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The Pallas M Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudarthrosis).

The Pallas M Spinal System consists of rods, screws, revision rod system, lilac rod system, MIS pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

The provided 510(k) submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance testing. Instead, this submission relies on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (2-9) related to a performance study will be marked as "Not Applicable" or "Not Provided" because such a study was not performed for this specific submission as stated in the document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. No performance testing with a specific test set was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable / Not Provided. No performance testing with expert-established ground truth was conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No performance testing requiring adjudication was conducted for this 510(k) submission.

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

• Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

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

• Not Applicable / Not Provided. This device is a pedicle screw spinal system, not an algorithm. No standalone performance evaluation was done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided. No performance testing requiring ground truth was conducted for this 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. This submission is for a medical device (spinal implant), not an AI algorithm.

Summary of the Study (or lack thereof) to Prove Acceptance:

The Pallas M Spinal System obtained 510(k) clearance by demonstrating substantial equivalence to an existing legally marketed device, the "Pallas M Spinal System (Korea Bone Bank Co., Ltd.; K102574)".

The key points from the submission are:

• No additional testing was performed for this 510(k) submission. The device's safety and effectiveness were concluded by comparing its design, materials, indications for use, intended use, packaging, labeling, and performance to the predicate device.
• The difference between the subject device and the predicate device is limited to the addition of curved rods and new surgical instruments. The submission implies these minor differences do not alter the fundamental safety and effectiveness profile such that new performance testing would be required.
• The FDA's clearance is based on the determination that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the legally marketed device to which it is compared. This is a common pathway for medical device clearances where new performance data specific to the device being submitted is not always required if equivalence to an already cleared device can be sufficiently demonstrated.

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The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Pallas M Spinal System consists of rods, screws, revision rod system, Miss pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

Based on the provided 510(k) summary, the device is a spinal fixation system, and its performance is evaluated through bench testing, rather than clinical studies involving human or AI performance. Therefore, many of the requested categories (like sample size of a test set, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this type of submission.

The acceptance criteria are based on established standards for spinal implants.

Acceptance Criteria and Reported Device Performance

• Static axial compression bending test
• Dynamic axial compression bending test
• Static torsion test (of worst-case Pallas M Spinal System structure) |
  | Conformity to ASTM F136 (Material specification for Ti-6Al-4V ELI) | Fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. |
  | Conformity to relevant ISO Standards (for materials) | Devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards. |

Explanation: The device aims to meet the mechanical performance and material specifications defined by these ASTM and ISO standards for spinal implant systems. The reported performance indicates that the required bench tests were conducted and the materials conform to the specified standards, implying the device met the criteria outlined in those standards.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. For bench testing, "worst-case" configurations of the spinal system were tested. The mechanical testing report (Appendix 1) would typically contain detailed specimen numbers, but this is not included in the summary.
   • Data Provenance: Bench testing, performed by the manufacturer, Korea Bone Bank Co., Ltd. (South Korea).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This device underwent bench testing against engineering standards, not clinical ground truth established by medical experts for diagnostic or clinical performance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical bench testing. The results are typically interpreted against the pass/fail criteria defined in the ASTM standard.

4. 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:

   • N/A. This is a hardware spinal implant, not an AI or imaging device that would involve human readers or AI assistance.

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

   • N/A. This is a hardware spinal implant, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Engineering Standards: The ground truth for performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F1717-04 for mechanical performance, ASTM F136 for material composition and biocompatibility).

7. The sample size for the training set:

   • N/A. There isn't a "training set" in the context of mechanical bench testing for a physical implant. The design process and selection of materials are based on general engineering principles and material science.

8. How the ground truth for the training set was established:

   • N/A. See point 7.

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The EOS Spinal System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the EOS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The EOS Spinal System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.

The EOS Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EOS Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EOS Spinal System.

The provided text describes a 510(k) premarket notification for the EOS Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

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

This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way a clinical study report would. It states that "Performance data per ASTM F1717 were submitted to characterize the subject EOS Spinal System components." However, the actual performance values and the acceptance criteria they were measured against are not provided. The focus is on demonstrating equivalence to predicate devices.

2. Sample sized 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 submission for a spinal system, not an AI/software device that processes data for diagnosis or prognosis. The "test set" here refers to physical components tested against engineering standards (ASTM F1717), not a dataset of patient information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth as typically understood in AI/software validation is not relevant for this type of device. The "ground truth" for the performance testing would be the ASTM F1717 standard itself, and the testing would be conducted by engineers or testing laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human readers or expert consensus on medical images or patient data.

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:

Not applicable. This document describes a physical medical device (spinal implant system), not an AI-assisted diagnostic tool or software.

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

Not applicable. This is not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for the device's performance is adherence to mechanical and material standards (ASTM F1717) for medical implants.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/machine learning model.

9. How the ground truth for the training set was established:

Not applicable. This is a physical device, not an AI/machine learning model.

Summary of available information related to performance:

The document states that the EOS Spinal System's performance data was submitted per ASTM F1717. This standard is "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This implies that the device underwent mechanical testing to characterize its stability, strength, and other mechanical properties under simulated surgical conditions.

The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than showing that the device meets absolute acceptance criteria through clinical trials. The comparison to predicate devices (4CIS® Vane Spine System (Solco Biomedical Co., Ltd .; K060702) and GSS Pedicle Screw System (GS Medical Co., Ltd .; K053573)) is based on "design, materials, indications and intended use, packaging, labeling, and performance." The implicit "acceptance criteria" here is that the performance of the EOS Spinal System is comparable to, and not worse than, that of the predicate devices under the standards like ASTM F1717.

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