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The Eagle Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.

The Eagle Anterior Cervical Plate System consists of an assortment of plates and screws. The Eagle Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Eagle Anterior Cervical Plate System.

It's important to note that the provided documents (sections {0} through {4}) are a 510(k) Summary and an FDA clearance letter for a medical device (Spinal Intervertebral Body Fixation Orthosis). Such documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with explicit performance criteria, sample sizes, and expert review methodologies as would be found in a clinical trial report for an AI/software as a medical device (SaMD).

Therefore, much of the requested information (especially regarding AI-specific criteria, ground truth, expert adjudication, MRMC studies, and detailed performance metrics) is not present in these documents because they describe a physical implant, not an AI-driven diagnostic device.

Revised Analysis Based on Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Performance data were submitted to characterize the Eagle Anterior Cervical Plate System." However, the specific details of these performance data (e.g., in vitro mechanical testing results, specific values for strength, fatigue, etc.) are not included in this 510(k) summary. The summary only implies that such data were submitted and found acceptable by the FDA to demonstrate substantial equivalence to the predicate device. For mechanical devices like this, the "study" would primarily involve bench testing (e.g., static and dynamic load testing, pull-out strength, torque tests) and material characterization, rather than clinical trials with human subjects in the typical sense of showing diagnostic accuracy.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) summary for a physical implant. The "test set" would primarily refer to the physical specimens (e.g., number of plates or screws tested) for mechanical characterization. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of this 510(k). The data would be from laboratory bench testing.

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

• This is not applicable. For a physical implant, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM F-136 for titanium alloy), and mechanical testing results compared against predefined thresholds or predicate device performance, not by expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human interpretation of data (e.g., medical images). For mechanical testing, the "adjudication" is typically the comparison of quantitative test results against acceptance criteria.

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

• No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially AI in medical imaging) to assess how human readers perform with and without AI assistance. This device is a physical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone study was not done. This concept applies to AI algorithms. The Eagle Anterior Cervical Plate System is a physical medical implant.

7. Type of Ground Truth Used

• Engineering specifications, material standards, and mechanical test results. For a physical implant, the "ground truth" relates to its material properties, structural integrity, and functional performance under simulated physiological stresses, all measured against established engineering benchmarks and comparisons to the predicate device's known performance.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant. The concept of a "training set" is relevant for machine learning algorithms.

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

• Not applicable. As above, this concept does not apply to a physical implant.

In summary: The provided 510(k) documentation focuses on demonstrating the substantial equivalence of a physical medical implant (Eagle Anterior Cervical Plate System) to a previously cleared predicate device. It highlights the device's material, intended use, and general statement about performance data, but does not contain the detailed clinical study information relevant to AI/SaMD, such as specific acceptance criteria for diagnostic accuracy, expert review methodologies, or training/test set details.

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The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the DePuy AcroMed VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, and Profile).

Additional size components in various sizes and footprints. The DePuy AcroMed VBR System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device, the DePuy AcroMed VBR System, and its indications for use in the context of a 510(k) premarket notification. It does NOT contain information about acceptance criteria, device performance metrics, or any studies demonstrating that the device meets specific performance criteria.

The document states: "Performance data were submitted to characterize the additional components of the DePuy AcroMed VBR System." However, the actual performance data, acceptance criteria, or details of the study itself are not included in the provided text.

Therefore, according to the input, I cannot furnish the requested information.

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The DePuy AcroMed VBR System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The DePuy AcroMed VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The DePuy AcroMed VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The DePuy AcroMed VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR System include DePuy AcroMed titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch, and Profile).

The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.

The provided text describes specific details about a medical device known as the DePuy AcroMed VBR System, focusing on its acceptance criteria and the study used to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions that "worst case testing for the system has been provided in Test Report ACRO-0400-01" and that a "Design Risk Analysis was used to assess risk for the additional sizes... performed in accordance with DePuy AcroMed Design Control and Quality procedures using static testing."

• Sample Size for Test Set: Not explicitly stated in terms of number of devices or scenarios. The phrase "worst case testing" suggests a selection of samples representing the most challenging conditions.
• Data Provenance: The testing was "performed in accordance with DePuy AcroMed Design Control and Quality procedures," indicating an internal, manufacturer-driven study. The provided text doesn't specify the country of origin of the data or if it was retrospective or prospective, though internal product testing is typically prospective.

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

Not applicable. This study refers to mechanical testing of a spinal implant, not a diagnostic or algorithmic device that requires expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This is a physical device testing, not a study involving human interpretation or subjective assessment that would require an adjudication method.

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

No. This is a submission for a physical medical device (spinal implant), not an AI/software device that would typically involve an MRMC study.

