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The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended for immobilization and stabilization 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 dicogenic 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), turnor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100. Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths. All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. All components are supplied non-sterile. The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths: Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm. All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws. For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation. The subject drivers are cannulated with features to interface with the screw hexalobe.

The provided text is a 510(k) summary for the OrthoPediatrics RESPONSE 5.5/6.0 Cannulated Screw System, a medical device for spinal fixation. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing. It does not describe a study involving human readers or AI performance in diagnostic or clinical tasks.

Therefore, the requested information regarding AI performance, human reader studies, ground truth establishment for AI, and related metrics cannot be extracted from this document, as it is not relevant to the type of device review described.

Below is the information that can be extracted, primarily related to the mechanical performance testing of the device for its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted to support substantial equivalence. The acceptance criteria themselves are not explicitly detailed as numerical thresholds in this summary, but rather implied as meeting the standards set by the predicate device and relevant ASTM standards. The "reported device performance" is that the device "supports the differences between the subject and predicate devices" and "is substantially equivalent."

Information Not Applicable to this Device/Study:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, and the "tests" refer to laboratory-based mechanical and material performance evaluations, not diagnostic image analysis or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical testing is defined by engineering specifications and material properties, assessed in a lab, not by expert human interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for mechanical testing.
• 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. There is no AI component in this device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI component.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical tests, the ground truth is based on physical scientific principles, engineering standards (ASTM), and direct measurement of material and structural performance, not expert consensus or clinical pathology.
• The sample size for the training set: Not applicable. Pertains to AI model development.
• How the ground truth for the training set was established: Not applicable. Pertains to AI model development.

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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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