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The Primus Spinal Fixation System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/ anterolateral non-pedicle 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.

The Spinal Elements Primus Spinal Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Primus or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Primus or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediative patients, the Primus and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Primus screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Spinal Elements' Primus Spinal Fixation System is comprised of a variety of screws, hooks, rods, and connectors that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). 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 screws.

Navigation instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. Instead, the document is a 510(k) premarket notification letter from the FDA regarding the "Primus Spinal Fixation System," stating its substantial equivalence to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Requirements for quality systems, reporting adverse events, and unique device identification.
• The indications for use of the Primus Spinal Fixation System.
• A 510(k) summary, including:
  • Submitter and device information.
  • Device description (screws, hooks, rods, connectors, navigation instruments).
  • Detailed indications for use.
  • Technological characteristics and comparison to a predicate device (Mercury® II Spinal System K222516).
  • Performance Data: This section only mentions mechanical testing (Static and Dynamic Compression Bending, Static Torsion, Tensile Dissociation, Neutral and Max Angle testing per ASTM standards) to demonstrate substantial equivalence to the predicate device. It explicitly states, "The subject device has the same performance characteristics as the previously cleared predicate device..." and "Testing conducted demonstrates substantial equivalence to the predicate device."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence, primarily supported by mechanical testing against established ASTM standards, not clinical performance studies with acceptance criteria as typically understood for AI/ML-driven medical devices (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

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The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit is equipped with a height-adjustable steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single-door freestanding units where the unit is accessible on all sides.

The PRIMUS Healthcare Steam Sterilizer consists of the following components and accessories:

1. Jacket Assembly (sterilizer vessel)
2. Chamber Finish
3. Chamber Door
4. Insulation
5. Chamber Drain System
6. Drain Water Quench (Piping System)
7. Vacuum system
8. Steam Source
9. Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC.

The provided document describes the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) and its non-clinical testing to demonstrate substantial equivalence to a predicate device (PRIMUS Healthcare Sterilizer, Model PSS11-HC, K221474).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify general "samples" in terms of number of devices for these tests. Instead, it states that the performance testing was conducted on "all the cycles in the PRIMUS healthcare steam sterilizer." This implies that the tests were performed on the device models (PSS11-HA and PSS11-HB) and their defined sterilization cycles as per the standards.

The document indicates "Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors." It does not provide information on the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device like a sterilizer is typically established by recognized national and international standards (e.g., ANSI/AAMI ST8, ASME codes, IEC standards) and their specified testing methodologies, rather than expert consensus on individual cases. The tests described are engineering and performance validation tests against these established standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective human assessment of diagnostic output, particularly for AI/machine learning devices. The document concerns a steam sterilizer, and the tests are objective engineering and performance validations against predefined 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

This information is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

This information is not applicable. The device is a steam sterilizer, not an algorithm, and its performance is assessed directly, not through an algorithm in a standalone capacity.

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

The ground truth for the performance of the PRIMUS Healthcare Sterilizer is based on compliance with established national and international standards. Specifically, for performance testing, it is "Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018)." Other ground truths are compliance with relevant electrical safety (UL, CSA), EMC (IEC), control panel (UL), and pressure vessel (ASME) standards.

8. The sample size for the training set

This information is not applicable. The device is a hardware sterilizer, not a machine learning or AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer is equipped with a height-adjustable, steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single door, freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Series Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.

The provided text describes the acceptance criteria and the study that proves the PRIMUS Healthcare Sterilizer (Model PSS11-HC) meets these criteria. It's important to note that this document is for a steam sterilizer, not an AI/ML medical device, so some of the requested information (like number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to AI/ML diagnostic or prognostic devices.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in the context of a test set for data (like images or patient records) as this device is a physical sterilizer. Instead, testing involves the sterilizer itself and its components.

• Sample Size: Not applicable in the traditional sense of data samples. The testing relates to the device itself and its processes.
• Data Provenance: Not applicable. The testing is based on engineering and performance validation of a manufactured device against established standards.