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

Not applicable. This is a physical device submission.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance with acceptance criteria was mechanical performance metrics obtained through static testing. The performance of the new sizes was compared against the "previously cleared" predicate devices K990148 and K001340.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device and does not involve machine learning algorithms with a "training set."

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

Not applicable. As above, this is a physical device.

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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 -- S1 vertebral joint, having fusions with autogenous bone graft. with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws are designed to accept a 5.5mm rod and are available in various sizes.

The Moss Miami Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the Moss Miami Spinal System Polyaxial Screws, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.

Instead, the submission relies on the established safety and effectiveness of predicate devices. The FDA determines "substantial equivalence" based on factors like:

• Intended Use: The Moss Miami Spinal System Polyaxial Screws share similar intended uses with the predicate devices.
• Technological Characteristics: The device is described as Polyaxial Screws designed to accept a 5.5mm rod, which is compared to existing Moss Miami Spinal System components.
• Performance Data: While not explicitly detailed, 510(k) submissions typically include non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate device and meets established engineering standards. However, these specific test results are not part of this summary document.

In summary, this document is a regulatory approval notice based on substantial equivalence, not a study report demonstrating acceptance criteria and device performance as would be found in a clinical trial.

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The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Not Found

The provided text describes the regulatory clearance for the "Surgical Titanium Mesh™ System" as a medical device, focusing on its intended use and general performance data (biomechanical testing). It does NOT contain information about acceptance criteria for device performance, a study to prove it meets those criteria, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be extracted based on the provided document:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. This document pertains to a 510(k) submission for a medical device and typically such submissions detail testing protocols and results, but this specific excerpt doesn't provide those details.

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 as this is a physical medical device (implant) and not related to AI or diagnostic image analysis where expert-established ground truth for a test set would be relevant.

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

• Not applicable for a physical medical device.

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 is a physical medical device, not an AI diagnostic tool.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. Performance for this device would be based on engineering and biomechanical standards, not a clinical "ground truth" as typically defined for diagnostic AI. The "performance data" mentioned is biomechanical testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• spondylolisthesis
• spinal stenosis
• fracture/dislocation
• atlanto/axial fracture with instability
• occipitocervical dislocation
• revision of previous cervical spine surgery
• tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

The Summit OCT Spinal System can also be linked to the ISOLA, TiMX. MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.

The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

Manufactured from ASTM F-136 implant grade titanium alloy.

The provided text is a 510(k) summary for a medical device (Summit OCT Spinal System Minipolyaxial Screws) and contains regulatory information, indications for use, and a description of the device. However, it does not contain any information about acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws."

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need a document that includes:

• Specific acceptance criteria (e.g., tensile strength, fatigue life, torsional stability thresholds).
• Details of mechanical or other performance studies.
• Results of those studies demonstrating compliance with the acceptance criteria.
• Information on human reader studies or ground truth establishment if this were an AI/image-based device, which it is not.

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The Devex Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Devex Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Not Found

The provided text describes the Devex Mesh™ System, a spinal intervertebral body fixation orthosis device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for an AI/software device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, primarily through materials and intended use.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

Acceptance Criteria and Device Performance Study (Devex Mesh™ System)

The provided document (K023835) is a 510(k) summary for the Devex Mesh™ System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting detailed acceptance criteria and a novel clinical study with quantitative performance metrics for a software or AI-driven device.

Key Findings from the Document:

• Device Type: Spinal intervertebral body fixation orthosis device (hardware, not AI/software).
• Purpose: To replace diseased vertebral bodies, treat fractures, achieve anterior decompression, and restore vertebral height in the thoracolumbar spine (T1-L5).
• Materials: Titanium alloy (Ti-6Al-4V).
• Predicate Devices: Surgical Titanium Mesh System (K003043, K020522) and Stackable Cage System (K990148, K001340).

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific quantitative acceptance criteria or detailed reported device performance values presented in a table format as would be expected for an AI/software device.

The document states:

• Performance Data: "Biomechanical testing, including static axial compression and dynamic axial compression, were conducted."

This statement confirms that testing was done, but does not provide:

• Specific numerical acceptance thresholds for static or dynamic compression.
• The actual results (e.g., maximum load, fatigue cycles) from these tests.
• A comparison of these results against the predicate device's performance or predefined acceptance criteria.

For a hardware device like this, acceptance criteria would typically involve engineering specifications related to:

• Static compression strength (e.g., ability to withstand a certain load without permanent deformation).
• Dynamic/fatigue strength (e.g., ability to withstand a certain number of loading cycles without failure).
• Corrosion resistance.
• Biocompatibility.
• Sterility.

However, these specific details are not present in the 510(k) summary. The submission likely references internal test reports that contain these data, but they are not included in this summary document.

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

Not Applicable (N/A) / Not provided.

