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MySpine is intended as a thoracic and lumbar posterior pedicle targeting 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 to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. 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 equipments. 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 is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: Drill based and K-wire based. MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a 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 equipments. 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 MC and Drill Pilot guides are intended for single use only.

MySpine S2-Alar/Alar-Iliac is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine S2-Alan/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the surgical equipment selected. MySpine guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides are the same of the predicate devices cleared within K200792, K173472 and K153273. Based on the predicate, different screw placement guide configurations are object of this submission, specifically: MySpine Low Profile Guides: for K-wire guidance with conventional screw trajectory; MySpine Drill Pilot Guides: guidance for pedicle path preparation with conventional screw trajectory; MySpine MC/S1 Guides: Drill Pilot and K-wire guidance with cortical bone path; MySpine S2-Alar/Alar Iliac Guides: Drill Pilot guidance with cortical bone path. The MySpine Pedicle Screw Placement Guides are for use in spinal levels T1-S2/S2AI and ilium. The MySpine Pedicle Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle screws based on the patient's anatomy. The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Pedicle Screw Placement Guides fitting the patient's vertebral anatomy. The MySpine Pedicle Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version. The purpose of this submission is to obtain clearance of the MySpine Pedicle Screw Placement Guides for use with any compatible 510(k) cleared pedicle screw system.

The provided text focuses on regulatory approval (510(k) submission) for MySpine Pedicle Screw Placement Guides Extension and does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or comparative effectiveness with AI assistance.

The document states:

• "The subject devices are the same of the predicate devices (K200792, K173472 and K153273); therefore: no additional testing was required to support this 510(k)."
• "No clinical studies were conducted for the predicate (K200792, K173472 and K153273) nor for the subject devices."

Therefore, I cannot provide the requested information from the given text. The text explicitly mentions that no additional testing or clinical studies were conducted for this 510(k) submission as the devices are considered the same as previously cleared predicate devices, with only a change in indication for use.

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MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

• Drill based
• K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

Use of the guides involves a 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 MC and Drill Pilot guides are intended for single use only.

The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.

The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.

The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.

The provided document is a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria or performance data for an AI-powered device. The MySpine system described is a patient-matched surgical guide system that uses pre-operative CT scans to create 3D models and fabricate patient-specific guides. It utilizes software for planning, but it is not an AI/ML-driven device as understood in the context of diagnostic or prognostic AI.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The document primarily focuses on the physical design, manufacturing process, materials, and intended use of the surgical guides, along with non-clinical performance tests relevant to mechanical and design validation, and a statement that no clinical studies were conducted for this particular submission.

To answer your request, if this were an AI or ML-enabled device, the information would typically include:

1. A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc., along with the target thresholds (acceptance criteria) and the actual performance achieved.
2. Sample size used for the test set and the data provenance: Number of cases/patients in the test set, and details like country of origin, whether it was retrospective or prospective data, etc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For example, 3 radiologists with 5+ years of experience each.
4. Adjudication method for the test set: How disagreements among experts establishing ground truth were resolved (e.g., 2+1 means 2 experts agree, if not, a 3rd expert adjudicates; 3+1 means 3 experts agree, if not, a 4th adjudicates).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Details on the study design and the effect size (e.g., human readers improved AUC by X with AI assistance).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The results of the algorithm's performance without human intervention.
7. The type of ground truth used: For instance, expert consensus, pathology reports, clinical outcomes data, follow-up imaging, etc.
8. The sample size for the training set: Number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but often less stringent or by different methods depending on the training methodology.

Since the provided document does not pertain to an AI/ML device, I am unable to provide the specific details requested. The "Performance Data" section (page 7) lists only non-clinical studies related to design validation, stability, post-operative evaluation (accuracy of the physical guide), and wear tests for the physical instruments. It explicitly states "no clinical studies were conducted."

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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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MySpine is intended as a thoracic and lumbar posterior pedicle targeting quide 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. Use of the quides 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 surqiçal 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.

The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans.

The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited (

The provided document describes the MySpine Pedicle Screw Placement Guides, a patient-specific surgical instrument. It details performance testing and establishes substantial equivalence to a predicate device, but it does not include a typical AI/ML medical device study with acceptance criteria, sample sizes, and expert validation for an algorithm's performance.

Instead, the performance testing focuses on traditional medical device validation, such as biocompatibility, dimensional accuracy, mechanical testing, and process reproducibility. The document mentions "software tools used to manufacture the MySpine Pedicle Screw Placement Guides were validated for their intended use," but this refers to the software used for design and fabrication, not an AI algorithm performing diagnostic or predictive tasks.

Therefore, the requested information elements related to AI/ML device studies cannot be extracted from this 510(k) summary.

However, I can extract information regarding the general performance testing and a design validation cadaver study.

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

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