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The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

• · Patients who may require serial magnetic resonance imaging;
• · Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

• · Patients at risk for implant prominence following surgery;
• · Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

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

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

4. Adjudication method for the test set: 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: Not applicable. This device is a physical spinal implant, not an AI or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

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

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

• Biocompatibility testing: To ensure the materials are not harmful to the body.
• MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
• Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

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RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System.

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø3mm to Ø8mm. The RESPONSE™ Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® Navigation System hardware and software.

The provided text describes a 510(k) premarket notification for the OrthoPediatrics RESPONSE™ Navigation Instruments. It does not present acceptance criteria or detailed study results in the format requested by the user.

The document states that the device was evaluated through:

• A detailed dimensional analysis and comparison with predicate devices.
• Testing per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."

The specific parameters tested under ASTM F2554-18 are:

• Single point measurement accuracy
• Instrument axis rotation measurement accuracy
• Instrument angular position perpendicular to the system camera measurement accuracy
• Instrument angular position parallel to the system camera measurement accuracy
• Distance between points measurement accuracy

The conclusion states that "The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the RESPONSE™ Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: While the tests performed (ASTM F2554-18 parameters) are listed, the specific acceptance criteria for each and the actual measured performance values are not disclosed in this document.
2. Sample size used for the test set and the data provenance: No sample sizes or details on data provenance (e.g., country of origin, retrospective/prospective) are mentioned for the non-clinical testing. This type of device (surgical instruments) typically undergoes lab testing rather than human clinical trials for substantial equivalence for this specific type of 510(k). The "test set" here refers to the instruments themselves, not a dataset of patient images or outcomes.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this was non-clinical performance testing of physical instruments, not a study involving expert interpretation of medical images.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this is a navigation instrument, not an AI or imaging diagnostic device that would typically involve human readers.
6. If a standalone performance study was done: Yes, the described non-clinical testing of the instruments against a standard (ASTM F2554-18) can be considered a form of standalone performance evaluation for the device's functional characteristics. However, "standalone" in the context of AI often implies algorithm-only performance without human input, which isn't the primary focus here.
7. The type of ground truth used: The "ground truth" for this device's performance is established by the measurements and specifications defined in the ASTM F2554-18 standard for positional accuracy in computer-assisted surgical systems.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (surgical navigation instruments) and details non-clinical laboratory testing rather than clinical study data involving AI algorithms or human interpretation of medical images.

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The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems are intended for immobilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pediatic patients, the Response 4.5/5.0 and 5.5/6.0 Spine System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The Response 4.5/5.0 and 5.5/6.0 Spine Systems are intended to be used with autograff and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 4.5/5.0 Spine System and RESPONSE 5.5/6.0 Spine System (herein referred to as the RESPONSE Spine Systems) are pedicle screw spinal implant systems consisting of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors), and fasteners in a variety of sizes to accommodate differing anatomic requirements. All implant components are manufactured from titanium alloy (6Al-4V-ELI; ASTM F-136), commercially pure titanium (ASTM F67), and cobalt-chromiummolybdenum alloy (ASTM F-1537). All system components and instruments are provided nonsterile.

The longitudinal members (rods) are provided in straight and pre-bent configurations. The anchors include a variety of hooks and pedicle screws. The interconnection components include rod-to-rod and anchor-to-rod connectors. The fasteners include set screws for all the pedicle screws, hooks and connectors. The system is implanted using general (Class I, 510(k) exempt) and specific (Class II) surgical instruments.

This submission adds additional rods, pedicle screws, anchor-to-rod connectors, and Class II instruments to the RESPONSE Spine Systems.

The provided text is a 510(k) summary for the RESPONSE™ Spine System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through comparison of design, materials, and intended use, along with mechanical performance testing.

It does not contain information related to a study that establishes acceptance criteria for, or proves the device meets, performance characteristics typically measured for AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). This type of device is a physical implant (pedicle screw system), and its "performance" is assessed through mechanical strength and durability testing, not through analysis of diagnostic accuracy or reader improvement.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (in the context of diagnostic accuracy/AI performance).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone performance (algorithm only).
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

However, I can extract the information provided regarding the mechanical performance tests, which serve as the "study" proving the device's physical capabilities.

Study information related to the device's physical performance:

1. Acceptance Criteria and Reported Device Performance (as related to mechanical testing):

The document lists the types of mechanical performance testing conducted, implicitly indicating that meeting the standards of these tests would be the acceptance criteria for the physical device components. Specific numerical acceptance values or reported performance metrics (e.g., maximum force before failure) are not explicitly provided in this 510(k) summary, only that the tests were performed.

2. Sample size used for the test set and data provenance:
Not applicable as this is mechanical testing of physical implants, not data-driven testing. The "test set" would be the number of physical implants tested for mechanical properties. This specific number is not disclosed in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in this context refers to the physical properties of the materials and constructs, established by engineering and material science standards (ASTM, ISO).

