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The Precice Intramedullary Limb Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatic patients (greater than 12 years old).

The predicate system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The purpose of submission is to add the treatment of pediatric patients (greater than 12 years old) to this the Precice Intramedullary Limb Lengthening System indications for use. The Precice Intramedullary Limb Lengthening System includes the same devices as within the predicate Precice System (K172628) : nail, cortical screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, in K113219; ERC 2P, in K131490; or ERC 3P, in K170169; or ERC 4P, in K191336). The configurations of sets and geometry of previously cleared Precice System devices remain unchanged. The following system description is herein repeated from K172628: Precice Nail is available in various designs, lengths, and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The screws are also available in a variety of different lengths and thread styles. The ERC is available in several compatible models, including the ERC 1, ERC 2P, ERC 3P and ERC 4P. The subject device components are manufactured from medical grade titanium alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Precice IMLL nail is implanted using locking screws and reusable surgical instruments.

The provided text describes a 510(k) submission for the Precice Intramedullary Limb Lengthening System, primarily focusing on expanding its indications for use to include pediatric patients (greater than 12 years old). It does not contain information about an AI/ML-driven medical device, an MRMC comparative effectiveness study, or details related to establishing ground truth by a panel of experts for a test set. Therefore, I cannot fully address all the points in your request.

However, I can extract information related to the device's acceptance criteria, study design, and performance data as presented for its 510(k) clearance. The "acceptance criteria" here are not explicitly stated in numerical thresholds, but are demonstrated through substantial equivalence to predicate devices and performance data from clinical literature and a retrospective study.

Here's a breakdown of the available information structured to best fit your request:

Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through comparison with predicate devices and clinical outcomes from two pediatric datasets (literature review and retrospective study) and one adult literature dataset. The implied acceptance criteria are that the device performs comparably or acceptably for limb lengthening, with acceptable rates of adverse events and bone healing.

Table of Reported Device Performance

Since this is not an AI/ML device with specific classification metrics, the "acceptance criteria" are implied by the comparison to predicate devices and the clinical outcomes themselves. The table below presents the key performance metrics reported in the submission.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Pediatric Literature Review: 227 patients with 253 lengthened bones (188 femur, 53 tibia, 12 humerus). Data provenance not specified beyond "clinical literature analysis of pediatric patients." It is a retrospective summary of published data.
   • Pediatric Retrospective Study: 59 patients (59 bones) treated in the United States with the Precice Intramedullary Limb Lengthening System. This is a retrospective study.
   • Adult Literature: 136 patients with 189 bones. Data provenance not specified beyond "clinical literature analysis." This is a retrospective summary of published data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable as the study involves a medical device for limb lengthening, not an AI/ML-driven diagnostic or image analysis tool requiring expert ground truth for a test set in the traditional sense of AI/ML validation. The "ground truth" for success/failure or adverse events would be derived from clinical outcomes and medical records.

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

   • Not applicable for the type of device and study described. Clinical outcomes are typically recorded directly from patient follow-ups and medical records, not through an adjudication process of interpretations by multiple experts.

4. 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 done. This type of study is specifically relevant for AI/ML-assisted diagnostic devices, which is not the case for the Precice Intramedullary Limb Lengthening System.

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

   • Not applicable. The device is a physical intramedullary limb lengthening system, not an algorithm. Its performance is directly tied to its use in patients by surgeons.

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

   • The "ground truth" for the device's performance is based on clinical and radiographic outcomes data from patients treated with the device, derived from both retrospective studies and aggregated literature. This includes achieved limb length, bone healing rates, and the incidence of various adverse events.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "evidence" presented supports the expansion of indications based on existing clinical data and the device's similarity to predicate devices.

8. How the ground truth for the training set was established:

   • Not applicable as there is no training set for an AI/ML model.

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

The 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, or ERC 3P). 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.

