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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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