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The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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 subject MAGEC Spinal Bracing and Distraction System has an identical design and principle of operation to the predicate design iterations cleared in the predicate Magec System (K201543, K161751, K140613). The subject system includes sterile single use MAGEC rods manufactured from Ti-6Al-4V, conforming to ASTM F136, along with various accessories including a sterile Rod Template and Manual Distractor, a non-sterile Wand Magnet Locator, and is compatible with a hand held External Remote Controller (ERC) 1 or 2. The MAGEC rod can be surgically implanted using appropriate NuVasive Reline 4.5-5.0 (Reline Small Stature or RSS) or Armada fixation components (i.e., pedicle screws, hooks and/or connectors). The titanium MAGEC 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 either distract or retract the rod. Periodic distraction of the rod is performed to lengthen 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.

The provided text describes a 510(k) premarket notification for the MAGEC Spinal Bracing and Distraction System, focusing on expanding its indications for use. It primarily demonstrates substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the typical sense of a diagnostic or AI device.

However, based on the information provided, we can infer "acceptance criteria" from the measured clinical outcomes that are presented to support the expanded indication. The device's performance is demonstrated through a retrospective registry study comparing clinical and radiographic data.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" with numerical thresholds as one might find for a new, novel device. Instead, the study aims to show that the performance of the MAGEC System in older skeletally immature patients (subject group) is comparable to its established performance in younger patients (predicate group). Therefore, the "acceptance criteria" are implicitly that the clinical outcomes in the subject group should not be worse than those in the predicate group, supporting substantial equivalence.

| Acceptance Criteria (Inferred from comparison) | Reported Device Performance (Subject Group 2: Age ≥10 years) | Reported Device Performance (Predicate Group 1: Age

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The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).

The subject Precice Max System has identical indications for use as the predicate Precice Intramedullary Limb Lengthening System (K220234), which is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, and bone transport of long bones in bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). The subject system is designed to achieve limb correction through gradual lengthening or compression and provide intramedullary fixation for fractures of long bones. The Precice Max System includes similar devices as within the predicate Precice Intramedullary Limb Lengthening System (K220234): nail, endcaps, locking screws, surgical instruments, and remains compatible with the external remote controllers (ERC) (ERC 1, cleared via K113219; ERC 2P, cleared via K131490; or ERC 3P, cleared via K170169; or ERC 4P, cleared via K202348). The Precice Max intramedullary 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 diameters. 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 Max nail is implanted using locking screws and reusable surgical instruments.

This is a 510(k) summary for the Precice Max System, an orthopedic device, not an AI/ML powered medical device. Therefore, many of the requested categories are not applicable. However, I will extract the information that is available within the provided document.

Here's the breakdown of the acceptance criteria and study information available from the 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic device, the "acceptance criteria" are typically defined by recognized ASTM standards for implantable devices, and "device performance" is demonstrated by meeting or exceeding these standards. The document states that testing was performed to demonstrate substantial equivalence to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" is a nonclinical performance verification testing program. The document explicitly states:

"Nonclinical performance verification testing was performed to demonstrate that the subject Precice Max System is substantially equivalent to the predicate device, Precice Intramedullary Limb Lengthening System (K220234)."

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

This information is not provided in the 510(k) summary. For nonclinical performance testing of medical devices, sample sizes are typically determined by statistical methods and regulatory guidance for biomechanical testing, but the specifics are generally not included in the public 510(k) summary. Data provenance for such tests is typically from internal lab testing conducted by the manufacturer or a contracted lab.

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

This is not applicable as this is not an AI/ML device relying on expert-established ground truth from a test set. The performance is assessed against established engineering standards (ASTM).

4. Adjudication method for the test set

This is not applicable. The performance is assessed against established engineering standards (ASTM) through physical testing.

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. This is an orthopedic implant, not an AI/ML diagnostic tool.

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

This is not applicable. This is an orthopedic implant.

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

The "ground truth" for this device's performance is based on established engineering standards (ASTM) for implantable devices, representing objective physical and mechanical properties.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device that requires a training set. The device's design and manufacturing rely on established engineering principles and materials science.

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

This is not applicable.