4. Adjudication method for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. This study type is for AI/human reader performance, not for physical implant performance.

6. If a standalone performance was done:
Not applicable in the context of AI/ML performance. Standalone performance here relates to the inherent mechanical properties of the devices themselves, which were tested.

7. The type of ground truth used:
Engineering and material science standards (e.g., ASTM, ISO guidelines for mechanical testing and biocompatibility).

8. The sample size for the training set:
Not applicable. The "training set" concept is for AI/ML models, not for physical device manufacturing.

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

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The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• · Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• · Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
• · Spinal degenerative surgery, as an adjunct to spinal fusions;
• · The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.

The RESPONSE BandLoc Spinal Fixation implant consists of a titanium alloy tulip head clamp attached to a polyester band and includes a set screw for affixing the clamp to a rod used for spinal fusion. The polyester band is available in two configurations-single and double (DUO) band. Both band configurations include a tip portion with an internal titanium insert enclosed in the band to enable the user to more easily pass the tip through the spinal anatomy. The final implanted devices are identical. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium alloy can be utilized.

All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

This submission adds an additional implant configuration to the system, describes a modification to a system-specific (Class II) instrument, and adds MR conditions to the labeling.

The system is implanted using general (Class I, 510(k) exempt) and system-specific (Class II) instruments.

The provided text describes a 510(k) premarket notification for the OrthoPediatrics Response BandLoc Spinal Fixation device. It highlights the device's indications for use, comparison to a predicate device, and performance data from mechanical testing, electromagnetic compatibility, and biocompatibility. However, it does not include information about specific acceptance criteria or an analytical study comparing the device's performance against those criteria in a format applicable to AI/ML devices, or detailed clinical study information with human readers, sample sizes for test/training sets, or methods for establishing ground truth as requested in the prompt.

The information provided pertains to a traditional orthopedic implant, not an AI/ML device. Therefore, many of the requested fields are not applicable to the content of this document.

Here's an attempt to answer the questions based only on the provided text, while noting the limitations due to the nature of the device:

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

   Acceptance Criteria	Reported Device Performance
   Withstand anticipated loads during sublaminar passage	The BandLoc DUO assembly passed an internal tensile strength test. "The subject device met the pre-determined acceptance criteria for all tests."
   Mechanical performance of fusion construct	Mechanical testing data from predicate K161267 leveraged to support static and dynamic compression testing of a spine construct (ASTM F1717). No specific performance results for the current device are provided, but leverage implies equivalence.
   Corrosion susceptibility	Mechanical testing data from predicate K161267 leveraged to support corrosion susceptibility (ASTM F2129) of the tulip head. No specific performance results for the current device are provided, but leverage implies equivalence.
   BandLoc Tensioner modification	"The modified instrument met pre-determined acceptance criteria" following life cycle testing to simulate worst-case use.
   MR-Conditional Status	Determined to be MR-Conditional in accordance with ASTM F2052 (Magnetic Induction Displacement), ASTM F2213 (Magnetically Induced Torque), ASTM F2182 (RF Induced Heating), and ASTM F2119 (MR Image Artifacts). This implies meeting the requirements of these standards for "MR-Conditional" labeling.
   Biocompatibility	Supported by leveraging information from predicate K161267 per ISO 10993-1. Implies the device is biocompatible based on similar materials and manufacturing.

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

   • Mechanical Testing (tensile strength): The document states "an internal method." No sample size is specified.
   • Mechanical Testing (fusion construct, corrosion): Leveraged from predicate K161267. No sample sizes specified in this document for the predicate's tests.
   • Electromagnetic Compatibility: No specific "test set" sample size for patients/cases is applicable since these are device-specific engineering tests. The tests were performed on the device itself.
   • Biocompatibility: Leveraged from predicate K161267. This typically involves material testing, not patient data in the context described.
   • Provenance: "internal method" suggests in-house testing.

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)

   • Not applicable to this type of device and testing. The ground truth for mechanical, EMC, and biocompatibility tests is established by published test standards and engineering principles, not expert medical opinion on images or clinical data.

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

   • Not applicable to this type of device and 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

   • Not applicable. This device is an orthopedic implant, not an AI/ML medical device designed to assist human readers.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML algorithm. The performance tests (mechanical, EMC, biocompatibility) are standalone for the device itself against established standards.

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

   • Mechanical Testing: Engineering test standards (ASTM F1717, ASTM F2129), internal test methods, and pre-determined acceptance criteria based on mechanical properties and expected loads.
   • Electromagnetic Compatibility: Published ASTM standards (F2052, F2213, F2182, F2119) for determining MR-Conditional status.
   • Biocompatibility: ISO 10993-1, which provides guidelines for biological evaluation of medical devices.

8. The sample size for the training set

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

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

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

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