For a biomechanical hardware test, the "sample size" refers to the number of devices or constructs tested. The provided text only states that "biomechanical testing... were conducted" but does not specify the number of samples (devices) used for static or dynamic axial compression tests. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of in-vitro biomechanical testing.

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

Not Applicable (N/A).

For biomechanical testing of a spinal implant, "ground truth" is established by physical measurement standards and engineering principles, not by human experts adjudicating images or clinical outcomes. The "experts" would be the engineers and technicians performing the tests according to established ASTM or ISO standards. Their qualifications would be in mechanical engineering, materials science, or related fields, with experience in orthopaedic implant testing. This information is not provided.

4. Adjudication Method for the Test Set

Not Applicable (N/A).

Adjudication methods (e.g., 2+1) are relevant for clinical studies or studies involving human interpretation (like radiologists reviewing images). For biomechanical testing, the "ground truth" is derived from physical measurements (e.g., load cells, displacement sensors) and engineering calculations based on the test setup and observed device behavior, not through expert consensus on qualitative data.

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

No, an MRMC study was not done.

MRMC studies are typically performed for diagnostic imaging devices or AI algorithms that assist human readers. This device is a surgical implant; therefore, an MRMC study is not relevant to its performance assessment as described in this 510(k) summary.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable (N/A).

This question is relevant for AI/software devices. The Devex Mesh™ System is a physical surgical implant, so there is no "algorithm only" performance to be evaluated. The biomechanical tests can be considered "standalone" in the sense that they evaluate the physical device properties without human intervention during the test itself, but this is distinct from the context of AI performance.

7. The Type of Ground Truth Used

For biomechanical testing, the "ground truth" is based on:

• Physical Measurement Standards: Force-displacement curves, ultimate load, and cycles to failure are measured directly using calibrated equipment according to recognized industry standards (e.g., ASTM F451 for static compression of metallic bone plates, or specific standards for vertebral body replacement devices).
• Engineering Principles: The interpretation of these measurements against defined mechanical properties of the material and design.
• Comparison to Predicate: The performance is typically compared to that of the predicate device, demonstrating that the new device is "substantially equivalent" in its mechanical characteristics.

8. The Sample Size for the Training Set

Not Applicable (N/A).

The concept of a "training set" refers to data used to train a machine learning model. This is a physical medical device, not an AI/software algorithm. Therefore, there is no training set in this context.

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

Not Applicable (N/A).

As there is no training set for an AI/software model, this question does not apply to the Devex Mesh™ System.

In summary, the provided 510(k) document (K023835) for the Devex Mesh™ System is for a physical medical device (vertebral body replacement) and focuses on demonstrating substantial equivalence through materials and biomechanical testing. It does not contain the detailed quantitative acceptance criteria or a specific study in the format typically associated with AI/software device submissions. The "performance data" section only states that biomechanical testing was conducted, without providing the specific results or acceptance values.

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The MONARCH Spine System is a pedicle screw system 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 MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Addition of 5.5mm diameter rod, screws, hooks and various connectors to the MONARCH Spine System. The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the MONARCH Spine System, an addition of 5.5mm diameter rod, screws, hooks, and various connectors. It is a medical device submission, and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical study with specific performance metrics against an AI algorithm.

Regarding your numbered requests, based only on the provided text, the following information can be extracted:

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

   Acceptance Criteria (Implied)	Reported Device Performance
   Safety and Effectiveness substantially equivalent to predicate devices	Performance data were submitted to characterize the MONARCH Spine System. (Specific results not detailed in the provided text.)
   Manufactured from ASTM F-136 implant grade titanium alloy	Manufactured from ASTM F-136 implant grade titanium alloy.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document states "Performance data were submitted to characterize the MONARCH Spine System." However, it does not provide details on the sample size used for the test set, the provenance of the data (e.g., country of origin), or whether the data was retrospective or prospective. This information would typically be found in the detailed performance data report, which is not included in this summary.

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):
   As this is a mechanical medical device (spinal implant), the concept of "ground truth" established by human experts in the context of diagnostic interpretation (like radiologists) is not applicable here. The "performance data" would likely refer to mechanical testing, biocompatibility testing, and potentially animal or clinical performance data if submitted, but not expert consensus on images. The document does not mention experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable for this type of device and performance data. The document does not mention any adjudication method.

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 device is a spinal implant, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a spinal implant, not an algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For a spinal implant, "ground truth" would generally refer to established engineering standards for mechanical strength, fatigue, biocompatibility, and potentially clinical outcomes if a clinical study was performed. The document vaguely states "Performance data were submitted to characterize the MONARCH Spine System." It does not specify the type of ground truth used beyond the implicit requirement of meeting established regulatory and engineering standards for similar devices.

