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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 MAGEC® 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 System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® 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 Manual Distractor used with the MAGEC System is made of Radel and contains a rare-earth magnet. 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 provided documents describe the MAGEC® System, a non-fusion growing rod system for pediatric spinal deformities. The information included focuses on the FDA 510(k) submission for this device, which aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which is typically a high-level overview. It often summarizes the conclusions of testing rather than providing detailed raw data or specific numerical acceptance limits for each test. For a full understanding of the acceptance criteria, one would need to review the complete testing protocols and reports submitted to the FDA, which are not included here.

Study Information

Based on the provided text, the following information can be extracted or inferred:

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

   • Sample Size: The document does not specify the sample sizes (number of devices or tests performed) for the mechanical (static and dynamic) or pyrogenicity tests. It only lists the types of tests.
   • Data Provenance: The studies were nonclinical (bench testing) performed by the manufacturer, NuVasive Specialized Orthopedics, Incorporated. The country of origin for the data is not explicitly stated but would presumably be the US where NuVasive is located. These are not clinical studies with human subjects or retrospective/prospective human data.

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

   • Not Applicable. This was a nonclinical, bench-testing study to evaluate mechanical and biological safety (pyrogenicity) properties, not a study involving human readers or expert evaluation of images/data for ground truth establishment.

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

   • Not Applicable. Adjudication methods are typically relevant for clinical studies where multiple experts assess cases and their agreement or disagreement needs to be resolved. This document describes nonclinical engineering and safety testing.

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 study was not done. This device is a surgical implant system, not an AI-powered diagnostic or assistive tool.

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

   • Not Applicable. This device is a physical medical device (implant and external controller), not an algorithm or AI system.

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

   • Engineering Standards and Safety Limits. The "ground truth" for the nonclinical tests were the specifications and criteria defined by the relevant ASTM and ANSI/AAMI standards (e.g., ASTM F1717-15 for spinal implant constructs, ANSI/AAMI ST72 for bacterial endotoxins). For "substantial equivalence," the performance of the device was compared directly to that of the predicate device, implying the predicate's performance served as a benchmark for acceptable "truth."

7. The sample size for the training set:

   • Not Applicable. This is not a machine learning or AI device, so there is no "training set."

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

   • Not Applicable. As there is no training set for an AI/ML algorithm.

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The NSO Supplemental Instrument Trays are intended to organize, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The following sterilization cycle is to be used:

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

The validated worst case loading configuration (non-stacked) for the Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:

| Tray | Model | Dimensions
(Inner Diameter x Length) | Number of
Lumens | Maximum Weight
(lbs.) |
|------------------------------|----------|-----------------------------------------|---------------------|--------------------------|
| Supplemental Instrument Tray | SIT1-000 | 0.146" x 10.75" | 1 | 10.0 |
| Supplemental Reamer Tray | SRT1-000 | 0.125" x 18.4" | 1 | 13.1 |
| Flexible Reamer Tray | SRT2-000 | 0.096" x 19.314" | 1 | 14.4 |

The NSO Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray, a Supplemental Reamer Tray, and a Flexible 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 Instruments within the trays are composed of Flexible Reamers, Quick Connect Adaptors, an Intraoperative X-Ray Ruler, a Direct AO Depth Gauge, a Diamond Point Awl, a Guide Wire Chuck, a Soft Tissue Protector - Paddle, a Soft Tissue Protector - Tube, a Teardrop Cannulated Driver, a Screw Gauge, and a Guide Wire Pusher. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth). The Supplemental Reamer and Flexible Reamer Tray have the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth). An insert tray is used with the Supplemental Reamer and Flexible Reamer Tray. The insert tray for the Supplemental Reamer Tray has the following dimensions: 497 mm (length) x 240 mm (width) x 52 mm (depth). The insert tray for the Flexible Reamer Tray has the following dimensions: 490 mm (length) x 240 mm (width) x 52 mm (depth). The 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 provided text describes information about the NSO Supplemental Instrument Trays and a new Flexible Reamer Tray, which is being evaluated for substantial equivalence to a predicate device. The information focuses on design, materials, and sterilization validation rather than on AI/ML device performance. Therefore, many of the requested points are not applicable.

Here's an analysis of the provided text against the requested criteria:

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

The document does not specify general "acceptance criteria" for the overall device in terms of diagnostic performance metrics like sensitivity, specificity, or AUC, as it's not an AI/ML diagnostic device. Instead, it refers to validation criteria for sterilization and cleaning processes, which are listed in the tables below. The document explicitly states that the acceptance criteria for the drying time validation were met.

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 refers to "testing" and "validation" for sterilization and cleaning. However, it does not specify a numerical sample size for these tests in terms of how many trays were tested or the number of runs. It mentions "100 sterilization cycles" for material compatibility. The document also does not specify the data provenance (e.g., country of origin, retrospective/prospective). Since this is a test for a physical medical device (instrument trays), the "test set" would refer to the physical trays and instruments subjected to the validation processes.

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. The device is a physical instrument tray, not an AI/ML diagnostic product, so there is no "ground truth" to be established by experts in the context of diagnostic interpretation. Ground truth for sterilization efficacy is typically established through biological indicators and physical/chemical indicators, not expert consensus.

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

This question is not applicable for a physical instrument tray. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess medical images/data and need to resolve discrepancies, which is not relevant here.

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

This question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices, which is not the case for these instrument trays.

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

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

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

For the sterilization validation, the "ground truth" would be established by objective measurements verifying sterility assurance levels (SAL of 10^-6), absence of moisture, and maintenance of weight/integrity after sterilization. For cleaning validation, the ground truth would be based on test results for hemoglobin, Micro BCA protein, and TOC meeting acceptance criteria. These are empirical/scientific ground truths rather than expert consensus on interpretation.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set. The "training" for such physical devices involves rigorous design, material selection, and engineering validation.

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

This question is not applicable. There is no AI/ML training set.

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