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The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system.

In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

The Alere NT-proBNP for Alinity i assay is an automated, two-step immunoassay for the in vitro quantitative determination of NT-proBNP in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample and anti-NT-proBNP coated paramagnetic microparticles are combined and incubated. The NT-proBNP present in the sample binds to the anti-NT-proBNP coated microparticles. The mixture is washed. Anti-NT-proBNP acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of NT-proBNP in the sample and the RLU detected by the system optics.

Despite the request for acceptance criteria and study proving the device meets said criteria, the provided document is a 510(k) summary for a diagnostic test (Alere NT-proBNP for Alinity i Reagent Kit). This type of document focuses on demonstrating substantial equivalence to a predicate device, and thus does not explicitly list "acceptance criteria" for performance in the same way one might find for a new medical device claiming superiority or non-inferiority.

Instead, the document details various performance characteristics of the device, comparing them to relevant standards (CLSI guidelines) and providing statistical data. It aims to show that the new device performs acceptably and similarly to a previously cleared device.

Therefore, I cannot extract a table of "acceptance criteria" as such a table is not explicitly presented. However, I can infer the implied acceptance criteria from the reported performance, specifically from the "No Significant Interference" and "within acceptable performance" statements in the nonclinical performance section, and the effectiveness of the cutoffs for diagnosis in the clinical performance. The "reported device performance" will be the actual numbers provided in the document.

Here's a summary of the available information, structured to address your points as much as possible given the document type:

Implied Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, explicit quantitative acceptance criteria are not stated in a dedicated table format. Instead, the device's performance characteristics are presented as evidence of substantial equivalence to a predicate device and adherence to recognized standards. The implied acceptance criteria are that the device demonstrates acceptable accuracy, precision, and clinical utility for its stated indications for use.

Here's a table summarizing key performance indicators that would implicitly serve as acceptance criteria given standard diagnostic device requirements:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Clinical Performance Study (test set): 2127 Emergency Department (ED) subjects.
     • Provenance: Multi-center prospective study across 17 collection sites in the US.
     • Demographics: 1030 (48.4%) female, 1097 (51.6%) male, age 19-97 years. Predominantly White (53.1%) and Black/African American (39.5%). 90.9% non-Hispanic/Latino.
   • Nonclinical Performance (examples):
     • Within-Laboratory Precision: 240 replicates (controls/panels).
     • Reproducibility: 360 replicates (controls/panels) per assay (across 3 sites).
     • Lower Limits of Measurement: n ≥ 60 replicates for LoB, LoD, LoQ.
     • Analytical Specificity/Interference: Each substance tested at 2 analyte levels (approximately 125 pg/mL and 2000 pg/mL).

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

   • The ground truth for the clinical study was an "adjudicated diagnosis" determined by a panel of board-certified cardiologists. The exact number of cardiologists on the panel is not specified in the provided text.

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

   • The document states "An adjudicated diagnosis was determined by a panel of board-certified cardiologists." It does not specify the exact adjudication method (e.g., majority vote, sequential review, etc.).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this document describes the validation of a quantitative in vitro diagnostic (IVD) reagent kit for measuring NT-proBNP levels using an automated chemiluminescent immunoassay (CMIA) system. It is not an AI-assisted diagnostic imaging device, so an MRMC study is not relevant to this submission. The "readers" are the automated analyzers and laboratory personnel interpreting numerical results.

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

   • This device is a standalone diagnostic test in the sense that it provides a quantitative NT-proBNP result. The assay itself is a fully automated process on the Alinity i system. The performance data presented (precision, linearity, limits, specificity, clinical performance tables) represent the performance of the device "standalone" in generating these quantitative results, which are then used by clinicians as an "aid in diagnosis." There isn't a "human-in-the-loop" component to the measurement itself, though medical professionals interpret the results in a clinical context.

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

   • For the clinical performance study, the ground truth for Heart Failure (HF) diagnosis was established by expert consensus (adjudicated diagnosis by a panel of board-certified cardiologists).

