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The Life Spine Hinged Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Hinged Laminoplasty System is used to hold or butresses the allograft or autograft material in place to prevent the graft material from expulsion or impinging the spinal cord.

The Life Spine Hinged Laminoplasty System consists of various plates and screw configurations to address surgeon and patient needs. The plates have screw holes at the ends that allow attachment to bone. The center hole of the plate allows it to be affixed to allograft or autograft material. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Hinged Laminoplasty System components with components from any other system or manufacturer. The Life Spine Laminoplasty System components should never be reused under any circumstances.

The provided text is a 510(k) summary for the Life Spine Hinged Laminoplasty System. It is a submission to the FDA for market clearance of a medical device, specifically a spinal interlaminal fixation orthosis.

This document describes the device itself (its components, materials, and intended use) and its substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI/software device that measures or analyzes data, nor does it provide acceptance criteria or performance data for such a device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria, as the input document is about the physical Life Spine Hinged Laminoplasty System and not an AI/software device.

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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 CANOPY™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The CANOPY™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impinging the spinal cord.

The CANOPY™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. CANOPY™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Fixation plates may be used with bone graft material. Hinge plates may be used to stabilize a weakened or displaced lamina. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

CANOPY™ plates and screws are manufactured from titanium or titanium allov. as specified in ASTM F67, F136, F1295 and F1472. Optional graft chambers are manufactured from radiolucent polymer as specified in ASTM F2026 and contain tantalum or titanium alloy markers to permit radiographic visualization, per ASTM F67, F136, F560, F1295 or F1472.

The provided document is a 510(k) summary for a medical device called the CANOPY™ Laminoplasty Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data.

However, the document does not contain information related to an AI/ML device study. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, or details about test sets and training sets for an AI/ML model.
• Information about experts, ground truth adjudication, or multi-reader multi-case studies related to an AI/ML model.
• Any mention of standalone algorithm performance or human-in-the-loop performance with AI assistance.

Instead, the performance data cited refers to "Mechanical testing (static and dynamic compression, static compression bending and expulsion) was conducted in accordance with ASTM F543 and F2193 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004." This indicates physical testing of the implant's mechanical properties, not an AI/ML diagnostic or prognostic study.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies related to an AI/ML device based on the provided text. The document describes a physical medical implant device, not an AI/ML software device.

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The Escalate™ Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.

The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.

The Stryker Spine Escalate™ Laminoplasty System is a mechanical device intended to hold the lamina open following a laminoplasty procedure. The acceptance criteria and the study that proves the device meets those criteria are detailed below, as per the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For mechanical devices like the Escalate™ Laminoplasty System, "acceptance criteria" generally refer to established engineering standards or performance thresholds that the device must meet to demonstrate safety and effectiveness for its intended use. "Reported device performance" refers to the results of tests designed to measure how the device performs against these standards.

Study Proving Acceptance Criteria are Met:

The study proving the device meets the acceptance criteria was a series of performance tests conducted to demonstrate substantial equivalence to existing legally marketed predicate devices.

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

• Sample Size for Test Set: The provided 510(k) summary does not specify the exact sample sizes (e.g., number of implants tested, number of screws tested) for each biomechanical test. It only states that "performance testing was conducted."
• Data Provenance: This information is not explicitly stated in terms of country of origin. Given that Stryker Spine is in New Jersey, USA, and is submitting to the US FDA, it is highly probable that the testing was conducted in the USA or by a testing facility compliant with US regulatory standards. The data is retrospective in the sense that it describes tests performed on physical device prototypes, not data gathered from a clinical trial in patients.

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

This section is not applicable to this type of device and study. The "ground truth" for mechanical performance is established by the specifications of the ASTM standards and engineering principles, not by expert consensus in the way a medical image diagnosis would be. The "experts" involved would be biomechanical engineers and technicians conducting and analyzing the tests, but their specific number and detailed qualifications are not typically reported in this summary format.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical outcomes where there might be disagreement, such as in reading medical images. For biomechanical testing, the results are quantitative measurements against established standards, not subject to subjective adjudication.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices where human readers interpret medical data, often with or without AI assistance, to assess diagnostic performance. The Escalate™ Laminoplasty System is a surgical implant, and its evaluation focuses on mechanical integrity and equivalence, not diagnostic accuracy or human interpretation.

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

This question is not applicable to this device. A "standalone" performance evaluation typically refers to the performance of an AI algorithm independent of human input. The Escalate™ Laminoplasty System is a physical implant; it does not involve an algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by:

• Established engineering standards and specifications: Specifically, the ASTM standards (ASTM 1717-11a for compression loading and ASTM F543-07 for screw-related tests) provide the benchmarks for acceptable performance.
• Performance of predicate devices: The "ground truth" for substantial equivalence is that the subject device performs similarly to or better than predicate devices already on the market and deemed safe and effective.

8. The Sample Size for the Training Set

This question is not applicable. The Escalate™ Laminoplasty System is a mechanical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not by a machine learning training dataset.

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

This question is not applicable for the same reasons as #8. There is no training set for this mechanical device.

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The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS 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/Titanium Alloy and will be provided non-sterile and or sterile.

The provided documentation describes a medical device, the "Aesculap Implant Systems Laminoplasty Plating System," which underwent a 510(k) premarket notification. This submission relies on performance data from in vitro testing rather than clinical studies or AI/algorithm performance. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for AI, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Performance: The device's performance was measured against the standards set by ASTM F2193 (for static and dynamic bending) and ASTM F543 (for screw pull-out). The submission states that the testing results demonstrate the device is "safe and effective comparable to other predicate systems currently on the market," implying that it met or exceeded the performance of these predicates under the specified tests. Specific numerical values for the acceptance criteria or the device's performance are not provided in this summary.

Regarding AI-specific questions (not applicable to this device submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. This device relies on in vitro mechanical testing, not a data-driven algorithm with a "test set" of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro mechanical testing is based on engineering principles and measurements rather than expert human interpretation of medical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. No AI component.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component.
• 7. The type of ground truth used: For this device, the "ground truth" for demonstrating safety and effectiveness comes from the engineering principles and material science underlying the ASTM standards (F2193 and F543). The outcome measures are physical properties (e.g., bending strength, pull-out force) measured directly, rather than medical observations.
• 8. The sample size for the training set: Not applicable. No AI component.
• 9. How the ground truth for the training set was established: Not applicable. No AI component.

Summary of the Study and Device Approval:

The "study" in this context refers to the performance testing conducted according to recognized industry standards (ASTM F2193 and F543).

• Study Type: In vitro mechanical testing.
• Purpose: To demonstrate the mechanical safety and effectiveness of the AIS Laminoplasty Plating System.
• Methodology: The system underwent static bending, dynamic bending, and screw pull-out testing.
• Result: The testing reportedly demonstrated that the device is "safe and effective comparable to other predicate systems currently on the market." This comparison implies that the device performed equivalently to, or better than, legally marketed predicate devices that have established safety and effectiveness.
• Clinical Testing: No clinical testing was performed for this submission; the 510(k) relies solely on the in vitro performance data and substantial equivalence to predicates (AIS Laminoplasty Plating System (K090354) and Synthes AFS (K032534)) based on material, design, function, and intended use.

This 510(k) clearance (K103284) was granted based on the demonstration of substantial equivalence to predicate devices through in vitro performance testing, rather than through clinical trials or AI algorithm validation.

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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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