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

Not applicable. For a physical sterilizer, "ground truth" is established by adherence to engineering and performance standards (e.g., specific temperatures, pressures, biological indicator kill rates). There is no "expert consensus" on ground truth for diagnostic image interpretation in this context. The validation is against defined physical and biological parameters.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation tasks where human readers might disagree. For a sterilizer, the tests are objective: either the device meets the physical parameters and sterilization efficacy requirements, or it does not.

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

No. An MRMC study is relevant for diagnostic or prognostic AI/ML medical devices where human readers' performance with and without AI assistance is compared. This document concerns a physical steam sterilizer.

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

Not applicable. This is not an algorithm, but a physical device. Its "performance" is inherently "standalone" in that it performs its function (sterilization) independently, but its use requires human interaction (loading, initiating cycles, maintenance).

7. The Type of Ground Truth Used

The "ground truth" for the PRIMUS Healthcare Sterilizer is based on established industry and regulatory standards for steam sterilization. This includes:

• Physical parameters (temperature, pressure, time) according to specific cycles.
• Demonstrated sterilization efficacy (implied by compliance with standards like ANSI/AAMI ST8), which typically involves biological and chemical indicator testing.
• Compliance with electrical safety, EMC, and pressure vessel codes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set" in the machine learning sense.

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

Not applicable, as there is no training set for this device.

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The PRIMUS instrument is a non-contact, high resolution tomographic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.

The PRIMUS device is an ophthalmic instrument that provides the essential performance and functionality compared to the Carl Zeiss Meditec CIRRUS™ HD-OCT Model 4000 (K11157), with a separate manually-controlled patient interface and simplified analysis features. PRIMUS uses the same SD-OCT technology from the CIRRUS and offers a simplified user interface. In addition, the camera in the PRIMUS instrument operates at a reduced speed to acquire OCT images at comparable resolution in approximately the same amount of time.

The PRIMUS device is a computerized ophthalmologic instrument that acquires and allows visualization of cross-sectional tomograms of the eye using spectral domain optical coherence tomography (SD-OCT). The instrument is designed to scan the eye in a non-contact manner to acquire detailed cross-sectional images of various posterior ocular structures such as the retina and the optic nerve head. Various retinal structures of the eye from the internal limiting membrane to the retinal pigment epithelium (including layers such as the ganglion and retinal nerve fiber) can be imaged.

The PRIMUS instrument is available in one model, Model 200, which has a manually controlled patient interface and separate enclosure with components used in OCT scanning. The operator utilizes a keyboard, monitor and mouse to interface with the computer. Data acquired can be saved to the computer; PDFs of the reports may be saved to a USB-connected storage device.

The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [spectral domain optical coherence tomography (SD-OCT) to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal nerve fiber layers).

The device consists of two main parts: a manually controlled separate patient interface and an imaging engine box. The system is composed of a number of electrical, mechanical, and optical subsystems that are required to facilitate measurements and aid in patient alignment:

• Optical head modules
• SD-OCT engine modules
• Patient module
• Support modules

As part of its report driven workflow, at the completion of scan acquisition, PRIMUS presents the pre-ordered report(s) to the user in a sequential manner. The visualization and analysis reports that available in PRIMUS are as follows:

• Macular Thickness Analysis (MTA) Based on 512 X 32 Macular Cube Scan
• Optic Nerve Head (ONH) & Retinal Nerve Fiber Layer (RNFL) Analysis Based on 128 X 128 ONH & RNFL Cube Scan
• HD 5-line Analysis Based on 5 line HD Raster Scan
• HD 1-line Analysis Based on 1 line HD Raster Scan

The provided text describes a 510(k) summary for the PRIMUS 200 ophthalmic instrument, focusing on demonstrating its substantial equivalence to a predicate device (Cirrus HD-OCT Model 4000). The information pertains to the device's technical characteristics and performance in clinical evaluation, but it doesn't describe the acceptance criteria and performance against those criteria in a typical AI/ML medical device submission format.

However, based on the provided text, I can infer the "acceptance criteria" are implicitly demonstrating that the performance of the PRIMUS 200 is comparable to the predicate device, with mean differences and limits of agreement falling within acceptable clinical ranges, and showing good repeatability and reproducibility. The study essentially aims to prove that the PRIMUS 200 performs as well as the predicate for the specified measurements.

