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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 Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle:

Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time

The the worst case validated sterilization load is:

-One (1) Supplemental Instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 lbs.); in a non-stacked configuration.

The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:

Supplemental Instrument Tray (Model SIT1-000)

The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:

Supplemental Reamer Tray (Model SRT1-000):

Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray. Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.

The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a Supplemental Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth), and is designed to hold 12 instruments. The Supplemental Reamer Tray has the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth), and is designed to hold 18 flexible reamer instruments. An insert tray with the following dimensions is used with the Supplemental Reamer Tray: 497 mm (length) x 240 mm (width) x 52 mm (depth). The Ellipse Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade, Class VI Silicone.

The document provided describes the Ellipse Supplemental Instrument Trays and their intended use for organizing, protecting, and transporting instruments during steam sterilization. It also details the performance testing conducted to demonstrate their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single consolidated table of all acceptance criteria with corresponding performance results in a formal way. Instead, it discusses various validation tests and their outcomes. I've extracted the relevant information and organized it into the following table, synthesizing acceptance criteria from the descriptions of the tests performed.

2. Confirmation of the absence of moisture on the trays and sterilization wrap.
3. No more than 3% difference in weight prior to and after sterilization. (for 40 minutes dry time) | Met: "The dry time validation was successful in determining an effective dry time of 40 minutes for the validated pre-vacuum steam sterilization cycle. Acceptance criteria below were met during validation of the dry time: 1) Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle; 2) Confirmation of the absence of moisture on the trays and sterilization wrap; 3) No more than 3% difference in weight prior to and after sterilization." |
   | Material Durability | Function and physical construction of trays and components maintained after 100 sterilization cycles. | Met: "Performance testing was conducted to demonstrate that the function and physical construction of the Ellipse Supplement Trays and its components are maintained after exposure to 100 sterilization cycles."
   "The materials used in the Ellipse Supplemental Instrument Trays were exposed to 100 sterilization cycles and no material degradation was observed. All materials maintained their integrity and remained fully functional." |
   | Material Compatibility | Materials of construction are compatible with steam sterilization. | Met: "Performance testing demonstrated that the materials of construction are compatible with steam sterilization." |
   | Biocompatibility | Materials of construction are biocompatible (non-cytotoxic). | Met: "Extracts of test article (polymeric component) on L-939 mouse fibroblast cells in MEM elution assay did not display a cytotoxic response and is considered non-cytotoxic. Testing demonstrated that the materials of construction are biocompatible." |
   | Shipping Validation | All acceptance criteria for package performance testing were met. | Met: "Shipping validation was performed on the Ellipse Supplemental Instrument Trays. The package performance testing results demonstrated all acceptance criteria were met." |
   | Cleaning Validation | Hemoglobin, Micro BCA protein, and TOC test results meet all acceptance criteria for both manual and automated cleaning processes. | Met: "The Ellipse Supplemental Instrument Trays have been validated to be cleaned using both a manual and automated process. Hemoglobin, Micro BCA protein, and TOC test results met all acceptance criteria." |

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

The document does not explicitly state a "test set" in the context of an AI/algorithm. This device is a physical medical instrument tray, not a software algorithm. Therefore, the concept of a "test set" for data provenance, country of origin, or retrospective/prospective data as typically used for AI/ML models does not apply here.

For the physical device, the "samples" would be the trays and instruments themselves. The performance testing mentions:

• 100 sterilization cycles for material durability. This implies that the trays were subjected to at least 100 cycles to assess their physical integrity and functionality.
• Worst-case validated sterilization load: This involved one (1) Supplemental Instrument Tray (10.0 lbs) and one (1) Supplemental Reamer Tray (13.1 lbs) in a non-stacked configuration, loaded with specific instruments (12 in the Instrument Tray, 18 in the Reamer Tray), including those with worst-case lumen dimensions.

The provenance of the data would be from laboratory testing performed on the physical trays and associated instruments.

