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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 AEGIS and AEGIS II Spinal Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system, The AEGIS I and AEGIS II Spinal Systems are indicated for patients with deqenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, turnor, pseudoarthrosis, or revision of failed fusion attempts.

The AEGIS® Pedicle Screw System is comprised of pedicle screw with diameters from 4.5mm to 8.5mm with increments of 1mm and length ranging from 20mm to 55 mm with increments of 5mm, a sleeve of standard diameter of 14 mm, and a set screw of M10XP1.0 & rods with standard diameter of 6 mm. All the components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The mono axial pedicle screw is used as an adjunct to spinal fusion surgery, provides a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments (e.g. lumbar segment 4 and 5) and then a short rod is used to connect the screws. This construct prevents motion at the segments that are being fused.

The Corentec® AEGIS II® Spinal system consists of various Pedicle Screws (mono / poly) with standard and guided type designs, Rod and Rod Link with a set screw, the assembly of which is intended to provide temporary stabilization following surgery to fuse the spine. This system is designed on the basis of long standing spinal technology which is already in the market for more than few decades.

The provided text describes mechanical performance testing for the AEGIS & AEGIS II Spinal Systems. This is not a study involving AI, human readers, or image analysis, but rather physical stress tests on the device itself. Therefore, many of the requested categories are not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each mechanical test. The "data provenance" in this context refers to the manufacturing and testing of the physical device components. The tests were performed on the AEGIS and AEGIS II Spinal Systems themselves. The country of origin for the submitter is Korea. The tests are prospective in the sense that they are conducted on newly manufactured devices to ensure they meet standards.

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

Not applicable. This was mechanical testing of a medical device, not a human reader study or clinical evaluation requiring expert interpretation of data. The ground truth refers to the physical properties and performance of the device under stress, as measured by standard engineering tests.

4. Adjudication method for the test set

Not applicable. This was mechanical testing against established ASTM standards, not a diagnostic or interpretive study requiring adjudication of human readings.

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 was a mechanical performance study of a spinal implant system, not a study involving human readers or AI assistance.

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

Not applicable. This was mechanical testing of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used was the performance of the device under specific mechanical stress tests, compared against the performance of "legally marketed predicate devices" as defined by established ASTM (American Society for Testing and Materials) standards (F1717-04, 543-07, F1798-97).

8. The sample size for the training set

Not applicable. This was not a machine learning study with a training set.

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

Not applicable. There was no training set.

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The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).

When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

This document describes a medical device, the MonoPoly Pedicle Screw System, and its regulatory filing, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and performance studies. The "Performance Testing" section explicitly states: "The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices." This implies the testing was comparative in nature against existing devices, not against a predefined set of acceptance criteria for a new device.

Here's a breakdown of what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not present. The document does not define specific performance acceptance criteria (e.g., in terms of strength, fatigue life, or other biomechanical properties). It also does not report specific quantitative performance data for the device against such criteria. The "Performance Testing" section only states that the testing indicated substantial equivalence to predicate devices.

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

• Not present. The document does not describe a clinical "test set" for performance evaluation in the way you're asking. The testing mentioned is "pre-clinical," likely referring to mechanical or biomechanical bench testing. No sample sizes for any test sets are provided, nor is any information about data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth is generally relevant for diagnostic or AI-driven devices where a human expert's judgment is used to label data. This document describes a mechanical implant, not a diagnostic device.

4. Adjudication Method:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This type of study is used for diagnostic imaging devices to assess human reader performance with and without AI assistance. The MonoPoly Pedicle Screw System is a surgical implant.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. This is a mechanical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Not applicable. See point 3.

8. Sample Size for the Training Set:

• Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a physical medical device.

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

• Not applicable. See point 8.

Summary from the provided text:

The MonoPoly Pedicle Screw System is a Class III spinal implant comprising various screws, rods, and connectors made from titanium alloy. It is intended to aid in spinal segment immobilization and stabilization as an adjunct to fusion for various spinal conditions. The pre-clinical testing indicated substantial equivalence to four predicate devices: Cross Medical Synergy VLS System (K974749), U&I Optima Xia System (K031585), GSS Medical GS System (K053573), and Signus Medical OvalTwist System (K061577). The document does not provide details of specific performance criteria or a study demonstrating the device meets such criteria, as its 510(k) clearance path relies on equivalence to existing devices.

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