The third generation External Remote Controller (ERC 3P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 3P is an electrically powered handheld unit. The ERC 3P contains two large rare-earth magnets that are rotated using gears. After the PRECICE Nail has been implanted into the patient, the external device can be placed over the actuator portion of the nail and activated, the magnets within the ERC 3P rotate, which causes the magnet in the actuator portion of the PRECICE Nail to rotate, lengthening or shortening the nail. Periodic lengthening (typically daily) of the nail is performed after the implantation surgery to lengthen the limb. The ERC 3P also encompasses on-unit prescription programming. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis. The principles of operation of the ERC 3P are the same as those of the ERC and ERC2P previously cleared.

This FDA_510k document describes the PRECICE Intramedullary Limb Lengthening System, specifically focusing on the new External Remote Controller (ERC 3P). The document primarily focuses on establishing substantial equivalence to previously cleared devices through design, in vitro testing, software validation, and usability/labeling readability evaluations. Therefore, the information provided does not fully align with the typical structure of a study proving a device meets specific acceptance criteria in terms of accuracy or efficacy, but rather demonstrating safety and performance equivalence.

Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria for performance metrics related to limb lengthening accuracy, speed, or similar clinical outcomes as would be found in a study demonstrating efficacy. Instead, it lists various engineering and usability tests and standards used to demonstrate equivalence and safety of the ERC 3P.

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

• Test Set (Usability Study): 17 participants
• Data Provenance: The document does not explicitly state the country of origin for the usability study participants. It describes the study as being performed on a "representative population" and an "equivalent patient population," suggesting a prospective design within a clinical or simulated environment. It doesn't specify if it's retrospective or prospective, but usability studies are typically prospective.
• Other Testing: For the engineering tests (electrical safety, EMC, shock/vibration, etc.), the "sample size" is generally the device itself or a limited number of test units, which is standard for such evaluations. The data provenance would be from laboratory testing.

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

This information is not provided in the document. For the usability study, there isn't a "ground truth" established by experts in the context of diagnostic accuracy. Instead, the "truth" is the user experience and ability to perform tasks. Usability studies typically involve observers and evaluators, but they are not usually referred to as "experts" establishing a ground truth in the same way a radiologist establishes a diagnosis.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant to the nature of the usability study described. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers independently interpret data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth.

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

No, an MRMC comparative effectiveness study was not reported. The document focuses on demonstrating the substantial equivalence of the new ERC 3P to existing predicate devices (ERC and ERC2P) and confirming its safety and usability, not on comparing the efficacy of human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a medical hardware system (an intramedullary nail) with an external controller. It is not an AI algorithm or software-only device designed to standalone or diagnose. Therefore, a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The ERC 3P is a component that interacts directly with the patient and is operated by the patient.

7. The Type of Ground Truth Used

For the engineering tests, the "ground truth" is compliance with the specified standards (e.g., IEC 60601-1 for electrical safety). For the usability study, the "ground truth" is the successful and safe interaction of the participants with the device, and their ability to complete assigned tasks according to the device's intended use and design, as observed by the study team. It is not based on expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ERC 3P is a hardware device with software, not a machine learning model that requires a distinct "training set." Any internal software development or validation would involve standard software engineering practices, not a machine learning training set.

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

This information is not applicable as there is no "training set" in the context of machine learning. For software validation, the "ground truth" would be established by the software requirements and design specifications, verified through testing.

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

The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral 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, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with specific numerical targets. The "acceptance criteria" here are implied to be that the new device components (new screw thread styles) maintain the same or similar performance characteristics as the predicate device's existing components.

Study Information

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" for this submission. The document states that testing was previously performed on the predicate components and on the same screws used in a reference device (K160267). The specific number of screws or nails tested in those prior studies is not mentioned.
   • Data Provenance: Not explicitly stated. The document refers to prior testing, but doesn't specify the country of origin or if the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not mentioned. This submission focuses on engineering and biocompatibility testing (mechanical, pyrogen), not on clinical performance evaluated by experts with patient data.

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

   • Not applicable/None. As this is not a clinical study involving expert interpretation, there is no adjudication method.

