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The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.

The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing.

There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.

The provided document, a 510(k) summary for the PrimeSight™ UNITY 9000 Series Video Processors, describes the device's functional performance and compliance with various standards. However, it explicitly states that clinical data was not used to demonstrate substantial equivalence because the subject device and predicate device are considered very similar in design and functionality. This means the study did not involve human readers, ground truth establishment, or multi-reader multi-case comparative effectiveness.

Therefore, many of the requested details about acceptance criteria related to clinical performance metrics and associated study parameters (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies) are not applicable or provided in this document.

The acceptance criteria mentioned are primarily focused on functional performance, compliance with electrical safety and electromagnetic compatibility standards, software requirements, environmental testing, and usability.

Here's a breakdown of the available information:

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

Since the document focuses on demonstrating substantial equivalence through non-clinical testing, specific quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) are not stated, nor is there reported clinical device performance in terms of these metrics.

Instead, the "acceptance criteria" are implied by the successful completion and positive results of the various engineering and regulatory compliance tests. The "reported device performance" is that the device meets these criteria and is "safe and effective and performs in a manner making it substantially equivalent to its predicate device."

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical testing. The "test set" consisted of the physical device and its components undergoing various engineering, software, and regulatory compliance tests. There is no mention of a "data provenance" in the clinical sense (e.g., country of origin, retrospective/prospective).

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 the context of clinical studies, refers to definitive diagnoses or findings. This document describes engineering and regulatory compliance testing. Usability evaluation (TR 013-18) was performed, which likely involved human users, but details on the number or qualifications of "experts" to establish a clinical ground truth are not provided because it's not a clinical study.

4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve disagreements among human readers or evaluators when establishing ground truth. This document does not describe such a study.

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, a MRMC comparative effectiveness study was not done. The device is a video processor for endoscopes, not an AI-powered diagnostic tool, and the document explicitly states that "Clinical data was not used to demonstrate substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a video processor, which is inherently a "standalone" piece of hardware and software designed to display and manage images from endoscopes for human interpretation, not an algorithm providing diagnostic output on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the clinical sense. The "ground truth" for the various engineering and regulatory compliance tests would be the established specifications, standards, and documented requirements that the device needed to meet.

8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring a dataset for model training.

9. How the ground truth for the training set was established:
Not applicable, as there was no training set.

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The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.

The Cogent Lateral Interbody consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.

The Cogent Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.

The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.

The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.

This document is a 510(k) summary for the Cogent Lateral Interbody System, an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to existing predicate devices. Consequently, it does not contain details about acceptance criteria, the study proving the device meets those criteria, or clinical performance metrics in the way typically required for AI/ML device evaluations.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the Cogent Lateral Interbody System is substantially equivalent to predicate devices (Cogent Med-LIF System and Cogent Med-LIF XL System) based on indications for use, technological characteristics, and performance testing.
• Device Description: Materials (PEEK, Ti-6Al-4V, Tantalum), dimensions, and general design.
• Non-Clinical Testing: A "Cadaveric Usability Study" is mentioned, but no details of acceptance criteria or performance results are provided.
• Clinical Testing: Explicitly states, "No clinical studies were performed."

Therefore, based on the provided text, I cannot answer the specific questions regarding acceptance criteria, study methodologies, and performance metrics as they would apply to an AI/ML device or a device requiring new clinical efficacy data. The information requested (Table of acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this 510(k) summary because the approval is based on substantial equivalence to existing devices that have already demonstrated safety and effectiveness, rather than novel clinical performance data for this specific device.

The only "study" mentioned is a "Cadaveric Usability Study" under non-clinical tests, and no details about its methodology, acceptance criteria, or results are provided.

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The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.

The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm.

The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.

The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.

The document provided is a 510(k) premarket notification from the FDA for a medical device called Cogent Med-LIF XL, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and human reader performance is not available in the provided text.

Based on the available information, here's a breakdown:

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

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide a direct comparison of the Cogent Med-LIF XL's performance against specific numerical benchmarks. Instead, it relies on demonstrating substantial equivalence through bench testing to a legally marketed predicate device.

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

This information is not provided because no clinical studies were performed. The submission relies solely on non-clinical (bench) testing. Therefore, there is no test set in the context of clinical data, and no data provenance from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as no clinical studies were performed, and thus no ground truth based on expert review of patient data was established for a test set. The evaluation was limited to bench testing.