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The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage nail is compatible with an accessory External Remote Controller (ERC). The Precice Ankle Salvage nail, endcap, and locking screws are supplied sterile by gamma radiation. The Precice Ankle Salvage nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage nail can be utilized to maintain compression across the tibio-talo-calcaneal ioints post-operatively. The Precice Ankle Salvage nail can also be used to subsequentially correct a limb length discrepancy that may result after the tibio-talo-calcaneal fusion procedure. The subject device is manufactured from medical grade Titanium alloy (Ti-6Al-4V) per ASTM F136. The Precice Ankle Salvage nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

This document is a 510(k) Premarket Notification for the Precice Ankle Salvage System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of a device's performance against specific acceptance criteria in a human-in-the-loop or standalone AI context.

Therefore, most of the requested information regarding acceptance criteria, human reader improvement with AI assistance, sample size for test/training sets, expert qualifications, ground truth establishment, and adjudication methods cannot be extracted from the provided text because this document is a regulatory submission for a physical medical device (an intramedullary fixation rod system), not an AI/software as a medical device (SaMD).

The document describes non-clinical performance verification testing for the physical device's mechanical properties, not clinical performance for diagnostic or prognostic purposes typically associated with AI/SaMD.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

• Device Name: Precice Ankle Salvage System
• Regulatory Class: Class II
• Product Code: HSB (Intramedullary Fixation Rod), HWC (Smooth or threaded metallic bone fixation fastener)
• Intended Use/Indications for Use: For tibio-talo-calcaneal fusions in adults, for fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. May be used for subsequent limb lengthening once fusion is achieved.
• Predicate Devices: Precice Ankle Salvage System (K200430) and Precice Intramedullary Limb Lengthening System (K220234).
• Material: Titanium alloy (Ti-6Al-4V) per ASTM F136.

Information that CANNOT be extracted from this document, as it pertains to AI/SaMD studies:

• Acceptance Criteria Table and Reported Device Performance (as pertains to AI/SaMD): Not applicable. The document lists mechanical tests for the physical device, not AI-driven performance metrics.
• Sample sizes used for the test set and data provenance: Not applicable for an AI study. The document refers to non-clinical mechanical testing, not a clinical study with patients/data.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI diagnostic device is not relevant here.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not for this type of device.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Study for the Physical Device (as present in the document):

The document defines acceptance criteria for the mechanical performance of the physical implant and demonstrates its substantial equivalence to predicate devices through non-clinical performance verification testing.

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

Study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is the "Nonclinical performance verification testing" conducted by NuVasive Specialized Orthopedics, Inc.

• Type of Study: Non-clinical (benchtop) mechanical and material testing.
• Purpose: To demonstrate that the subject Precice Ankle Salvage System, with its new titanium material and minor design changes, is substantially equivalent in terms of mechanical performance to its predicate devices.
• Methodology: The device components were subjected to various mechanical tests (dynamic/static compression bending, torsion, tensile, axial pullout, insertion/ultimate torque) according to recognized ASTM standards (F1264, F543) and internal methods (Distraction and Retraction Force, Wear Debris Testing, Corrosion Assessment).
• Results/Conclusion: "The results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the primary predicate." This implies that the device's performance metrics in these tests were comparable to or better than the predicate device, thereby meeting the necessary performance benchmarks for regulatory clearance.

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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® System (inclusive of Precice, Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions or bone transport of long bones.

The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.

The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The fourth generation External Remote Controller ERC 4P is a portable hand-held system used to non-invasively distract or retract the Precice System Family implants. The ERC 4P device has a touch screen interface, ergonomic design, a single magnet, and implant detection features that provide feedback to the user on the status of the coupling of the implant with the ERC 4P. It can be operated either cordlessly through a rechargeable battery or with a power cord. When the ERC 4P magnet begins to rotate, it induces a magnetic field which rotates an internal magnet attached to a lead screw in the implanted nail/plate, which then either distracts or retracts accordingly. The ERC 4P has a touch screen interface, as well as a hard button for the user's modes of interaction.

The provided text is a 510(k) summary for the NuVasive Specialized Orthopedics, Inc. External Remote Controller ERC 4P device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study design, or performance metrics typically associated with studies proving a device meets specific performance criteria, especially in the context of AI-driven medical devices that involve image analysis or diagnostic support.

