance with recognized international and national standards (e.g., ISO, ASTM, IEC) for mechanical properties, sterility, biocompatibility, electrical safety, and software validation. For the magnetic field safety, it refers to "established safety guidelines." There is no clinical ground truth (like pathology or outcomes data) derived from human subjects for these substantial equivalence tests.

8. The sample size for the training set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set.

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