7. The sample size for the training set:

   • This document describes a 510(k) submission for an in vitro diagnostic reagent kit. Unlike AI/ML software, such devices typically undergo analytical and clinical validation studies with defined test sets but do not have a "training set" in the sense of machine learning algorithms. The development and optimization of the assay would have involved various internal samples and experiments, but these are not explicitly termed "training sets" and their size is not reported in this context.

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

   • As explained above, the concept of a "training set" with established ground truth, as typically applied to machine learning or AI models, does not directly apply to the regulatory submission type for this diagnostic reagent kit. The assay is based on chemical and biological principles (CMIA) rather than learned algorithms from large datasets.

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The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Axis Spine Technologies ALIF is an interfixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient.

The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device, alternately models with protrusions on the device endplates grip the adjacent vertebrae to resist migration and aid in expulsion resistance. The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The Axis Spine Technologies ALIF implant is composed of:

• one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• . one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• . one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• . three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• . one (1) cover plate manufactured from PEEK-Optima HA Enhanced.

This FDA 510(k) summary provides information on a medical device, the Axis Spine Technologies ALIF, an intervertebral body fusion device. Crucially, it does not describe acceptance criteria, a study that proves the device meets those criteria, or clinical performance data. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical (mechanical) testing.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Specific non-clinical tests performed and their implied acceptance criteria (meeting or exceeding predicate performance):

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

• Sample Size for Test Set: Not specified. The document refers to "studies" and "results" of "nonclinical testing" but does not provide sample sizes for these tests.
• Data Provenance: Not specified. These are non-clinical mechanical tests, so concepts like "country of origin" or "retrospective/prospective" don't directly apply in the same way they would for 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 is not established in the context of mechanical testing. The tests are performed against standardized ASTM methods.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies, not mechanical 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

• No. This is a medical device (intervertebral fusion device), not an AI/imaging device. MRMC studies are not relevant here.

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

• Not applicable. This is a physical medical implant, not an algorithm or software.

7. The type of ground truth used

• Not applicable. For these non-clinical tests, the "ground truth" is adherence to and performance within the parameters defined by the ASTM standards (e.g., F2077, F2267) and comparability to the predicate devices.

8. The sample size for the training set

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth for it.

In summary:

This document is a 510(k) summary for a physical medical device. It demonstrates substantial equivalence primarily through non-clinical (mechanical) testing results, showing the device performs comparably to or better than predicate devices according to established ASTM standards. It does not involve AI, clinical studies, or expert review of data in the way a diagnostic software device submission would.

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The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The ALIF System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Axis Spine Technologies ALIF is an inter-fixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient.

The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The subject device is indicated for use with supplemental internal spinal fixation (i.e., posterior pedicle screw and rodsystem).

The Axis Spine Technologies ALIF implant is composed of:

• one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.
• one (1) inferior endplate manufactured from titanium alloy (Ti-6AI-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
• one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to . ASTM F136 and ISO 5832-3.
• three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
• one (1) cover plate manufactured from PEEK-Optima HA Enhanced. ●

This document is a 510(k) summary for the Axis Spine Technologies ALIF system, an intervertebral body fusion device. It details the device's characteristics, intended use, and comparative testing against predicate devices to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided PDF:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, etc., and "reported device performance" are typical for diagnostic or AI-driven devices where a quantitative measure of performance against a ground truth is established.

However, this document describes a spinal implant (intervertebral body fusion device). For such devices, acceptance criteria primarily revolve around mechanical performance, biocompatibility, and substantial equivalence to existing devices, rather than diagnostic accuracy. The "study" proving acceptance criteria is primarily non-clinical (bench) testing and comparison to predicate devices.

Therefore, the table format for typical medical device AI/diagnostic performance metrics (sensitivity, specificity, etc.) is not directly applicable here. Instead, the acceptance criteria are based on biocompatibility and mechanical performance tests to ensure the device is safe and effective and performs comparably to or better than predicate devices.