Here's a breakdown of the requested information based on the provided document:

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

   The document does not explicitly state acceptance criteria in a formal, quantifiable way as you might find for an AI/ML device (e.g., "accuracy > X%" or "sensitivity > Y%"). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device. This is primarily assessed by comparing the mean differences and limits of agreement between the two devices for various ocular measurements. Good repeatability and reproducibility are also considered.

   Since no specific numerical acceptance thresholds are given, the reported device performance is presented as the findings from the comparative effectiveness study:

   Implied Acceptance Criteria & Reported Device Performance for PRIMUS 200 vs. CIRRUS 4000

   Metric	Implied Acceptance Criterion (relative to predicate)	Reported Device Performance (Mean Differences, PRIMUS 200 - CIRRUS 4000)
   Comparative Analysis	Mean differences and 95% Limits of Agreement should demonstrate substantial equivalence (i.e., differences are clinically acceptable and comparable to predicate).	Normal Eyes (N=45):

• Macular Thickness: Mean differences range from -4.8 µm (Outer Inferior) to +0.1 µm (Central Subfield).
• RNFL Thickness: Mean differences range from -2.8 µm (Inferior) to -1.2 µm (Temporal).
• ONH Parameters: Mean differences range from -0.02 mm² (Rim Area, Disc Area) to +0.01 (Average Cup-to-Disc Ratio, Vertical Cup-to-Disc Ratio).
  Retinal Disease Eyes (N=39):
• Macular Thickness: Mean differences range from -6.2 µm (Outer Inferior) to +1.8 µm (Central Subfield).
  Glaucomatous Eyes (N=43):
• RNFL Thickness: Mean differences range from -3.0 µm (Nasal) to +1.2 µm (Temporal).
• ONH Parameters: Mean differences range from 0.00 (Rim Area, Average Cup-to-Disc Ratio, Vertical Cup-to-Disc Ratio) to 0.02 mm² (Disc Area).
  The studies conclude that the mean values of the 19 thickness parameters were very similar between the two devices, demonstrating substantial equivalence. |
  | Repeatability and Reproducibility | Measurements should show good repeatability and reproducibility. | Normal Eyes (N=44):
• Repeatability SDs: Macular thickness parameters (0.90% to 1.76% COV), RNFL thickness parameters (2.12% to 5.01% COV), ONH parameters (1.844% to 6.702% COV).
• Reproducibility SDs: Macular thickness parameters (1.67% to 2.26% COV), RNFL thickness parameters (2.76% to 5.72% COV), ONH parameters (2.397% to 7.660% COV).
  Diseased Eyes (N=38 for Macular, N=43 for RNFL/ONH):
• Repeatability SDs: Macular thickness parameters (1.14% to 4.02% COV), RNFL thickness parameters (3.02% to 6.10% COV), ONH parameters (1.829% to 8.645% COV).
• Reproducibility SDs: Macular thickness parameters (1.59% to 4.52% COV), RNFL thickness parameters (3.89% to 8.36% COV), ONH parameters (2.091% to 8.814% COV).
  The studies conclude that PRIMUS 200 showed good repeatability and reproducibility for both normal and diseased eyes. |

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

   • Comparative Analysis:
     • Sample Size: 127 subjects (45 normal, 39 retinal disease, 43 glaucoma subjects).
     • Data Provenance: The study was a "prospective study." The country of origin of the data is not specified in the provided text.
   • Repeatability and Reproducibility Study:
     • Sample Size: 125 subjects (44 normal, 38 retinal disease, 43 glaucoma subjects).
     • Data Provenance: Not explicitly stated as retrospective or prospective for this specific study, but it follows the comparative analysis which was prospective. Country of origin not specified.

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 is not an AI/ML device where expert-labeled ground truth for images is typically established. This is a medical device designed for making objective measurements (thickness, area, ratios). The "ground truth" for the comparative analysis is the measurements obtained from the predicate device (Cirrus HD-OCT Model 4000), which is a legally marketed device. The study aims to show that the PRIMUS 200 produces measurements comparable to this established predicate. Experts are involved in operating the devices and potentially interpreting the results, but they are not establishing a subjective "ground truth" for each case in the same way as an image interpretation task.