The document primarily focuses on regulatory approval, establishing substantial equivalence for an orthopedic device controller based on its engineering characteristics and safety standards (Electrical Safety, EMC, Magnet Safety, Usability, Labeling Readability). It details the type of device (a remote controller for limb lengthening/fixation implants), its function (non-invasively distract or retract implants), and general safety testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present in the document. The document lists "Usability Study" as a test but provides no details on its methodology, acceptance criteria, or results.
• Sample sizes used for the test set and data provenance: No such data is mentioned.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as this device does not involve image analysis or diagnostic ground truth establishment by medical experts in the way an AI diagnostic tool would.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Stand-alone performance: Not relevant in the context of how this device's performance is assessed.
• Type of ground truth used: Not applicable.
• Sample size for training set and how ground truth was established: Not applicable, as this device is not a machine learning/AI model.

In summary, the provided document is a regulatory submission for a medical device that does not involve artificial intelligence, image analysis, or complex diagnostic performance evaluation as per your request's focus. The "performance data" referred to in the document pertains to electrical safety, electromagnetic compatibility, and magnet safety, rather than diagnostic accuracy or human-AI interaction in a diagnostic context.

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The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage Nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage Nail is compatible with an external remote controller (ERC). The Precice Ankle Salvage Nail and endcap are supplied sterile by gamma radiation. The locking screws are offered either sterile or non-sterile. The Precice Ankle Salvage Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage Nail can be utilized to maintain compression across the tibio-talo-calcaneal joints post-operatively. The Precice Ankle Salvage Nail can also be used to correct a limb length discrepancy that may result after the TTC fusion procedure. The subject device is manufactured from medical grade Biodur 108 alloy per ASTM F2229. The Precice Ankle Salvage Nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested in your prompt.

The document is a 510(k) premarket notification summary from the FDA, which focuses on establishing "substantial equivalence" of a new medical device (Precice® Ankle Salvage System) to already legally marketed predicate devices.

Here's why the requested information is absent:

• No Acceptance Criteria or Performance Data: The document states that "Nonclinical performance verification testing was performed to demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicate devices." It lists types of testing performed (Dynamic Compression, Bending Strength, Axial Pullout Strength, Insertion Torque, Torque Resistance, Distraction and Retraction Force) and applicable ASTM standards. However, it does not provide any specific acceptance criteria (e.g., "must achieve X MPa bending strength") nor does it report the device's actual performance results against any such criteria. It only states that the "results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicates."
• No Clinical Study Details: The document mentions a "cadaver lab was performed to address creation of osteotomy around the nail," but this is a pre-clinical, non-human study. There is no mention of a human clinical study, MRMC study, or any details about test set size, data provenance, expert ground truth, adjudication methods, or training set details. This type of information is typically found in clinical study reports, which are not part of this 510(k) summary.
• Focus on Substantial Equivalence, Not De Novo Performance: The core purpose of a 510(k) submission is to argue that a new device is "substantially equivalent" to a predicate device. This means demonstrating that it's as safe and effective as a device already on the market, rather than proving its absolute performance against predefined metrics in a clinical setting like a PMA de novo submission often requires.

Therefore, I cannot populate the table or answer the specific questions about the study design, experts, ground truth, or sample sizes because that information is not present in the provided text.

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The Precice® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Bone Transport System includes the Precice® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The Precice ® Bone Transport nails, screws and end caps are supplied sterile by gamma radiation while the instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The Precice® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The Precice® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted noninvasively by the External Remote Controller (ERC). The Precice ® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

This document is a 510(k) summary for the Precice® Bone Transport System. It refers to a medical device that recently underwent design modifications and is seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove a device meets acceptance criteria.

Therefore, the information required to directly answer your request (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth specifics) is not available in this document.

Here's why and what information is present:

1. Acceptance Criteria and Reported Device Performance: This document does not list specific acceptance criteria (e.g., target sensitivity, specificity, or accuracy) for a new algorithm or a device relying on complex performance metrics. Instead, it demonstrates the Precice® Bone Transport System's performance in terms of mechanical testing against relevant ASTM standards.

