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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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