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

   Not applicable. This is not a study assessing diagnostic performance based on subjective interpretations or needing adjudication of disagreeing expert opinions. The study compares quantitative measurements obtained by two different devices.

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 not an AI/ML device that assists human readers. It is an imaging device that produces quantitative measurements. The study is a direct comparison of measurements between the proposed device and a predicate device.

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

   Yes, in the sense that the device itself performs the measurements. The "algorithm" here is the device's inherent measurement capability. The clinical evaluation directly compares the measurements generated by the PRIMUS 200 (device only with human operation) to those generated by the predicate device (also device only with human operation). It's a device-to-device comparison for quantitative outputs.

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

   The "ground truth" is established by the measurements from the predicate device, the Carl Zeiss Meditec CIRRUS™ HD-OCT Model 4000 (K111157), which is an already cleared device for similar indications. The study's purpose is to demonstrate that the PRIMUS 200 produces measurements that are substantially equivalent to this established device.

8. The sample size for the training set

   Not applicable. This device is not described as an AI/ML device that requires a training set in the conventional sense. Its functionality is based on established optical coherence tomography (OCT) technology and software for measurement rather than a machine learning model trained on a dataset.

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

   Not applicable, as there is no mention of a machine learning training set or associated ground truth.

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Primus Hearing Instrument Test Unit (PHITU):
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.

• The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved.

Primus Fitting Unit (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.

• The Primus Fitting Unit is intended for hearing test.
• The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments.
• The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
• Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
• The Primus Fitting Unit is indicated for use with both pediatric and adult age groups.
• The Primus Fitting Unit is not indicated as a sole means of diagnostics.

The Primus Fitting System is a PC operated system that contains Primus Hearing Instrument Test unit (PHITU) for Hearing Instrument testing (HIT), Primus Fitting Unit (PFU) for Audiometry (AUD) and Real Ear measurement (REM). The Primus Fitting System is operated from a dedicated software application installed on a standard Windows operating system. The Primus Fitting system can either be sold individually (PHITU or PFU) or together (PHITU and PFU).
The Primus software solution operates within the NOAH framework, as well as stand-alone. On-top diagrams and control panels make it easy to use simultaneously with the proprietary hearing instrument fitting systems of your choice. The stand-alone client data files hold all historical session information, and makes fittings away from the office very easy.

Audiometry (AUD):
Primus AUD is a PC based audiometry module providing a wide range of possibilities within pure tone audiometry, bone conduction audiometry and speech audiometry including inserts probe and industry standard headsets with an option of high frequency testing.

Real Ear Measurements (REM):
Primus REM offers classic Real Ear Measurements as well as comprehensive Speech Mapping measurements, where all measurements include high frequency testing. The measurements are supported by a large sound library including technical sounds, daily life sounds, speech signals and dialogue. The Primus REM module contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear.
The classic Real Ear Measurements, which can be performed by Primus REM, include: Unaided, Occluded and Aided Response as well as Insertion Gain. Toggling between SPL and Gain shows the response measurements in gain view.
The PFU hardware is powered by a USB connection from the PC and a medical grade power supply (for extended sound pressure) and can be placed at the most convenient working place.

Hearing Instrument Testing (HIT):
Primus HIT offers full featured technical measurements for testing and troubleshooting hearing instruments. The test can be run as an automatic test sequence in accordance with European and American standards. The Primus HIT unit module contains of 2 microphones (one for measuring and one for reference) and various couplers for hearing aid testing.
The PHITU hardware is powered by a USB connection from the PC and can be placed at the most convenient working place.

The submission describes the Auditdata Primus Fitting System, which consists of the Primus Hearing Instrument Test Unit (PHITU) and the Primus Fitting Unit (PFU). The device is intended for professionals to perform hearing instrument testing, audiometry, and real ear measurements.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards. The reported "performance" is implicitly achieving compliance with these standards.

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

The submission explicitly states that "non-clinical performance testing" was conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily device-centric, focusing on the functionality and measurement accuracy of the Primus Fitting System itself against established technical standards, rather than patient- or human-subject data.

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

The document does not mention the involvement of experts to establish a "ground truth" for a test set in the context of diagnostic accuracy or clinical decision-making. The testing described focuses on the technical performance of the device against industry standards, where the "ground truth" is typically defined by the precise measurement requirements and specifications within those standards.