4. 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 a medical device for bone lengthening, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

   • Not applicable. This is a physical implantable device, not an algorithm.

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

   • Ground Truth for Mechanical Testing: Adherence to established ASTM standards (material properties, strength, fatigue resistance, etc.) defining acceptable performance for orthopedic implants and screws.
   • Ground Truth for Pyrogen Testing: Compliance with ANSI/AAMI ST72:2011 specifications for bacterial endotoxins.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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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 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, 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 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 is a 510(k) summary for the PRECICE® Intramedullary Limb Lengthening System. It describes the device and claims substantial equivalence to previously cleared devices. However, it does not contain the detailed acceptance criteria and study data typically found in a clinical study report or a more comprehensive premarket submission.

Based on the provided text, here's what can be extracted and what information is not available:

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

The document presents in vitro mechanical testing for the device modifications. It doesn't explicitly state "acceptance criteria" as numerical thresholds that were met, but rather implies that the modifications were found substantially equivalent through these tests.

Missing Information: Specific numerical acceptance criteria and the actual numerical results from these tests are not provided in this summary. The statement "meet the performance specifications" is a general conclusion without supporting data.

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

This document describes in vitro mechanical testing, not a clinical study involving human subjects. Therefore, traditional "sample size," "test set," and "data provenance" as applied to clinical data are not directly applicable.

Missing Information: The number of devices or components tested for Static Torsion and Tensile Strength is not specified.

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 document details in vitro mechanical testing. The concept of "ground truth" established by human experts is not relevant to this type of testing. Engineering standards (ASTM F1264) are used for evaluation.

Missing Information: Not applicable.

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

This is not applicable to in vitro mechanical testing.

Missing Information: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a medical device, an intramedullary limb lengthening system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant.

Missing Information: Not applicable.

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

This is not applicable to an intramedullary limb lengthening system.

Missing Information: Not applicable.

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

For the in vitro testing, the "ground truth" would be the established engineering principles and standards (e.g., ASTM F1264) for evaluating the mechanical properties of a medical device.

Missing Information: While the standard is mentioned, specific numerical "ground truth" values for performance are not.

8. The sample size for the training set

This document describes in vitro mechanical testing for a physical medical device, not a machine learning model. Therefore, the concept of a "training set" is not applicable.

Missing Information: Not applicable.

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

Not applicable, as it's not a machine learning model.

Missing Information: Not applicable.

In summary: The provided text is a 510(k) summary focused on demonstrating substantial equivalence for modifications to an intramedullary limb lengthening system through in vitro mechanical testing. It does not contain the detailed clinical study data, ground truth establishment, or expert involvement typically associated with AI/diagnostic device evaluations. The reported "performance" is a general statement of meeting specifications rather than specific numerical results against defined acceptance criteria.

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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, ERC2P). The nail is available in tibia or femur models with 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 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 is a 510(k) premarket notification letter for the PRECICE® Intramedullary Limb Lengthening System and its associated 510(k) summary. It describes the device, its indications for use, and a demonstration of substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text with respect to your specific questions:

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

The document does not explicitly state acceptance criteria in a quantitative table format alongside performance results. Instead, it refers to general findings of "substantial equivalence" based on "in vitro testing" and "FEA Simulations."

• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance, as assessed by in vitro testing (tensile strength) and FEA simulations, is comparable to, and does not negatively impact, the safety and effectiveness demonstrated by the predicate devices. The phrase "meet the performance specifications" suggests that certain internal design specifications or established performance benchmarks were met, though these are not detailed.
• Reported Device Performance:
  • In Vitro Testing (Tensile Strength): The table lists "In Vitro Testing (Tensile Strength)" as a performed test. The conclusion section states "Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications." This indicates that the tensile strength of the modified nails was found to be acceptable and comparable to the predicate. No specific numerical performance values (e.g., specific tensile strength in MPa) are provided.
  • FEA Simulations: The table lists "FEA Simulations" as a performed test. Similar to the in vitro testing, the conclusion states that these simulations supported substantial equivalence and met performance specifications. No specific numerical results of the simulations (e.g., stress distribution, deformation values) are provided.