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

This information is not applicable as no clinical studies were performed to generate a test set requiring 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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.

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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an algorithm or software device.

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

The 'ground truth' for this submission is based on engineering standards and performance established by the predicate device. For the bench tests, the "ground truth" would be the fulfillment of the specified ASTM F2077 mechanical testing requirements, and the "truth" that the device performs comparably to the predicate.

8. The sample size for the training set

This information is not applicable as no machine learning or AI models were used. The device is a physical implant, not a software algorithm requiring a training set.

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

This information is not applicable as no machine learning or AI models were used, and therefore no training set was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" conducted for the Cogent Med-LIF XL device was exclusively non-clinical bench testing.

• Tests Performed:
  • ASTM F2077 - Static Shear Compression
  • ASTM F2077 - Dynamic Shear Compression
• Purpose: To demonstrate mechanical performance and substantial equivalence to the predicate device (Cogent Med-LIF System, K132738).
• Outcome: The non-clinical testing "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
• Materials Testing: The materials (PEEK, Ti-6Al-4V, Tantalum) were specified to conform to their respective ASTM standards (F2026, F1472, F560), implying their suitability and established performance.
• Absence of Clinical Data: The submission explicitly states, "No clinical studies were performed." The FDA's 510(k) clearance in this case is based on the device having the same indications for use, technological characteristics, and comparable performance through non-clinical testing as a legally marketed predicate device.

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The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers. The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm. The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.

The provided document describes the Cogent Med-LIF, an intervertebral body fusion device, and its performance testing for a 510(k) submission. It does not describe a study involving AI, software or an analytical device. Therefore, it is impossible to answer the following sections, as they are not presented in the document:

• Acceptance criteria and reported device performance related to a diagnostic or analytical AI/software device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the physical device's performance testing and its overall conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the physical device, Cogent Med-LIF, the "acceptance criteria" are implied by compliance with ASTM standards and demonstrating performance comparable to legally marketed predicates. The "reported device performance" is a general statement that the device met these criteria.

Summary of the Study:

The document describes bench testing and a cadaveric implantation study for the Cogent Med-LIF device.

• Bench Tests: These tests focused on the mechanical properties of the device, adhering to established ASTM standards (F2077, F2267, and a draft expulsion standard). The specific acceptance criteria for these tests would be the performance benchmarks defined by these ASTM standards or comparative performance to the predicate devices.
• Cadaveric Implantation Study: This study's purpose was to confirm that autogenous bone graft could be adequately delivered using the Cogent Med-LIF, specifically when compared to a legally marketed predicate device.

Overall Conclusion:
The manufacturer concluded that "mechanical and non-clinical testing of the Cogent Med-LIF device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This statement serves as the final "reported device performance" and meets the overarching "acceptance criteria" for a 510(k) submission, which is to demonstrate substantial equivalence to a predicate device.

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The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; Help control minimal bleeding following surgery or trauma; Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. Upon placement, the Nasal/Epistaxis Pack absorbs fluids in the field and swells and conforms to the mucosal tissue/treatment site surfaces to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.

The provided document is a 510(k) summary for the Nasal/Epistaxis Pack, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with specific acceptance criteria that an AI/device performance would need to meet.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, training set size) is not applicable to this type of regulatory submission or the device it describes.

A 510(k) submission primarily focuses on comparing the new device's characteristics and performance to existing predicate devices. The "safety and effectiveness information" section in this document refers to comparative performance data demonstrating adequate device performance by showing substantial equivalence, not results from a study designed to meet specific performance metrics against a defined standard or ground truth as would be found in an AI/algorithm-focused study.

Here's an overview of what the document does provide, and why your specific questions are not directly answerable from this text:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/diagnostic device. The "acceptance criteria" for a 510(k) submission are typically demonstrating substantial equivalence to a predicate device across various characteristics (e.g., indications for use, design, materials, method of action, sterility, biocompatibility).
• Reported Device Performance: The document states, "In addition, comparative performance test data demonstrated adequate device performance," and "The review of the indications for use and technical characteristics provided demonstrates that the Nasal/Epistaxis Pack is substantially equivalent to the predicate devices." This is a qualitative statement of meeting the equivalence criteria rather than specific numerical performance against a pre-defined metric. The table provided is a comparison of characteristics between the new device and predicate devices.