4. Adjudication Method for the Test Set:

Given that there is no mention of a human-interpreted test set or diagnostic accuracy evaluation, there is no information provided on an adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The device is a measurement and testing system, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The studies described are standalone performance evaluations of the device itself (PHITU and PFU). The tests assess the accuracy and compliance of the device's measurements and functionalities according to established technical standards (e.g., ANSI, IEC). The device operates as an instrument, and its performance is evaluated based on its ability to accurately perform those instrumental functions.

7. Type of Ground Truth Used:

The ground truth used for the testing is primarily the specifications and requirements defined within the referenced industry standards (e.g., ANSI S3.6, ANSI S3.22, ANSI S3.46, IEC 60118-7, EN 61669). The "ground truth" for this type of device, which measures acoustic properties and performs audiometry, is the accurate and precise adherence to these technical benchmarks. It does not involve expert consensus on medical conditions, pathology results, or clinical outcomes data in the typical sense of a diagnostic AI device.

8. Sample Size for the Training Set:

The submission does not mention a "training set" as the device is not described as utilizing machine learning or artificial intelligence in a way that would require a distinct training phase. Its operation is based on conventional electronic circuit design, digital signal processing, and software logic.

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

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

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The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Ablative Laser Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, dyschromia and pigmented lesions.

he 1440 and 2940 Fractional combined treatment is intended for dermatological procedures quiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin surfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, schromia and pigmented lesions.

The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local culation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.

This document is a 510(k) summary for the Palomar Icon™ Aesthetic System, indicating substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics or detailed study results proving the device meets such criteria. Instead, it relies on the assertion of "substantial equivalence" to previously cleared devices.

Therefore, most of the requested information cannot be extracted from this document, as it outlines the regulatory submission, intended uses, and device description, rather than clinical performance data against pre-defined acceptance criteria.

Here's an attempt to answer what can be gathered, with clear indications where information is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not available in this document. The submission relies on "performance data" but does not detail studies with specific sample sizes for a 'test set'.
• Data Provenance: Not available in this document. The document mainly discusses regulatory equivalence and does not specify the country of origin of any data, nor whether it was retrospective or prospective.

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

• Number of Experts: Not applicable/Not available. This document does not describe the establishment of ground truth by experts for a test set, as no specific clinical performance study is detailed against newly established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not available. No specific test set performance study or adjudication process is described.

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

• MRMC Study Done: No, based on the information provided. The document does not describe any MRMC study or the effect size of human readers with vs. without AI assistance. The device is a laser/light system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: Not applicable/Not available. This device is a physical system (laser/light handpieces) for aesthetic and surgical procedures, not an algorithm. Therefore, "standalone algorithm performance" is not relevant in this context.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not available in the context of a performance study against specific ground truth. The submission relies on the concept of "substantial equivalence" to predicate devices, meaning its safety and effectiveness are deemed similar to devices already on the market and legally used. No new ground truth establishment is described for proving efficacy of the Icon system itself as a novel device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not available. This document pertains to a physical medical device, not an AI/ML algorithm that would typically involve a "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable/Not available. As above, this document does not describe an AI/ML algorithm that uses a training set with established ground truth.

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The PRIMUS PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterliization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens.

The PRIMUS PSS8 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 and K082817. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers: offered in either horizontal or vertical sliding door applications. The PSS8-J, K and M units may be pit-mounted, allowing the optional floor carts to roll directly in to the chamber. All sterilizer doors are designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available. PSS sterilizer units offered under this request for clearance are available in the following configurations: PSS8-AA-M, PSS8-A-M, PSS8-B-M, PSS8-C-M, PSS8-D-M, PSS8-E-M, PSS8-F-M, PSS8-G-M, PSS8-G.1-M, PSS8-J-M, PSS8-K-M, PSS8-M-M. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration.

This document describes the validation of the PRIMUS PSS8 Steam Sterilizers, a Class II medical device, against established safety and effectiveness standards.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PRIMUS PSS8 Steam Sterilizers are derived from FDA-recognized consensus standards for electrical safety and steam sterilization effectiveness. The reported device performance indicates conformance to these standards.