Table of Acceptance Criteria (for a spinal implant) and Reported Device Performance:

The study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical (bench-top) performance testing program and a comparison against legally marketed predicate devices.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Non-Clinical): For mechanical testing, the "sample size" refers to the number of physical devices or components tested. While not explicitly stated with a specific number (e.g., n=X devices), the tests were conducted per relevant ASTM standards (ASTM F2077, ASTM F2267). These standards specify the number of samples required for each test (e.g., 6 samples for static compression, 3 for dynamic, etc.).
   • Data Provenance: The device is manufactured by Axis Spine Technologies Ltd, located in the United Kingdom. The testing would have been conducted in a laboratory setting, typically in the country of manufacture or a qualified testing facility. The data is retrospective in the sense that it's generated from manufactured devices for the purpose of regulatory submission, not from a patient population study.

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

   • For an implantable medical device undergoing non-clinical mechanical testing, "ground truth" is established by engineering standards and specifications (e.g., ASTM standards) and the objective physical measurements of the devices' performance.
   • There isn't a concept of a "human expert" establishing ground truth in the way a radiologist establishes ground truth for an AI diagnostic algorithm. The "experts" involved would be engineers and technicians conducting the tests in accordance with validated protocols and interpreting the results against the specified standards and predicate device performance. Their qualifications would be in biomedical engineering, mechanical engineering, or materials science.

3. Adjudication method for the test set:

   • Not applicable in the context of non-clinical mechanical testing. Adjudication is relevant for subjective assessments (like image interpretation) where multiple readers' opinions need to be reconciled. Here, the results are quantitative physical measurements.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC study is a clinical study typically used to evaluate the performance of diagnostic devices or AI algorithms when used by human readers. This submission is for an implantable spinal fusion device.

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

   • No. This is not an AI/algorithm-driven device. It is a physical implant.

6. The type of ground truth used:

   • For this device, the "ground truth" is defined by established engineering performance standards (ASTM) and the demonstrated performance characteristics of the legally marketed predicate devices. The goal is to show comparable or superior mechanical performance and material properties.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

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

   • Not applicable. See point 7.

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The ADVIA Centaur® Erythropoietin (EPO) assay is for in the quantitative measurement of exythropoitin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias.

The ADVIA Centaur EPO assay is a fully automated, one-step sandwich immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled monoclonal mouse anti-EPO antibody in the Lite Reagent. The Solid Phase consists of mouse anti-EPO monoclonal antibody-coated paramagnetic microparticles.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the ADVIA Centaur Erythropoietin (EPO) assay:

1. Table of Acceptance Criteria and Reported Device Performance

This table compiles information primarily from the "Summary of Non-Clinical Performance" and "Summary of Clinical Performance" sections.

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

• Linearity: Not specified, but involved three high EPO samples mixed with low EPO human serum.
• Dilution Recovery: 10 samples (containing high EPO levels: 618.63-986.07 mIU/mL).
• Detection Capability (LoD): 323 determinations using 10 low-level samples.
• Cross-reactivity: Not explicitly stated as a "sample size," but involved numerous cross-reactants (e.g., various plasma proteins, epoetin alfa, darbepoetin alfa).
• Interference: Not explicitly stated as a specific "sample size" for each interferent, but involved various substances tested at different concentrations.
• Precision: 7 pooled serum samples. For each sample, there were 80 observations (replicates of 2, in 2 runs/day, over 20 days).
• Specimen Collection Comparison: 65 samples (serum EPO values ranging from 4.39 - 707.81 mIU/mL).
• Method Comparison:
  • Study 1: 216 human serum samples (range: 3.29 – 691.60 mIU/mL).
  • Study 2: 100 human serum samples from US population (range: 4.45 - 407.74 mIU/mL).
  • Study 3 (Multi-site): 327 human serum samples (range: 3.55 - 596.81 mIU/mL), with ≥ 100 samples per site.
• Expected Values (Adult): 251 apparently healthy subjects (128 males, 123 females), older than 21 years of age.
• Expected Values (Pediatric): 266 apparently healthy children (2 to

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The ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measuremt of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

The ADVIA Centaur CALCT Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CALCT Lite Reagent and Solid Phase reagent, and one set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). ADVIA Centaur CALCT Calibrator Assigned Value Card and barcode labels and ADVIA Centaur CALCT Master Curve Card are also included in the kit. The ADVIA Centaur CALCT assay is a fully automated, two-step immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium- ester-labeled recombinant antibody as the Lite Reagent. The Solid phase consists of anti-calcitonin mouse monoclonal antibody-coated paramagnetic microparticles.