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

This question is not applicable as the device is a physical instrument tray, not an AI/ML model for which "ground truth" would be established by experts. Performance is determined by objective physical and biological tests (e.g., SAL, material integrity, dryness, cleaning efficacy).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for evaluating human-expert disagreement for ground truth in AI/ML studies. For a physical device, performance is measured against predefined objective standards and test results.

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

Not applicable. This is a physical medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

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

7. The Type of Ground Truth Used

As this is a physical device, the "ground truth" for its performance is established by objective laboratory and scientific testing against established standards and protocols. For example:

• Sterilization Efficacy: Measured by indicator organisms and testing to achieve a specific SAL (10⁻⁶). This is a microbiology-based ground truth.
• Dryness: Measured by the absence of visible moisture or weight difference, which are empirically verifiable physical properties.
• Material Integrity/Durability: Measured by physical inspection for degradation and functional testing after repeated cycles.
• Biocompatibility: Determined by in vitro cytotoxicity assays (e.g., L-939 mouse fibroblast cells).
• Cleaning Efficacy: Measured by chemical assays for residual contaminants (Hemoglobin, Micro BCA protein, TOC).

These are all objective, quantifiable measures rather than human expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.

8. The Sample Size for the Training Set

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

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

Not applicable. This device is not an AI/ML model.

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

The PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC or ERC 2P). The Nail is available in 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 Trauma Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-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 (femur and tibia models), 15 mm and 20 mm (humeral model) to allow for compression fracture reduction techniques.

This document is a 510(k) premarket notification for the "PRECICE Trauma Nail System" and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/medical device.

Therefore, the requested information (1-9) about acceptance criteria and study results cannot be extracted from this document, as it describes a clearance process for a medical device rather than a comprehensive performance study that would typically include such details.

Specifically:

• No acceptance criteria or device performance table is provided. The document states "Non-clinical testing of the PRECICE Trauma Nail System included design verification testing to ensure the device meets the retraction (compression) force and distraction force required for the humerus and cadaveric design validation testing to ensure the device can be inserted into the medullary canal and fixed to the humerus using the humeral specific instruments." This describes the types of tests performed, but not specific numerical acceptance criteria or the reported performance.
• No information on sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, or how ground truth for the training set was established is present. These details are typically found in clinical validation studies for diagnostic or AI-driven devices, which this is not.

The document primarily focuses on:

• Indications for Use: "The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones."
• Substantial Equivalence: The device is deemed substantially equivalent to the "PRECICE® Trauma Nail System" (K142599) based on "same indications for use, technological characteristics, principles of operation, designs, and on in vitro testing performed."
• Technological Characteristics: The device is described as a titanium intramedullary nail with a telescoping portion, an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing, adjusted non-invasively by an External Remote Controller (ERC).
• Non-clinical Testing: Mechanical testing (according to ASTM F1264-03), gamma radiation sterilization cycle validation (ISO 11137-2), shelf life testing, O-ring seal performance, and biocompatibility (ISO 10993-1) were performed on the predicate device and found applicable. Design verification and cadaveric design validation specific to the humeral models were also conducted for the current submission.

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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 MAGEC 2 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 MAGEC 2 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The implanted MAGEC 2 rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to noninvasively distract the implanted spinal rod. The titanium MAGEC 2 rod 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, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC 2 rod. 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 2 System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC 2 rod. The ERC is placed over this location on the child's back.

The provided document describes the FDA 510(k) clearance for the MAGEC 2 Spinal Bracing and Distraction System. This is a medical device designed to treat severe progressive spinal deformities in skeletally immature patients. The document focuses on demonstrating substantial equivalence to an existing predicate device (MAGEC Spinal Bracing and Distraction System, K140613), rather than outlining explicit acceptance criteria with numerical thresholds. Therefore, the "acceptance criteria" presented are implied by the comparison to the predicate and the general requirements for safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a medical device (spinal rod) and not a software algorithm with quantitative performance metrics like accuracy, sensitivity, or specificity, the "acceptance criteria" are related to mechanical performance, sterilization, and biocompatibility, as compared to the predicate device. The document states that the MAGEC 2 System is substantially equivalent to the predicate.