• AAMI / ANSI / IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment -- Part 1-2: Collateral Standard - General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests.
• UL 61010A-1, IEC 61010-1 Amendment 2, and the Part 2, Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials & for Laboratory Process, IEC 61010-2-041, UL 61010A-2-041.
• CAN/CSA-C22.2 No. 1010 and CAN/CSA-C22.2 No. 1010.2-041-96 (Canadian Standard for Laboratory Equipment). | PRIMUS declares conformance to all listed electrical safety standards and applicable industry and electrical codes. Software-designed fail-safe controls provide appropriate warnings and signals. Safety warnings and signals are challenged and verified during a 100% Factory Acceptance Test, with results documented in the Device History Record (DHR). |
  | Sterilization Effectiveness | Validation against ANSI/AAMI ST8:2001, Hospital steam sterilizers, ensuring that the sterilizer achieves a Sterility Assurance Level (SAL) of $10^{-6}$ for each load cycle type. The standard establishes minimum construction and performance requirements for hospital sterilizers using saturated steam for volumes greater than 2 cubic feet (56 liters) with no exclusions. | PRIMUS has validated sterilizer performance for each load cycle type. Internal validation protocols comply with ANSI/AAMI ST8:2001. Product performance data was independently validated with Biological Indicators (BIs) exposed during validation for each cycle type. Data output from the validation report met a Sterility Assurance Level (SAL) of $10^{-6}$ when the sterilizer is used and maintained as directed. |
  | Pressure Vessel Safety | Design, manufacture, and testing in accordance with American Society of Mechanical Engineers (ASME), Section VIII, Division 1 Unfired Pressure Vessels. | PRIMUS PSS8 Pressure Vessels are designed, manufactured, and tested in accordance with ASME, Section VIII, Division 1 Unfired Pressure Vessels. |
  | User Information | Provision of information in the User's Manual to ensure safe and effective use. Recommendation for periodic monitoring of sterilizer performance in accordance with ANSI/AAMI ST79:2006. | PRIMUS provides information in the User's Manual. PRIMUS recommends that a suitable chemical indicator or biological challenge test be used periodically according to health care facilities' documented plan for monitoring SAL $10^{-6}$ performance. PRIMUS also recommends using validated factory preset cycles as per ANSI/AAMI ST79:2006. |

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

The document does not explicitly state a "test set" in the context of a dataset for an AI/algorithm, as the device is a steam sterilizer. Instead, the validation involved testing the sterilizer's performance with various load types and configurations for all models.

• Sample Size: The sample size for effectiveness testing is implied by the range of sterilizer models and load configurations tested. The table details testing for 12 different sterilizer models (e.g., PSS8-AA-M, PSS8-K-M) across 6 different cycle types (Vacuum, Gravity, Liquids, Test (VAC)) and varying load configurations (e.g., "Unwrapped Nonporous Single Instrument," "Double wrapped instrument trays 16 pounds each tray," "Textile packs 9x9x6, 12 lbs.," "Vented borosilicate glass containers"). Each cycle type and load configuration combination for each sterilizer model represents an individual test scenario. While the exact number of individual runs for each scenario is not provided, the validation covered a comprehensive range of operating conditions.
• Data Provenance: The study was conducted internally by PRIMUS Sterilizer Company, LLC. The data is prospective, generated through systematic testing and validation protocols to ensure compliance with recognized standards. The country of origin of the data is not explicitly stated but is implicitly the United States, given the company's location (Omaha, NE), the regulatory body (FDA), and the standards referenced (AAMI/ANSI, UL, ASME).

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

This information is not applicable. The device is a steam sterilizer, not an AI/algorithm that requires interpretation by human experts to establish ground truth for a test set. The efficacy of sterilization is objectively measured using biological indicators (BIs) to demonstrate a Sterility Assurance Level (SAL), which serves as the "ground truth" for sterilization effectiveness.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a steam sterilizer. The "test set" in this context refers to the physical sterilization tests conducted, and the results are objectively measured (e.g., viability of biological indicators), not subject to human adjudication for discrepancies.

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. The PRIMUS PSS8 Steam Sterilizers are physical medical devices designed for sterilization, not AI-powered diagnostic or assistive tools that would involve human readers or MRMC studies.