Here's a summary of the acceptance criteria and study information for the ADVIA Centaur® Calcitonin (CALCT) assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Linearity: Not explicitly stated as a "test set" in the context of patients, but rather an analytical study using two samples containing high levels of calcitonin mixed with analyte-free human serum. The number of measurements performed for linearity or dilution recovery is not explicitly stated.
• Dilution Recovery: Fourteen samples containing high levels of calcitonin.
• Detection Capability (LoD): 125 determinations using 6 low-level samples.
• Precision: Five pooled serum samples, tested in replicates of 2, in 2 runs per day, over 20 days, yielding 80 observations per sample (400 total observations for the 5 samples).
• Cross-reactivity: Tested with individual cross-reactants. Number of samples per reactant not specified.
• Interference: Tested using two levels of calcitonin with various interfering substances. Number of samples not specified. For biotin, samples containing different calcitonin levels were tested.
• Specimen Collection Comparison: 60 samples.
• Method Comparison: 97 human serum samples.
• Expected Values (Reference Intervals): 240 apparently healthy subjects (120 males, 120 females), age range 22-79 years.

Data Provenance: The document generally describes these as studies performed by the manufacturer, Axis-Shield Diagnostics Limited, in support of their 510(k) submission. It does not provide specific country of origin for the patient/human serum samples, nor explicitly state if they are retrospective or prospective. However, based on the nature of these analytical and clinical validation studies for a diagnostic device, they are typically conducted prospectively to evaluate the device's performance.

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

This is an in vitro diagnostic (IVD) device designed for quantitative measurement of calcitonin. The "ground truth" for such devices is established through laboratory methods and standards (e.g., traceable reference materials, expert consensus on method accuracy, or clinical outcomes for reference ranges).

• For analytical performance (linearity, detection capability, precision, etc.): Ground truth is established by the analytical reference methods, international standards (e.g., WHO 2nd IRP 89/620), and carefully prepared samples with known concentrations. No "experts" in the sense of clinicians or radiologists are typically involved in establishing this type of ground truth.
• For expected values/reference intervals: While derived from human subjects, the calculation of reference intervals is a statistical process (97.5th percentiles) rather than an "expert" adjudication of individual cases. The "apparently healthy subjects" serve as the basis for this ground truth.

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

Not applicable. This is not an image-based diagnostic or clinical decision support AI where human experts adjudicate classifications. The device measures a biomarker quantitatively.

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 an in vitro diagnostic assay, not an AI-assisted diagnostic device for human readers/clinicians reading images or other complex data.

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

Yes, the studies described (linearity, precision, detection capability, interference, method comparison) are all standalone performance evaluations of the ADVIA Centaur CALCT assay. The device provides a quantitative measurement of calcitonin from a human serum sample without human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the immunoassay's measurement and calculation protocols.

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

• Analytical Performance: Primarily analytical standards (e.g., CLSI protocols EP06-A, EP17-A2, EP05-A3, EP07-A2), international reference materials (WHO 2nd IRP 89/620), and known concentrations in spiked or diluted samples.
• Expected Values (Reference Intervals): Derived from samples from a population of apparently healthy subjects, with the normal range defined statistically (97.5th percentiles).
• Method Comparison: Comparison against a "comparable method" (the Roche Elecsys/Cobas® Calcitonin assay, which is the predicate device), where the predicate serves as the comparative "ground truth" for demonstrating equivalence.

8. The sample size for the training set:

Not explicitly stated. For an IVD such as this, the development ("training") of the assay involves various stages of optimization and formulation. The provided document focuses on the validation or test data used to demonstrate performance for regulatory purposes. The term "training set" is more commonly used in machine learning. However, if interpreted as samples used during the development phase to establish assay parameters, that information is not detailed in this summary.

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

Not explicitly stated. Similar to point 8, this refers to assay development. Ground truth during development would typically involve using highly characterized samples, reference materials, and comparing results to established methods to refine the assay's chemical and procedural parameters.