• Static Mechanical Testing (ASTM F1717-14)
• Dynamic Mechanical Testing (ASTM F1717-14)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Wear Testing | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Wear Testing (ASTM F2624-12)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Particulate Analysis | "wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Particulate Analysis (ASTM F1877-05)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Sterilization Efficacy | "validation of the gamma radiation sterilization cycle in accordance with the VDmag 22 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Sterilization Validation (ANSI/AAMI/ISO 11137-2)"
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Biocompatibility | "The performance testing on the predicate device includes... biocompatibility in accordance with ISO 10993-1 for the intended use of the device." (Implied to be met for the new device as well due to material similarity and predicate equivalence.) |
  | Design Verification | "design verification and validation."
  "The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
• Design Verification" (Standard not specified for Design Verification itself, but related to other standards.)
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Indications for Use Equivalence | "The MAGEC 2 System that is subject of this premarket notification and the predicate device have the same indications for use."
  "Substantial equivalence to the predicate device is based on indications for use..." |
  | Principles of Operation Equivalence | "Both the MAGEC 2 System and the predicate device are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both devices operate on the same non-invasive distraction technology using the Ellipse External Remote Controller (ERC or ERC 2)."
  "Substantial equivalence to the predicate device is based on... principles of operation..." |
  | Technological Characteristics Equivalence | "The technological characteristics of the subject device and the predicate device are similar. Both systems are manufactured of the same biocompatible metals and supplied sterile by the same methods of gamma radiation. The differences between the two systems include the addition of a 6.0 mm diameter rod to the product offering, design modifications to remove structural welds and new design features."
  "Substantial equivalence to the predicate device is based on... technological characteristics..."
  "Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate." |
  | Similar Safety and Probable Benefit as Predicate Device | "Previous clinical performance data for the predicate MAGEC System is applicable to the MAGEC 2 System."
  "The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study..." |

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

The document does not explicitly state a new test set sample size for the MAGEC 2 System for clinical performance. Instead, it relies on the clinical performance data of the predicate MAGEC System.

• Sample Size: Not specified for the predicate device's clinical study beyond "children."
• Data Provenance: "evaluated outside the United States in a retrospective clinical study."

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

This information is not provided in the document. The clinical study for the predicate device is described as a "retrospective clinical study," which would typically involve reviewing patient records, imaging, and outcomes. The "ground truth" for success in this context would be based on objective measurements (Cobb angle, thoracic spine height, SAL) and patient outcomes. It does not mention expert adjudication for establishing ground truth in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable/not specified. The clinical study was retrospective, relying on medical records and measurements.

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 surgically implanted spinal rod system, not an AI-assisted diagnostic tool for human readers.

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

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

7. The Type of Ground Truth Used

For the predicate device's clinical study, the ground truth for "safety and probable benefit" was based on:

• Outcomes Data: Cobb angle correction, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
• Expert Clinical Assessment (Implied): While not explicitly stated as "expert consensus," the evaluation of these parameters and overall patient outcomes would inherently involve clinical expertise.

For the non-clinical tests of the MAGEC 2 System, the "ground truth" was established by conformance to established ASTM and ISO standards for mechanical performance, wear, particulate analysis, and sterilization.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the same reason as 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 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 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 open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The Ellipse PRECICE Trauma Nail System is composed of the PRECICE Trauma 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 PRECICE Trauma 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.

The provided document is a 510(k) premarket notification for the "PRECICE Trauma Nail System". The document states that the device is substantially equivalent to a previously cleared device (K141447) and relies on the testing and data from that predicate device. Therefore, a direct study proving the device meets new acceptance criteria is not presented, as the submission is based on demonstrating equivalence.

Here's an analysis of the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results for this specific 510(k) submission (K142599). Instead, it states that "all testing that was performed on the predicate PRECICE Trauma Nail System is applicable" because there are "no changes to the design of the PRECICE Trauma Nail being made as a result of this submission."