8. The sample size for the training set:
   This device is a physical implant, not a machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established:
   As there is no training set for this type of device, this question is not applicable.

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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 – S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1), and for whom the device system is intended to be removed after solid fusion is attained.

Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.

The provided text describes the Moss Miami Spinal System Pin Nut (K023804), a spinal fixation device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The document is a 510(k) summary and an FDA clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.

Here's a breakdown of what can be extracted and what is missing from the provided text, relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical or qualitative acceptance criteria (e.g., tensile strength, fatigue life, torque strength, biocompatibility standards).
• Detailed performance results against those criteria. The document only states that "Data were submitted to characterize" the device.

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

Missing Information. The document mentions "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" but does not provide details about any specific test sets, their sample sizes, or the provenance of any data (e.g., country of origin, retrospective/prospective). This likely refers to mechanical testing data, which typically is conducted in a lab setting, not on patient data.

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

Missing Information. This type of information (expert review, ground truth establishment) is typically relevant for diagnostic or AI-driven devices. As this is a spinal implant, the "ground truth" would be established through mechanical testing standards, rather than expert review of images or clinical cases.

4. Adjudication Method for the Test Set:

Missing Information. Not applicable for a mechanical implant's performance testing.

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

Missing Information. Not applicable. The device is a spinal implant, not a diagnostic imaging or AI assistance tool that would involve human readers.

6. Standalone Performance Study:

Present (Implied): The statement "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" implies that some form of standalone performance (mechanical testing) was conducted on the device itself.

Missing Information:

• Details of the standalone performance studies (e.g., type of tests, parameters measured, results).
• Any comparison to a "human-in-the-loop" scenario, as the device is an implant.

7. Type of Ground Truth Used:

Implied: The "ground truth" for a device like this would be established by mechanical testing standards (e.g., ASTM or ISO standards for spinal implants) and material specifications (ASTM F-136, ASTM F-138). The device's materials are explicitly stated: "Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel." This indicates that material properties conforming to these standards would be part of the "ground truth."

Missing Information: Specific details of these mechanical tests and their corresponding "ground truth" (e.g., required fatigue cycles, pull-out strength).

8. Sample Size for the Training Set:

Missing Information. Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning or algorithms.

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

Missing Information. Not applicable, as there is no training set.

Summary of what the document does provide:

• Device Name: Moss Miami Spinal System Pin Nut
• Manufacturer: DePuy AcroMed, Inc.
• Date Prepared: August 2, 2002
• Predicate Device: Moss Miami Spinal System Titanium Pin Nut (K010742)
• Intended Use/Indications: Detailed for various spinal conditions, including scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, previously failed fusions, and degenerative disc disease. Specific indications for pedicle screw fixation in skeletally mature patients and severe spondylolisthesis (Grades 3 and 4) at L5-S1.
• Materials: ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
• FDA Clearance: K023804 granted on January 23, 2003, based on substantial equivalence to predicate devices.

In conclusion, the provided text is an FDA 510(k) summary and clearance letter, designed to demonstrate substantial equivalence for market clearance. It does not contain the detailed studies or acceptance criteria that would typically be found in a detailed device performance report or scientific publication for a new technology, especially not in the context of AI or advanced diagnostic algorithms. The "performance data" mentioned likely refers to mechanical and material data submitted to the FDA but not elaborated upon in this public summary.

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The MONARCH Spine System is a pedicle screw system 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 MONARCH Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

The MONARCH Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System Open and Closed Monoaxial Screws are designed to accept a 6.35mm diameter rod and are available in various lengths and diameters.
The MONARCH Spine System Open and Closed Hooks are designed to accept a 6.35mm rod and are available in a variety of geometries.
The MONARCH Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text describes a medical device submission (K023438) for the MONARCH Spine System, but it does not contain acceptance criteria for device performance or a study demonstrating that these criteria have been met.

Instead, the document primarily focuses on:

• Device Description: What the MONARCH Spine System is, including its components (monoaxial screws, hooks) and the materials it's made from (ASTM F-136 implant grade titanium alloy).
• Intended Use/Indications for Use: The specific medical conditions and patient populations for which the device is intended (e.g., immobilization and stabilization of spinal segments for various instabilities and deformities, treatment of severe spondylolisthesis, degenerative disc disease).
• Predicate Devices: Reference to previously cleared MONARCH Spine System devices (K021335, K010576).
• Regulatory Classification: The classification names, regulation numbers, and regulatory class (Class III) for the device.
• FDA Clearance: An FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Statement on Performance Data: A brief, general statement under "PERFORMANCE DATA:" that "Performance data were submitted to characterize the MONARCH Spine System." However, the actual performance data, acceptance criteria, or a description of the study itself are not included in this summary.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document only states that performance data "were submitted" but does not detail what those data were or against what criteria they were judged.

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