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MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.

MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws.

Use of the guides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw placement guides are intended for single use only.

MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine Pedicle Screw Placement Guides (K132788). MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided K-wire placement. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. Then, the K-wire is guided through the patient's anatomically matched MySpine LP Guides in order to provide positioning according to the surgeon's preoperative planning.

For the standard guides introduced and cleared by FDA in K132788, the holes guide the instruments used to open and prepare the pedicle to the planned entry point. After pedicle preparation, the pedicle screws will be inserted through the guiding hole into the pedicle and the vertebrae respectively. For the LP guides introduced with this 510(k), the guiding holes allow placement of the K-wire. Then, the MySpine guide is removed and the wires are used to insert cannulated implants. As an intermediate step, the surgeon can also use the cannulated awl and/or tap to better prepare the entry point in order to simplify the screw tightening.

The components of the MySpine Pedicle Screw Placement Guides - LP include a Drill Guide (PA12 Medical Grade) and Vertebral Bone Models (PA12 Medical Grade). The MySpine Pedicle Screw Placement Guides – LP are single use, external communicating devices with limited (

The provided text describes a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - LP. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information (such as specific acceptance criteria and detailed study designs for a new device's performance) is not explicitly present.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence, meaning the device performs as safely and effectively as the predicate, rather than providing numerical acceptance criteria for a new device's performance. The "Performance Testing" section lists types of tests conducted (e.g., mechanical testing, cadaver testing), but not specific acceptance criteria or quantitative performance results.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated for each test listed.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The mention of "cadaver testing" implies prospective testing on cadavers, but further details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The document refers to "surgical planning software used pre-operatively to plan the surgical placement... on the basis of patient radiological images." However, it does not detail how the ground truth for any performance testing (e.g., accuracy of screw placement) was established or by whom.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not provided.

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/not reported. The device described is a physical pedicle screw placement guide, not an AI-driven diagnostic or interpretative system that would involve human "readers" or "AI assistance" in the context of diagnostic performance.

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

This is not applicable/not reported. The device is a surgical guide that assists a surgeon in placing K-wires; it's not a standalone algorithm. Its function inherently involves human intervention.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not explicitly specified in detail. For "cadaver testing," the ground truth would likely involve anatomical dissection or high-resolution imaging post-placement to assess accuracy, but the method is not described.

8. The Sample Size for the Training Set:

This information is not provided. The device uses "surgical planning software ... based on the patient's spinal CT scans" to create patient-specific guides. This implies patient-specific data for each case, but no "training set" in the machine learning sense is described for the device's development or validation.

9. How the Ground Truth for the Training Set was Established:

This information is not provided. As mentioned above, a "training set" for an algorithm in the typical sense is not described.

Summary of available information regarding performance testing for supporting substantial equivalence (not detailed acceptance criteria for a novel device):

• Performance Testing Leveraged or Conducted:
  • Sterilization validation (in accordance with ANSI/AAMI/ISO 11137-1 and -2)
  • Packaging validation (in accordance with ANSI/AAMI/ISO 11607)
  • Biocompatibility (in accordance with ISO 10993-1)
  • Mechanical testing
  • Cadaver testing

The document asserts that "The safety and effectiveness of the MySpine Screw Placement Guides - LP are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification," but does not elaborate on the specific results or acceptance criteria for these tests. The primary objective of the 510(k) is to demonstrate that the modified device (MySpine Pedicle Screw Placement Guides - LP) is substantially equivalent to its predicate (MySpine Pedicle Screw Placement Guides, K132788), implying that it meets the same safety and performance standards.

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