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

This information is not applicable as the device is a steam sterilizer. While the sterilizer does contain "validated software" for fail-safe controls, this software operates as an integral part of the mechanical and thermal system, not as a standalone AI algorithm whose performance is evaluated independently in comparison to human performance.

7. The Type of Ground Truth Used

The ground truth used for effectiveness validation was the Sterility Assurance Level (SAL) of $10^{-6}$, as measured by biological indicators (BIs).

• Biological Indicators (BIs): These contain a known number of highly resistant bacterial spores. After a sterilization cycle, the BIs are incubated, and their viability (or lack thereof) indicates whether the sterilization process was successful in killing all microorganisms, achieving the specified SAL.
• Conformance to ANSI/AAMI ST8:2001: This standard defines the performance criteria for hospital steam sterilizers, including the acceptable SAL.

8. The Sample Size for the Training Set

This information is not applicable in the context of typical AI/ML training sets. While there is a "validated software" designed into the sterilizers, it is not described as an AI or machine learning model that undergoes a "training" phase with a dataset in the conventional sense. The software's reliability and functionality are likely established through rigorous software validation and verification processes according to industry standards, rather than statistical training on a large dataset.

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

This information is not applicable for the same reasons mentioned in point 8. The "ground truth" for the software refers to its ability to correctly execute control functions, provide accurate readings, and trigger appropriate warnings/signals in various operational and malfunction scenarios. This is established through software testing, simulation, and hardware-in-the-loop testing, not through a "training set" of data with pre-established ground truth labels as would be used for AI/ML models.

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The PRIMUS PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard linens.

The PRIMUS PSS5 Steam Sterilizers (or Autoclaves) are Class II, Product Code FLE Medical Devices as defined by CFRS880.6880 and defined for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilize Series provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The models contained within this submission request utilize the same technology, materials and updated software as predicate devices cleared under K991575 except for larger chamber sizes. The proposed PRIMUS Steam Sterilizer chambers offered within this submission is equipped with the same options offered under the predicate device, in design and construction except for ASME approved (optional) carbon steel reinforced doors, the vessel size and (optional 304 stainless) vessel jackets configured with 316L internal surface stainless steel chambers; offered in either horizontal or vertical sliding door applications. The PSS-M unit may be pit-mounted, allowing the optional floor cars to roll directly in to the chamber. All large sized sterilizers have pneumatically powered horizontal operating doors, designed to be efficient, reliable and inherently safe. Pass through (double-door) models are also available. PSS sterilizer units offered under this request for clearance are available in Multi-function or Laboratory/Lo configurations. The Multifunction units also offer vacuum, gravity, liquids and test (VAC) configuration, whereas the Laboratory/Lo units offer vacuum, gravity, and low operating temperature configuration.

The provided text describes the PRIMUS PSS5 Steam Sterilizers and includes information related to its safety and effectiveness. However, it does not contain the specific type of acceptance criteria or a study design in the format requested for a medical AI/ML device (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, training/test set sizes for AI models, expert qualifications for ground truth, etc.).

The document is a 510(k) summary for a steam sterilizer, which is a physical medical device, not a software or AI/ML-based diagnostic or prognostic tool. Therefore, the questions related to AI/ML device evaluation metrics and study design cannot be fully answered from the provided text.

Here's an attempt to extract relevant information given the context of the document:

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

Since this is a physical sterilizer and not an AI/ML device, the acceptance criteria are not in terms of traditional diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to sterilization efficacy and safety compliance with recognized standards.

The study that proves the device meets these criteria is an internal validation conducted by PRIMUS, which involved exposing biological indicators and reviewing data output to confirm the SAL of 10⁻⁶. This validation adheres to the ANSI/AAMI ST8:2001 standard.

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

This information is not provided in the document. The validation mentions "I indicators were exposed during validation for each cycle type," but the specific number (sample size) of indicators or the methodology of the test set is not detailed. The provenance (country of origin, retrospective/prospective) is also not stated.

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 relevant or provided for a steam sterilizer. Ground truth for sterilization efficacy is established through scientific principles and validated biological indicators, not typically by human experts reviewing visual or diagnostic data.