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The Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.

The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.

The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.

Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.

The provided document is a 510(k) summary for the Axis Chena Cervical PEEK Spacer System and focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing rather than clinical studies or reader studies. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and clinical efficacy will not be directly applicable or available in this specific document.

However, I can extract and infer information relevant to its acceptance criteria and the engineering performance testing showing it meets those criteria.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to predicate devices through mechanical performance testing according to established ASTM standards. The reported performance is that the device met these standards.

Study Details (as inferable from the document)

Because this is a 510(k) submission primarily relying on mechanical testing for substantial equivalence, clinical study details (like MRMC, human-in-the-loop, etc.) are not part of this submission and are therefore not available in the provided text.

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

   • Sample Size: Not explicitly stated for each test, but standard engineering protocols for ASTM testing would involve a sufficient number of samples (e.g., typically N=5-6 per test condition).
   • Data Provenance: The testing was performed by the manufacturer, Axis Orthopaedics, or a contracted lab. The document does not specify the country of origin for the testing or whether it was retrospective or prospective in a clinical sense. It's prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

   • Not Applicable. For mechanical performance testing of an implant, "ground truth" is established by the well-defined parameters and methods outlined in the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would. The device's performance is objectively measured against the standard's specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data. For mechanical testing, the results are quantitative and objective measurements against established criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is a type of clinical study involving human readers evaluating images or data. This 510(k) is based on mechanical testing, not a clinical MRMC study.

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

   • Not Applicable. This device is a passive mechanical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

6. The Type of Ground Truth Used:

   • Mechanical Test Standards and Predicate Performance: The "ground truth" for this submission is adherence to recognized industry standards (ASTM F2077-14 and F2267-11) for intervertebral body fusion devices, and demonstrating that the device performs equivalently to its legally marketed predicate devices under these conditions.

7. The Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical implant; therefore, no training set was used.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. See point 7.

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The AXIS 5.5 LUMBAR PEDICLE SCREW SYSTEM is intended for posterior, non-cervical fixation of skeletally mature patients as an adjunct to fusion 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; pseudarthrosis; and/or failed previous fusion.

The AXIS 5.5 LUMBAR PEDICLE SCEW System consists of a variety of shapes and sizes of rods, screws, Crosslink plates, which can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case.

The AXIS 5.5 LUMBAR PEDICLE SCEW System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2.

This document is a 510(k) premarket notification for the AXIS 5.5 Lumbar Pedicle Screw System. It describes the device, its intended use, and provides evidence of substantial equivalence to predicate devices. However, it does not contain information about an AI/ML-driven medical device or studies related to its acceptance criteria and performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-driven device based on the provided text. The document pertains to a mechanical orthopedic implant.

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The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.

This document is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. The information provided is not about an AI/ML powered device, but a physical medical implant. Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML validation studies, are not applicable here.

However, I can extract the information relevant to the performance assessment of this physical device as presented in the document itself.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are related to its mechanical performance, demonstrating equivalence to a predicate device based on specific ASTM standards.

Study Proving Device Meets Acceptance Criteria:

A performance assessment was conducted through mechanical testing.

• Study Type: Mechanical performance testing.
• Standards Used: ASTM F1717-15 and ASTM F543-13e1.
• Objective: To demonstrate that the Axis Anterior Cervical Plate System is equivalent to a predicate device with respect to the testing recommended in these ASTM standards.

The following sections are not applicable as this is not an AI/ML device:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to physical testing of the device components, not data analysis.
• 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 a physical device is established through engineering and material science specifications and testing.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth here is the established mechanical performance standards as outlined in ASTM F1717-15 and ASTM F543-13e1, and the performance of the predicate devices.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The ADVIA Centaur AB12 assay is a fully automated, two-step direct immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.

Here's an analysis of the provided text regarding the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay, structured to address your specific questions about acceptance criteria and the supporting study:

It's important to note that this document is a 510(k) summary, which is a high-level overview. It describes a modification to an already cleared device (K160757), primarily focusing on a change in calibration traceability. Therefore, detailed study protocols and raw data are not typically included in this summary. The summary focuses on demonstrating that the modified device is substantially equivalent to the predicate device and that the modification did not negatively impact its performance.