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

The document does not provide a sample size for any test set. The tests mentioned are "In Vitro Testing (Tensile Strength)" and "FEA Simulations," which are likely conducted in a lab environment rather than using patient data. Therefore, questions of retrospective/prospective and country of origin are not applicable in this context.

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 question is not applicable to the information provided. The study mentioned involves in vitro testing and finite element analysis (FEA) simulations, which are engineering and mechanical assessments, not clinical studies requiring expert ground truth for diagnostic or prognostic purposes.

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

This question is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth or interpret results. The study described here is focused on mechanical and engineering performance.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any indication that the device incorporates AI. This device is an intramedullary nail for limb lengthening, a mechanical implant.

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 (an intramedullary nail) and does not involve an algorithm working in a standalone capacity.

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

Since the "study" involves in vitro testing and FEA simulations, the "ground truth" would be established by the physical measurements from the in vitro tests (e.g., force-displacement curves for tensile strength) and the mathematical/computational results from the FEA simulations (e.g., stress and strain values calculated according to material properties and geometry). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this type of engineering assessment.

8. The sample size for the training set

This question is not applicable. The device is a mechanical implant, and the assessment involves direct testing and simulation. There is no "training set" in the context of an algorithm or machine learning.

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

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

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

The Ellipse PRECICE 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 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 modified 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 appears to be a 510(k) premarket notification for a medical device, specifically the Ellipse PRECICE® System, which is an intramedullary nail for limb lengthening. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical studies involving human patients as one might find for a new drug or complex diagnostic AI.

Therefore, many of the requested categories related to clinical studies, such as "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the loop performance)" are not applicable to this type of device submission as described in the provided text.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of in vitro (benchtop) engineering and performance tests as outlined in the provided text. These tests are conducted according to recognized industry standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1) and internal functional verification protocols. The purpose of these tests is to demonstrate that the modified Ellipse PRECICE System performs equivalently or superiorly to its predicate device and meets established safety and performance specifications.

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

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" as one would find in a clinical trial. For in vitro engineering tests, the sample size typically refers to the number of devices or components tested per condition. This information is not provided in the summary but would be detailed in the full test reports submitted to the FDA.
• Data Provenance: The data provenance is derived from in vitro laboratory testing conducted by Ellipse Technologies, Inc. There is no information regarding country of origin of data as it's not patient data. This is typically considered retrospective in the sense that the testing is performed on manufactured devices, not in a live patient setting.

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

• Not Applicable. For mechanical/functional testing of a medical device, "ground truth" is established by the specifications of the design, the chosen ASTM/ISO standards, and the capabilities of the testing equipment. There is no mention of human expert interpretation for establishing ground truth in these types of tests.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are relevant for subjective human interpretations, especially in clinical or image-based studies. This submission focuses on objective, quantifiable engineering test results.

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

• No. An MRMC study is relevant for diagnostic imaging devices where multiple readers evaluate cases. This is a limb lengthening implant, and its performance is evaluated through engineering tests, not human reader interpretation of clinical cases.

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

• Not Applicable. This is a mechanical implant with an external remote controller, not an algorithm-driven diagnostic or therapeutic device. "Standalone performance" in this context refers to the device's ability to lengthen, and its mechanical integrity, which is assessed through the engineering tests.

7. The Type of Ground Truth Used:

• The "ground truth" for this device, in the context of the provided information, is based on:
  • Validated engineering standards (ASTM F1264, ISO 11607-1, ISO 11137-2, ISO 10993-1): These standards define performance expectations and testing methodologies.
  • Predicate device performance: The modified device must demonstrate substantial equivalence or improvement compared to the previously cleared predicate device.
  • Device design specifications: Internal specifications for strength, functionality, and biocompatibility.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI, so there is no "training set." The development of the device is based on engineering design principles and material science, then validated through the specified in vitro tests.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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