However, the document lists the types of tests performed on the predicate device, which can be inferred as satisfying the acceptance criteria for those tests:

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

The document does not specify sample sizes for individual tests. It refers to "mechanical testing according to the methods outlined in the standard ASTM F1264-03." These standards typically define sample size requirements.

• Data Provenance: The data comes from tests performed on the predicate device (K141447). The document doesn't specify the country of origin of this data or if it was retrospective or prospective, but it's implied to be data collected during the development and clearance process of the predicate device.

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

This type of information (experts for ground truth) is typically relevant for studies involving subjective human assessment (e.g., image interpretation for AI algorithms). For physical medical devices undergoing mechanical, sterilization, or biocompatibility testing, ground truth is established by the specified test standards and methodologies themselves (e.g., ASTM, ISO standards), not by human expert consensus in the same way. Therefore, this information is not applicable in this context and is not provided in the document.

4. Adjudication Method for the Test Set

As explained above, for physical device testing against established standards, adjudication methods like 2+1 or 3+1 (common in clinical trials or diagnostic studies) are not applicable. The "ground truth" and "adjudication" are inherent in the test method's specifications and the objective measurements obtained.

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

No, an MRMC study was not done. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often an AI algorithm, by comparing human reader performance with and without its assistance. The PRECICE Trauma Nail System is an intramedullary fixation rod, a physical implant, and therefore, an MRMC study is not applicable to its evaluation.

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

No, a standalone algorithm performance study was not done. This is also specific to AI/software as a medical device. The PRECICE Trauma Nail System is a physical device, and therefore this type of study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the predicate device's evaluation (and by extension, for this submission's substantial equivalence claim) is based on:

• Compliance with recognized industry standards: ASTM F1264-03 for mechanical testing, ANSI/AAMI/ISO 11137-2 for sterilization, and ISO 10993-1 for biocompatibility.
• Objective measurements and criteria: As defined within these standards for various performance parameters (e.g., strength, sterility assurance level, material compatibility).

8. The Sample Size for the Training Set

Not Applicable. The device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.

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The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.

The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments 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 RLL System is a non-weight bearing device.

The provided text describes a 510(k) premarket notification for the Ellipse Residual Limb Lengthening System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance. The information provided heavily relies on non-clinical testing.

Therefore, many of the requested categories cannot be directly addressed from the given text, as they pertain to clinical performance studies.

Here's an analysis based on the information available:

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

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., success rate of limb lengthening, complication rates within a defined threshold). Instead, it focuses on demonstrating equivalence through mechanical and functional tests.

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 primarily refers to non-clinical mechanical and functional testing. For these tests, sample sizes are typically determined by the specific ISO/ASTM standards referenced, but are not explicitly stated in this summary. There is no mention of a clinical test set, country of origin, or whether it was retrospective/prospective.

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 is not applicable as no clinical test set requiring expert ground truth or assessment is described in this 510(k) summary. The testing described is non-clinical.

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

This is not applicable as no clinical test set requiring adjudication is 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 is not applicable. The device is an intramedullary limb lengthening system, not an AI or imaging diagnostic device.

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

This is not applicable. The device is a surgical implant system, not an algorithm.

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

For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements of the referenced ASTM/ISO standards and the device's design specifications. For example, the "ground truth" for sterilization is achieving an SAL of 10-6 as per ISO 11137-2. For mechanical tests, it's meeting the load and torque requirements defined by ASTM F1264-03.

8. The sample size for the training set

This is not applicable as the device is a mechanical implant system, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

Summary based on available information:

The provided text focuses on demonstrating the substantial equivalence of the Ellipse Residual Limb Lengthening System to a legally marketed predicate device (Ellipse PRECICE® Intramedullary Limb Lengthening System K141023) through a series of non-clinical tests. These tests cover mechanical properties, sterilization, functionality, and biocompatibility, aligning with relevant ASTM and ISO standards. The "acceptance criteria" are implicitly set by these standards and the equivalence to the predicate device. The document does not contain information about clinical performance studies, expert assessment, or AI-related evaluations.

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