   • Mechanical Performance Data (from the table provided):
     • Static Compression Bending Strength: Tested against ASTM F1264.
     • Dynamic Compression Bending Strength: Tested against ASTM F1264.
     • Torsion: Tested against ASTM F1264.
     • Torque Resistance: Tested against ASTM F543.
     • Axial Pullout: Tested against ASTM F543.
     • Retention Force Testing: N/A (Standard not specified)
     • Distraction Force: N/A (Standard not specified)
   • Reported Performance: The document states, "The results demonstrate that the subject Precice® Bone Transport System is substantially equivalent to the predicate." However, it does not provide numerical performance data for these tests. It simply confirms the equivalence.

2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a clinical study involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., by experts interpreting images) is not relevant to this mechanical device submission.

4. Adjudication method: Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical intramedullary fixation rod, not an AI or diagnostic tool that would involve human readers.

6. Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.

7. Type of ground truth used: Not applicable in the context of expert consensus or pathology. The "ground truth" for the mechanical testing would be defined by the specifications and tolerances within the cited ASTM standards.

8. Sample size for the training set: Not applicable. This refers to machine learning, which is not described here.

9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA submission focuses on showing that a modified physical device is as safe and effective as its predecessor through mechanical testing, rather than presenting a performance study for an AI or diagnostic software product.

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The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb andle of 30 dearees 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® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, Reline 4.5-5.0 (Reline Small Stature) or Armada® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC 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) 1 or 2 that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC 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 either distract or retract the 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® System include the MAGEC Manual Distractor, MAGEC Rod Template, 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 Rod prior to implantation. The MAGEC Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. 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 previously implanted in a patient.

The purpose of this premarket notification is to implement assembly process changes and a design change to the MAGEC Rod cleared in K171791 to address the Field Safety Notice and Product Recall issued on February 13, 2020 for the MAGEC X device (FDA Recall Number Z-1898-2020 and Recall Event ID 85495).

The provided text is a 510(k) summary for the NuVasive MAGEC® System, which is a spinal rod system designed for skeletally immature patients with severe progressive spinal deformities. The submission aims to demonstrate substantial equivalence to previously cleared MAGEC systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for device performance in terms of specific thresholds for outcomes (e.g., minimum distraction force, maximum bending, etc.) that the device needed to meet. Instead, it refers to performance testing against established ASTM standards and internal verification for distraction/retraction. The general "acceptance criteria" can be inferred as demonstrating substantial equivalence to the predicate devices through successful completion of the listed nonclinical tests.

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

The document only mentions "nonclinical testing" and lists standards for mechanical testing. It does not provide details on the sample size for these tests (e.g., number of rods tested for bending, torsion, etc.). The data provenance is also not specified beyond being "nonclinical testing." It does not involve human data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

This information is not applicable. The testing described is nonclinical mechanical testing, not clinical studies requiring expert review or ground truth establishment in a diagnostic context.

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

This information is not applicable as the testing is nonclinical mechanical testing and does not involve human assessment or adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on nonclinical testing for substantial equivalence of a medical device (spinal rod system), not on diagnostic performance or human reader improvement with AI assistance.

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

This question is not applicable. The MAGEC System is a physical medical device (spinal rod and external controller), not an algorithm or AI system. Its performance is related to mechanical properties and functional reliability, not algorithmic accuracy.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the nonclinical tests is established by the specifications and acceptance limits defined within the referenced ASTM standards (e.g., specific forces, deflections, cycles, or distraction distances). The device is expected to meet or exceed the performance of the predicate and comply with these mechanical standards.

8. The Sample Size for the Training Set

This information is not applicable. The MAGEC System is a physical device, not an AI/ML model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. The purpose of this submission is to introduce additional compatible locking screws to the system.

This FDA 510(k) premarket notification (K193016) is for the PRECICE® Bone Transport System. This device is an intramedullary fixation rod used for limb lengthening, fracture fixation, and bone transport.

The document describes performance data for the device, but it does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner of a clinical or AI-driven diagnostic study. Instead, it focuses on nonclinical performance verification testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context as this is an evaluation of a physical medical device, not a diagnostic algorithm or AI.

However, I can extract the relevant information regarding the performance data that was provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, the "acceptance criteria" presented here is based on demonstration of substantial equivalence to the predicate device through performance testing. The reported device performance is that the "results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate."

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

This section is not applicable as the evaluation is based on nonclinical engineering performance testing (e.g., mechanical tests on physical parts), not a dataset of patient cases.

