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The Mercury Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws. Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone.

Screws, rods, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.

The provided 510(k) summary for the Mercury Spinal System does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a regulatory submission for premarket notification (510(k)) of a medical device. It focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than providing the type of performance study details requested for an AI/ML device.

Here's why the specific information requested cannot be extracted from this document:

• Device Type: The Mercury Spinal System is a mechanical implant (screws, rods, staples) for spinal fixation, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concept of "accuracy," "sensitivity," "specificity," "reader studies," or "ground truth" as typically applied to AI/ML devices is not relevant in this context.
• Performance Data: The document states, "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use." This is the extent of the performance data description. It implies ISO/ASTM standard mechanical tests (e.g., fatigue, static strength, torsional strength) were performed, but specific acceptance criteria, test results, or study designs are not provided in this summary.
• Clinical Studies: For mechanical implants like this, clinical data (human subjects) is often not required for a 510(k) if substantial equivalence can be demonstrated through predicate devices and bench testing. There is no mention of human clinical trials, and thus no details on patient cohorts, expert readers, or ground truth establishment.

Therefore, I cannot populate the requested tables and sections with information from this document.

To answer your prompt with the provided input, I would have to state that the requested information is not present in the given 510(k) summary, as it pertains to an entirely different type of device and regulatory submission framework.

If you have a 510(k) summary for an AI/ML-powered medical device, I would be happy to analyze that for the requested details.

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The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment. (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The Savannah Lumbar Percutaneous Stabilization System is comprised of a variety of pedicle screws sizes, couplers, a ball swivel, rods and locking nuts that can be uniquely fitted for each individual case. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The provided text is a 510(k) summary for the Savannah Lumbar Percutaneous Stabilization System (SLPSS). It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document states:

"The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."

This implies that the device's performance was compared to existing, legally marketed devices (predicates) rather than against specific, predefined acceptance criteria through a standalone clinical or performance study with detailed metrics. The regulatory pathway chosen, a 510(k), relies on demonstrating "substantial equivalence" to a predicate device, which often involves comparing technical characteristics and performance data to show that the new device is as safe and effective as the predicate.

Therefore, for your request, the following information is largely not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is a surgical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a surgical implant.
7. The type of ground truth used: Not applicable, as it's not a diagnostic device.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

• Device Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS)
• Regulatory Pathway: 510(k) Premarket Notification (K072116)
• Claim of Performance: "The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
• Predicate Devices Listed:
  • Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, K982987)
  • DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, K933881)
  • U&I Optima Spinal System (K031585)
  • Stryker Spine Xia Spinal System (K001319, K984251, K951725)
• Nature of Testing: "Pre-clinical testing" was performed to demonstrate substantial equivalence, but details of this testing (e.g., in-vitro, mechanical, benchtop) are not provided in this summary.

Conclusion:

The provided document relies on showing substantial equivalence to predicate devices based on pre-clinical testing, rather than presenting a study with specific acceptance criteria as you've requested for a device that might involve diagnostic performance or AI. Therefore, most of the detailed information you are seeking is not available in this 510(k) summary.

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The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

The Stryker Spine Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks, Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.

This submission is intended to address a line extension to Xia " 4.5 Spinal System. The line extension includes:

• A new size dual staple component in both a rostral and a caudal configuration.
• A new polyaxial cross connector in sizes small, medium, large, and extra large, and
• A new longitudinal rod-to-rod connector to join a Ø 4.5 mm rod from the Xia" 4.5 ■ Spinal System to a Ø 6.0 mm rod from the Xia® Spinal System (K013688, K984251), DIAPASON The Spinal System (K951725), and OPUS "M Spinal System (K993402 & K030369).

This submission describes a line extension to an existing spinal system, not a device that would typically involve acceptance criteria and a study to prove performance in the way an AI/ML diagnostic device would.

Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies) are not applicable to this type of device (a spinal fixation system).

Here's an interpretation based on the provided document and the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A): This is a mechanical device, not typically evaluated with "test sets" of data in the sense of AI/ML or diagnostic devices. The "test set" would consist of samples of the components for mechanical testing.
• Provenance: This information is not detailed in the summary, but given it's a medical device manufacturer, it would typically be internal testing performed by Stryker Spine.

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

• Not Applicable (N/A): No "ground truth" in the diagnostic or AI sense is established for this type of device. Performance is determined by engineering specifications and mechanical testing standards.

4. Adjudication method for the test set

• Not Applicable (N/A): Adjudication methods are relevant for subjective evaluations, typically in diagnostic or AI studies. For mechanical testing, results are typically quantitative and compared against predefined engineering standards.

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 (N/A): This is for a spinal fixation system, not an AI/ML diagnostic and does not involve human readers or AI assistance.

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

• Not Applicable (N/A): This is for a spinal fixation system, not an AI/ML algorithm.

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

• Not Applicable (N/A): For mechanical devices like this, the "ground truth" is defined by engineering specifications, material properties, and performance standards established through industry-recognized mechanical testing (e.g., fatigue, strength, torsional stability). The regulatory body (FDA) assesses if these tests demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable (N/A): No "training set" in the AI/ML sense is used for this device.

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

• Not Applicable (N/A): No "ground truth" or "training set" as understood in AI/ML is relevant for this device.

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The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

• Long and short curve scoliosis .
• Vertebral fracture or dislocation .
• Spondylolisthesis .
• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
• Previously failed fusion
• Spinal tumor .

Pedicular Use:

• When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
• In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.

The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.