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

• Not Applicable. This device is a physical sterile pack, not an AI or diagnostic tool that uses a "test set" of data in the typical sense. The "comparative performance test data" mentioned likely refers to bench testing (e.g., absorption capacity, degradation rates) or biocompatibility tests, not a clinical trial with a "test set" for performance evaluation against a diagnostic ground truth.

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 the context of AI/diagnostic device evaluation, refers to the definitive determination of a condition (e.g., confirmed disease or pathology) used to assess the device's accuracy. This concept does not apply to a physical medical device like the Nasal/Epistaxis Pack.

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

• Not Applicable. See point 3.

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. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often the impact of AI assistance. This device is not a diagnostic tool or AI.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Not Applicable. See point 3.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not Applicable. See point 8.

Summary of what is provided in the K113585 document:

• Device Name: Nasal/Epistaxis Pack
• Product Description: Sterile, single-use co-polymer of polyethylene glycol (PEG) and chitosan, provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. It absorbs fluids, swells, conforms to tissue, separates tissues to prevent adhesions, controls minimal bleeding, and aids in healing.
• Indications for Use:
  • As a space-occupying packing in nasal/sinus surgery to:
    • Separate tissue/structures compromised by surgical trauma.
    • Separate and prevent adhesions between mucosal surfaces.
    • Help control minimal bleeding following surgery or trauma (by tamponade effect, blood absorption, platelet aggregation).
    • Act as an adjunct to aid in the natural healing process.
  • As a nasal packing to treat epistaxis.
• Predicate Devices:
  • Nasopore® manufactured by Polyganics BV (K052099)
  • Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation (K043035)
  • Rhinocell® Nasal Packings manufactured by Boston Medical Products, Inc. (K972459)
  • MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic Xomed Inc. (K041381)
  • MeroGel™ Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed Inc. (K002972)
• Basis for Substantial Equivalence: The Nasal/Epistaxis Pack shares the same indications for use, device operation, overall technical and functional capabilities with the predicate devices. Comparative performance test data demonstrated adequate device performance in supporting this claim of substantial equivalence. The provided table details the comparison of characteristics, including product codes, regulations, ingredients, method of action/removal, sterility, biocompatibility, and how supplied, across the new device and its predicates.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.

Uses:

The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy. Tec Automated EIA instrument.

For in vitro diagnostic use only.

Not Found

The provided text is a 510(k) clearance letter for the "Autostat II Rheumatoid Factor IgA ELISA" device, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data that proved the device met those criteria.

Therefore, most of the requested information cannot be extracted from the given text. The relevant sections from the prompt that can be addressed from the text are the device name and its intended use.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be answered from the provided text. The letter states the device is "substantially equivalent" to a predicate device, but it does not specify the performance acceptance criteria or report the actual performance metrics of the Autostat II Rheumatoid Factor IgA ELISA.

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

• Cannot be answered from the provided text. The document does not describe the test set size or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be answered from the provided text. This information would typically be in a study report, not a regulatory clearance letter.

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

• Cannot be answered from the provided text. This detail is not present.

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

• Cannot be answered from the provided text. This device is an ELISA (Enzyme-linked immunosorbent assay), a laboratory diagnostic test, not an image-based device that would typically involve human readers or AI assistance in the way described for MRMC studies.

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

• Partially addressed indirectly. As an ELISA test, its performance is typically "standalone" in that it produces a result without direct human interpretation in the same way an imaging AI might. However, the document doesn't explicitly state whether a standalone performance study was conducted or its results.

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

• Cannot be answered from the provided text. While the device aids in the diagnosis of rheumatoid arthritis, the method used to establish the ground truth in any underlying studies is not disclosed.

8. The sample size for the training set

• Cannot be answered from the provided text. This information is not included.

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

• Cannot be answered from the provided text. This information is not included.

Based on the provided text, here's what can be stated:

• Device Name: Autostat II Rheumatoid Factor IgA ELISA (also referred to as Autostat Rheumatoid Factor IgA ELISA)
• Indications for Use: Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
• Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy. Tec Automated EIA instrument. For in vitro diagnostic use only.
• Regulatory Status: Cleared by FDA on March 3, 2000, under K993557, as substantially equivalent to a legally marketed predicate device.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance metrics, one would typically need to refer to the full 510(k) submission summary or a separate study report, which is not included here.

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