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

This section is not applicable. Ground truth, in the context of this device, would be established by validated engineering methodologies and potentially comparison to the predicate device's established performance.

4. Adjudication method for the test set

This section is not applicable. Mechanical testing results are objective measurements, not subject to expert adjudication.

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

This section is not applicable as this is not an AI-driven diagnostic device.

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

This section is not applicable as this is not an AI-driven diagnostic device.

7. The type of ground truth used

The "ground truth" for this device's performance testing is established through industry standards (ASTM F1264, ASTM F543) and inherent performance characteristics of the predicate device. The testing aims to show that the new device's mechanical properties meet relevant standards and are comparable to those of the already cleared predicate device.

8. The sample size for the training set

This section is not applicable as this is not an AI-driven device requiring a training set.

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

This section is not applicable as this is not an AI-driven device.

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The Precice® Screws are provided sterile and intended to be used with the systems below:

The Precice® Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Stryde System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Bone Transport Systemis indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.

The Precice® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones for pediatrics and small stature adult patients.

The Precice Screws accompanying previously cleared Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181) are available in a variety of lengths, materials and thread styles. The screws are offered in lengths between 10-100mm and styles including pegs, partially threaded and fully threaded shaft designs.

The purpose of this submission is to introduce a sterile option of previously cleared screws as part of the Precice System (K172628) and additional predicates, Precice Stryde System (K180503), Precice Bone Transport (K182170), and Precice Plate System (K192181).

Here's an analysis of the provided text, focusing on the acceptance criteria and study information related to the Precice® Screws.

It's important to note that the provided document is a 510(k) summary for a medical device (Precice Screws) intended to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the regulatory process and claims of equivalence rather than a detailed clinical study demonstrating new performance attributes against specific acceptance criteria for a novel device. The "performance data" section is very brief and refers to validation studies for sterilization and packaging, not clinical or functional performance of the screws themselves in a patient.

Acceptance Criteria and Study for Precice® Screws (K193617)

Given the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily regulatory in nature (demonstrating substantial equivalence to a predicate device) rather than clinical performance metrics for a novel technology. The "study" mentioned refers to validation testing for the sterilization and packaging of the screws, not a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

• Equivalent design
• Equivalent labeling/intended use
• Equivalent material composition
• Equivalent function | The subject Precice® Screws were shown to be substantially equivalent to the predicate devices (Precice® System K172628, Precice® Stryde System K180503, Precice® Bone Transport K182170, and Precice® Plate System K192181) through comparison in these areas. |
  | Sterility:
• Product must be sterile | Gamma sterilization validation was performed. |
  | Sterile Packaging:
• Packaging maintains sterility
• Sterile barrier integrity over time | Sterile packaging validation and integrity of the sterile barrier over time validation were performed. |

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

• Test Set Sample Size: Not specified in the document. The "tests" here refer to validation studies (sterilization, packaging), not clinical trials with patient data.
• Data Provenance: Not applicable in the context of clinical/patient data. The studies are laboratory/engineering tests performed by the manufacturer.

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

• Number of Experts: Not applicable. These are validation studies, not studies relying on expert interpretation of clinical data to establish ground truth.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to validation studies, not studies where human interpretation of medical data requires adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study investigates the performance of human readers, sometimes with and without AI assistance, which is outside the scope of this 510(k) submission for a fixation screw.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a surgical screw, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the regulatory submission, the "ground truth" for substantial equivalence was established by comparing the characteristics of the subject device (Precice® Screws) against the characteristics of the legally marketed predicate devices. For the validation studies, the ground truth would be accepted engineering and scientific standards for sterility and packaging integrity.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission concerns a physical medical device (screws) and its manufacturing/sterilization processes, not an AI or algorithm that would require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Document's Research Focus:

The provided document, a 510(k) summary, is not a clinical study report evaluating the performance of a device or algorithm in a patient population. Instead, it is a regulatory document to demonstrate that the Precice® Screws, specifically a new sterile option for previously cleared screws, are substantially equivalent to existing cleared predicate devices. The "performance data" referenced relates to validation studies for manufacturing processes (sterilization and packaging), which are necessary to ensure the safety and efficacy of the product as a sterile medical device, rather than studies evaluating the clinical effectiveness of the screw design itself.

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