Since this is a summary of a modification intended to show substantial equivalence, the "acceptance criteria" discussed are largely in the context of ensuring the modification did not degrade performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, the specific numerical acceptance criteria for each test are not explicitly provided in this 510(k) summary. It lists the types of tests performed and implies that the results were satisfactory.

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

The summary does not explicitly state the sample sizes used for the various validation tests (Accuracy, Linearity, Precision, Detection Limits, Recovery, Proficiency, or Reference Range).

• Data Provenance: Not explicitly stated, but the reference range study provides a mean and 95% central reference interval for an "asymptomatic population," implying human serum samples. The device itself is for in vitro diagnostic use in human serum. The data would have been collected in the course of validating the device. The manufacturer is Axis-Shield Diagnostics Ltd. in Scotland, UK, so it's plausible the data collection occurred there or in other regions where they conducted studies. The study is retrospective in the sense that these tests are performed after the device (or its modification) has been developed, but the sample collection itself for the reference range could be prospective.

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

This type of information is not applicable and not provided in the context of this device. This is an in vitro diagnostic (IVD) assay that measures a biomarker (holotranscobalamin) directly. The "ground truth" for the test set is established by the analytical reference methods or reference materials (like the WHO International Standard), not by human experts interpreting images or complex clinical scenarios.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical data where there might be inter-reader variability. For an IVD assay, the result is a quantitative measurement, and the "ground truth" is based on the accuracy and precision of the analytical measurement itself, often against a validated reference method or material.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with and without AI assistance, especially in radiology or pathology. This device is an automated IVD assay, not an AI-assisted human interpretation tool.

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

This device is a standalone algorithm/assay in the sense that it performs the measurement automatically without human intervention during the measurement process. The "performance" mentioned (accuracy, linearity, precision, etc.) are all standalone performance metrics of the assay itself. There is no "human-in-the-loop" once the sample is loaded onto the ADVIA Centaur XP system for this specific measurement.

7. The Type of Ground Truth Used

The ground truth for evaluating the performance of this IVD assay is primarily based on:

• Reference Materials: Specifically, the WHO International Standard for Holotranscobalamin (NIBSC Code 03/178) is highlighted as the new traceability standard for calibration. This serves as a primary ground truth for accurate measurement.
• Comparative Methods: The "Accuracy by correlation" likely involved comparing results from the modified device with those obtained using a reference method or the predicate device.
• Defined Concentrations: For tests like dilution linearity, precision, and detection capability, samples with precisely known or established concentrations of holotranscobalamin are used.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" sample size as this is not a machine learning or AI algorithm in the contemporary sense that would require a separate training phase with a distinct dataset for model building. The calibration process implicitly "trains" the device to measure correctly against known standards. The calibration itself uses "2-point Calibration using 2 level calibrators" (Low – 19 pmol/L, High - 121 pmol/L). However, this is not a "training set" in the context of complex ML models.

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

Given that there isn't a traditional "training set" for a machine learning model, the "ground truth" for the calibration materials (which serve a similar function of establishing correct performance parameters) is established through:

• Reference to the WHO International Standard (NIBSC Code 03/178): The primary modification in this 510(k) is to make the calibration traceable to this international standard. This standard itself would have been value-assigned through a rigorous international collaborative study.
• Internal Reference Material: The predicate device used an "Internal reference material; recombinant holotranscobalamin and phosphate buffer with protein (bovine) stabilizers." This internal standard would have been characterized and assigned values through the manufacturer's own internal assay development and validation processes, likely against an existing recognized reference method or material.

In summary, this 510(k) pertains to a minor modification (calibration traceability) of an existing in vitro diagnostic test. The evaluation focuses on ensuring the modification did not alter the fundamental performance characteristics, and the "acceptance criteria" are implied to be that the modified device performs comparably to the predicate and meets standard analytical performance requirements for IVDs. The "study" refers to a series of analytical verification and validation tests rather than clinical trials with human readers or AI algorithms.

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