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

Not applicable to this type of device and 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

Not applicable, as this is not an AI/ML diagnostic device with human readers.

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

Not applicable, as this is a physical medical device. The "algorithm" refers to the sterilizer's controlled cycles, which operate autonomously once initiated by a human. Its performance is evaluated on its own ability to sterilize.

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

The ground truth for the effectiveness of the sterilizer is a Sterility Assurance Level (SAL) of 10⁻⁶, which is a widely accepted scientific standard for terminal sterilization. This is typically established through the use of biological indicators (e.g., spores of highly resistant microorganisms) which, after exposure to the sterilization cycle, are cultured to determine if any viable organisms remain. This is a scientific and objective measure rather than expert consensus or pathology in the diagnostic sense.

8. The sample size for the training set

Not applicable. Steam sterilizers do not use "training sets" in the AI/ML sense. Their operational parameters are determined through engineering design, scientific principles of sterilization, and validation studies.

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

Not applicable for a physical sterilizer. The operational parameters (temperature, time, pressure, vacuum cycles) are established based on scientific understanding of microbial inactivation kinetics and validated against industry standards (e.g., ANSI/AAMI ST8:2001) to achieve the desired SAL.

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The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".

The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.

The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

• "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."

However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

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The Primus A1care Assay A1c test, for use with the TRI•stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

The Primus TRI•stat™ Instrument is a small (10"Wx11"Lx4"H), in vitro diagnostic instrument used with the Primus A1care Assay test to quantitate HbA1c using a patented two-phase optical method. The TRI•stat™ is capable of analyzing a total of 3 samples simultaneously.

The provided document is a 510(k) summary for the Primus TRI•stat™ Instrument and A1Care Assay, indicating substantial equivalence to a predicate device (K891235, Primus Boronate Affinity HPLC Method). However, it does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a comprehensive study report.

The document primarily focuses on establishing equivalent intended use, technology, and performance to the predicate device. It states: "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrate that the instrument and test substantially equivalent to the predicate device and are safe and effective for their intended use."

Without the actual study reports, the following information cannot be extracted:

Here's a table based on the information not available in the provided document, indicating what would typically be requested for such a description:

Acceptance Criteria and Device Performance (Not Provided in Document)

Here's a breakdown of the other requested information, indicating what is available and what is not:

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

   • Sample Size (Test Set): Not specified in the provided document. The document only mentions "comprehensive studies."
   • Data Provenance: Not specified.
   • Retrospective or Prospective: Not specified.

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

   • Not applicable as the device measures a quantitative biomarker (HbA1c). Ground truth for such devices is typically established through reference methods or certified reference materials, not expert consensus in the diagnostic imaging sense. The document implies comparison to the predicate device (Primus Boronate Affinity HPLC Method) and "known standards."

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

   • Not applicable for a quantitative diagnostic assay. Performance is assessed by statistical comparison to a reference method or certified values.

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

   • Not applicable. This is a standalone in-vitro diagnostic instrument for measuring a biomarker, not an AI-assisted diagnostic imaging device that involves human readers.

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

   • The document describes the TRI•stat™ Instrument and A1Care Assay as standalone in-vitro diagnostic device. It quantifies HbA1c using a "patented two-phase optical method." While the instrument is "Partially Automated" and "Requires Sample Insertion and Tube Insertion," the measurement and result generation appear to be fully automated once the sample is loaded. Therefore, performance evaluation would be standalone. The document states "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies."

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

   • The document implies that performance is benchmarked against "known standards" and the predicate device (Primus Boronate Affinity HPLC Method). For HbA1c measurements, ground truth would typically be established by:
     • Reference methods: Such as HPLC methods (like the predicate device) or methods traceable to IFCC reference systems.
     • Certified reference materials: Samples with known, validated HbA1c concentrations.

7. The sample size for the training set

   • Not specified. The document does not describe the development or training of any machine learning model, only the evaluation of the full device. It mentions "factory calibrated" for optical measurements, which implies internal calibration data but not a distinct "training set" in the context of machine learning.

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

   • Not applicable as no specific "training set" for a machine learning model is mentioned. Calibration and performance are likely based on reference materials and comparisons to established methods.

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