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The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.

The provided text describes the Spectrum Spine Laminoplasty Plating System and its performance data for a 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance in those terms (apart from passing certain ASTM standards), or details about a study that would address most of the requested information.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing according to established ASTM standards. It does not describe a clinical study or a study comparing the device's performance against specific, quantifiable acceptance criteria in a clinical context.

Therefore, for many of your requested points, the information is not available in the provided text.

Here is the information that can be extracted or deduced from the provided text, and where the information is not available, it is stated as such:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Reported Device Performance": The document states that the device "was tested" according to specific ASTM standards and that the data "lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices." This implicitly means the device met the requirements of these tests, but the specific numerical results or thresholds (acceptance criteria) for those tests are not detailed in this summary.

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

• Sample Size: Not specified. The testing described is mechanical (physical hardware testing), not clinical or involving human subjects/cases in the traditional sense of a "test set" for performance evaluation.
• Data Provenance: The "performance data" refers to mechanical testing.
  • Country of origin: Not specified, but likely performed in a certified lab in the USA, given the FDA submission.
  • Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical data collection.

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

• Not applicable. The "ground truth" for this device's performance evaluation is based on established engineering standards (ASTM F543-07 and ASTM F2193-02) and material specifications (ASTM F136), not expert consensus from clinical cases. There's no mention of experts establishing a ground truth in the context of device performance as one would for an AI/diagnostic device.

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical studies where expert reviewers independently assess cases and then reconcile discrepancies. The reported testing is mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not relevant for this type of mechanical implant device. This type of study is typically performed for diagnostic or AI-assisted interpretation devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

• Engineering Standards and Material Specifications: The ground truth for evaluating the device's safety and effectiveness for a 510(k) submission is based on adherence to established ASTM standards for mechanical properties (e.g., strength, durability) and material composition (titanium alloy as per ASTM F136), demonstrating substantial equivalence to previously marketed devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical surgical implant. There is no training set in the context of machine learning or AI.

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

• Not applicable. See point 8.

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The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

The Pioneer Release Laminoplasty Plating System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document describes the acceptance criteria and the study that proves the Pioneer Release Laminoplasty Plating System meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated in the provided document. The document mentions "standard testing" per ASTM F2193 and ASTM F543, implying that the number of samples would conform to the requirements of these standards.
• Data Provenance: The study appears to be a laboratory-based performance test conducted by the manufacturer, Pioneer Surgical Technology. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical setting. The tests were performed on the device components themselves.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Not applicable. This device is a medical implant, and its performance was evaluated through mechanical testing, not by expert review of imaging or clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation was based on mechanical test results against established ASTM standards, not on expert adjudication of clinical or imaging data.

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

Not performed. This study focuses on the mechanical performance of a spinal implant system. MRMC studies are typically used for diagnostic or screening devices where human readers interpret data, often with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this study was established by recognized ASTM standards (F2193 and F543) for the mechanical performance of spinal implants. The device's ability to maintain its structural integrity and mechanical properties under specified loads, as defined by these standards, constituted the success criteria.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable, as no training set was used.

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The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium Alloy and will be provided non-sterile and or sterile.

The provided text describes a 510(k) summary for the Aesculap Implant Systems Laminoplasty Plating System. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text.

Here is an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

The document states: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." and "Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market."

However, specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) and the corresponding quantitative performance results of the Aesculap device are not provided. The assessment relies on a qualitative statement of "similar in performance" and "comparable to other predicate systems."

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

This information is not provided in the document. The text only mentions "biomechanical testing" and "testing results" without details on sample sizes or data provenance.

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):

This information is not applicable as the document describes biomechanical testing of a medical device, not a diagnostic or screening device that would require expert-established ground truth.

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

This information is not applicable for biomechanical testing.

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 information is not applicable as this is a physical implant device, not an AI-assisted diagnostic or imaging device.

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

This information is not applicable as this is a physical implant device, not an algorithm.

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

The "ground truth" for biomechanical testing would typically be engineering standards or established physical properties. The document states that testing was done per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" and "Spinal System 510(k)s." This implies the use of established engineering and regulatory testing standards to define acceptance.

8. The sample size for the training set:

This information is not applicable as this is a physical implant device, not an AI/ML system that requires a training set.

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

This information is not applicable as this is a physical implant device, not an AI/ML system.

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