This document describes a Special 510(k) submission for a device modification to the Osteonics® Spinal System, specifically for the Diapason Combo and the use of Xia 6mm diameter rods with the system. The submission does not contain information typically found in studies for AI/ML-based medical devices. Instead, it focuses on the mechanical performance of modified spinal implant components. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

The "study" referenced in this document is a series of mechanical tests designed to demonstrate the comparable performance of the modified components to their predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a mechanical engineering study. The "sample size" would refer to the number of individual test specimens of the device components. This detail is not provided in the summary.
• Data Provenance: Not applicable. This is a laboratory study involving physical testing of materials/components, not patient data from a specific country or retrospective/prospective collection.

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

Not applicable. "Ground truth" in this context refers to established mechanical engineering standards and measurements, not expert clinical interpretation of medical data. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, operating under established protocols.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a clinical study requiring adjudication of expert opinions. The determination of "comparable" or "acceptable" performance would be based on engineering analysis and adherence to pre-defined test protocols and measurable criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No.
• Effect Size of AI: Not applicable, as this is not an AI-based device.

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

Not applicable, as this is not an AI-based device.

7. The type of ground truth used

The "ground truth" for this engineering study is based on:

• Established Mechanical Engineering Principles and Standards: This includes accepted methods for static and fatigue testing of spinal implants.
• Performance of Predicate Devices: The key ground truth for comparison is the documented and accepted mechanical performance of the previously cleared Osteonics® Spinal System components (the OSS Screw Blocker and Cap) and the Xia 6mm diameter rods. The goal is to show "comparable" or "acceptable" properties relative to these established devices.

8. The sample size for the training set

Not applicable. This is a mechanical testing study, not a machine learning study that requires a training set.

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

Not applicable, as this is not a machine learning study.

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The Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants - Oplates 2000 (and other forms of the product) The mage Faller of Drugs of Audie plus Tryoyano of the major metabolites of drugs of also Phencyclidine, Benzodiazepines, Cocain Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antideoressants in urine,

This test provides only a preliminary test result. A more specific atternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatographylmass spectrometry (GCMS) is the preferred Clinical consideration and Other chemical confirmation methods are available. confirmatory method. professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The tricyclic test is a qualitative screening test. A negative result does not ellminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/ml. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound.

Not Found

The provided document describes a 510(k) premarket notification for a device called "Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants and Opiates 2000" (and related variations). While the document lists the "Indications for Use" and the "cut off concentrations" for various drugs, it primarily focuses on the FDA's substantial equivalence determination and regulatory aspects.

The document does NOT contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment that would typically be reported in a study proving the device meets acceptance criteria.

The section titled "The above products have the screening cut-off concentrations as outlined below:" and the subsequent table define the performance specifications or target concentrations at which the device is expected to detect the drugs. These are not the acceptance criteria for a study proving performance, but rather the operational thresholds of the device.

Without the actual study report, it's impossible to fully answer your request. However, I can infer the acceptance criteria based on the information provided (the cut-off concentrations) and explain what kind of study would typically be done for such a device, and what information would ideally be in a study report.

Inference of Acceptance Criteria and a Hypothetical Study Description:

Based on the nature of the device (a rapid immunoassay for drugs of abuse), the acceptance criteria would typically relate to its ability to correctly identify the presence or absence of drugs at or above the specified cut-off concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):

Since the document only provides the target cut-off concentrations, the acceptance criteria would likely be defined around sensitivity and specificity at these concentrations.

Note: The actual acceptance criteria might also include parameters like agreement within a certain percentage of the cut-off, or detection within a certain analytical range.

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

• Sample Size: The document does not specify the sample size for the test set. For a multi-analyte immunoassay, studies typically involve hundreds to thousands of samples, often stratified to include concentrations near the cut-off, well above the cut-off, and negative samples, as well as samples with potential cross-reactants.
• Data Provenance: Not specified in the document. For such devices, clinical samples from various populations (e.g., diverse demographics, different geographic locations to capture varying drug use patterns) would be ideal. Whether retrospective or prospective is also not mentioned. Prospective collection would be preferred for avoiding bias.

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

• Number of Experts: Not specified.
• Qualifications of Experts: For drug of abuse testing, "experts" in the context of ground truth would typically refer to the highly trained laboratory personnel performing the gold standard confirmatory tests, not necessarily clinical experts. The ground truth method (GC/MS) is intrinsically the "expert" here.

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

• Adjudication Method: Not specified. For analytical studies, a formal adjudication process like 2+1/3+1 is usually not directly applicable. The "adjudication" is inherent in the confirmatory method's results. If multiple runs of the confirmatory method were done, then a consensus approach might be employed, but it's not medical expert adjudication.

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:

• MRMC Study: This device is a diagnostic test kit for drugs of abuse. It is not an AI-assisted diagnostic imaging device. Therefore, an MRMC study or AI assistance is not applicable to this type of device. The "reader" is typically a laboratory technician interpreting a color change or a machine reading it.

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

• Standalone Performance: Yes, the fundamental performance evaluation of such a device is its standalone performance. The document implies this through the cut-off concentrations. The device itself (the panel) yields a result based on chemical reactions. The "algorithm" here is the chemical reactivity. Its performance is measured against confirmatory methods (GC/MS).

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

• Ground Truth Type: As explicitly stated in the document: "A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Other chemical confirmation methods are available."
  • Therefore, the ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS) or other validated chemical confirmation methods. This is the gold standard for drug detection and quantification in urine.

8. The sample size for the training set:

• Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. For an immunoassay, the "training" phase involves optimizing the assay reagents and conditions during development to achieve the desired sensitivity, specificity, and cut-off levels. This isn't typically quantified as a distinct "training set size" in the same way as an AI model.

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

• Ground Truth for Training Set: Not applicable in the AI sense. During the development and optimization of the immunoassay, various spiked and clinical samples would be tested, and their true concentrations (ground truth) would be established using a similar, highly accurate analytical method like GC/MS to guide the optimization of the immunoassay's performance characteristics.

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