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The intended use of the Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

The intended use of the EPIQ, EPIQ 7 is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Cardiac. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel.

Philip Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices which are intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.

Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' Diagnostic Ultrasound Systems.

Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips Diagnostic Ultrasound Systems and QLAB software and may vary among model configurations.

The diagnostic ultrasound systems are manufactured with hardware components which consist of:

• a primary console (e.g., workstation, tablet) with built-in software components, features, and 1) various clinical applications, and
• 2. a range of compatible ultrasound transducers.

A suite of compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array, linear array and sector/ohased array transducer models which have a prefix "C" are designed to provide larger fields of view and penetration for e.g., consolidation between bone spaces while linear array transducer models, which can be identified with a "L" prefix model name are designed to provide shallow visualization which are optimal for tissue layer interfaces. Sector/phased array transducer models which usually have a "S" prefix model names are designed to be applied for difficult anatomical sites (e.g., cardiac intercostal space (ICS)). Other Philips ultrasound transducers may also start with the prefix "X" which is referring to the xMatrix technology for two full-resolution planes of imaging. Volumetric three-dimensional (3D) imaging functionality is also available when specific transducer models are connected to the primary console. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

This document is a 510(k) Premarket Notification from Philips Ultrasound, Inc. to the FDA regarding several of their diagnostic ultrasound systems and software. The primary purpose of this submission is not to present performance data for a new device that meets acceptance criteria, but rather to assert substantial equivalence to previously cleared predicate devices for expanded labeling related to COVID-19.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, does not apply in the traditional sense for a new device submission with novel performance claims.

Instead, the submission states:

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

• There is no specific table of acceptance criteria or reported device performance for novel features in this submission.
• The document focuses on establishing technological characteristic equivalence between the subject devices and their respective predicate devices.
• Table 1, Table 2, Table 3, Table 4, Table 5, and Table 6 (spanning pages 13-25) provide a technological comparison for each subject device (Philips Lumify, EPIQ, Affiniti, CX50, Sparq, and QLAB software) against its predicate device. For all listed "Standard Features" (Indications for Use, Reusable?, Duration of Use, Scientific Technology, Operating principles, Type of Previously-cleared Transducers, Acoustic Outputs Within Range?, Previously cleared Imaging Modes?, Biocompatibility), the comparison consistently states "Identical." This indicates that no new performance metrics or acceptance criteria beyond those already established for the predicate devices are being introduced for new functionalities.

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

• Not applicable. The submission does not describe a new performance study requiring a test set. It relies on the equivalence of the subject devices to their predicate devices, which would have undergone performance testing for their initial clearances.

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

• Not applicable. No new ground truth establishment is described in this submission.

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

• Not applicable. No new performance study or test set requiring adjudication is described.

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. No MRMC study is mentioned. The submission is for existing ultrasound systems and software with expanded labeling, not for AI-assisted diagnostic tools requiring such studies for comparative effectiveness.

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

• Not applicable. While QLAB is software, the submission primarily focuses on maintaining substantial equivalence in its current functionality and expanding labeling. No new standalone algorithm performance is detailed.

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

• Not applicable. No new ground truth is described. The established safety and effectiveness of the predicate devices implicitly relied on various forms of ground truth relevant to diagnostic ultrasound at the time of their clearance.

8. The sample size for the training set:

• Not applicable. This submission does not involve a new machine learning algorithm or a training set.

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

• Not applicable. This submission does not involve a new machine learning algorithm or a training set.

Summary of the Submission's Approach:

The core of this 510(k) submission is to assert that the subject devices (various Philips Diagnostic Ultrasound Systems and QLAB software) are substantially equivalent to their respective predicate devices. The significant change being addressed is the "Expanded Labeling" to include information about lung and cardiac ultrasound imaging for COVID-19 patients, based on established methods or the latest society guidelines. The submission explicitly states:

• "Relevant performance data does not apply to this submission." (Page 26)
• "There are no changes in software, hardware, and intended uses of the subject devices comparing to the predicates." (Page 26)
• "The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices." (Page 26)

Therefore, the "study" proving the device meets "acceptance criteria" is essentially the argument of identical technological characteristics and unchanged intended uses compared to the already cleared predicate devices, with the new labeling information being based on general clinical practice and guidelines rather than new device-specific performance data.

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Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel. The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application. The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips CX50 and Sparq Diagnostic Ultrasound Systems are implicitly defined by compliance with several international and FDA-recognized consensus standards, as well as the FDA's specific guidance for diagnostic ultrasound systems. The reported device performance is that it complies with these standards and guidances, and meets the acceptance criteria.

• Indication for use
• Technological characteristics
• Non-clinical performance testing
• Safety and effectiveness
  These devices share the same gray-scale and Doppler capabilities, fundamentally identical scientific technology, same materials (bio-safety), equivalent quality systems, and same electrical and physical safety standards. | This is the primary conclusion of the submission, based on the non-clinical testing, confirming that the device meets the acceptance criteria for substantial equivalence to the predicate devices. |

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

The document explicitly states: "The modified CX50 and Sparq Diagnostic Ultrasound Systems did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System and reference predicate EPIQ Diagnostic Ultrasound System was demonstrated with the following attributes: • Indication for use; • Technological characteristics; • Non-clinical performance testing; and • Safety and effectiveness." (Page 39)

Therefore, there appears to be no separate clinical test set in the traditional sense for evaluating the performance of the modified device against specific clinical metrics. Instead, the performance was established through non-clinical testing and comparison to legally marketed predicate devices.

The data provenance for the modifications is based on the previously cleared predicate device (CX50, K123754) and reference device (EPIQ/Affiniti, K160807), which would have undergone their own testing. The current submission relies on the established safety and effectiveness of these predicates.

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

Since no clinical test set was required for the modified device, there's no information provided about experts establishing ground truth for a test set. The evaluation was primarily non-clinical and comparative.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with human interpretation was conducted for this specific 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No MRMC comparative effectiveness study was mentioned or indicated as being performed for this submission. The submission explicitly states "did not require clinical data."

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

This refers to a diagnostic ultrasound system, which is a hardware device with software, not typically a standalone algorithm like AI software. The performance assessment was based on the system's ability to acquire and display ultrasound data in various modes, complying with established physical and safety standards. Therefore, an "algorithm only" standalone performance study in the context of an AI-driven system is not applicable here.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by the engineering and quality control standards defined in the referenced IEC and ISO standards. This includes:

• Engineering specifications and measurements for acoustic output (e.g., ISPTA, MI, TI).
• Compliance with electrical and physical safety requirements.
• Biocompatibility testing against ISO 10993 standards for materials.
• Verification and validation against system requirements and risk controls.

The ground truth for the predicate devices (K123754 and K160807) would have involved comprehensive testing for their initial clearances, which may have included a combination of phantom studies, animal studies, and potentially clinical studies to establish their diagnostic capabilities. However, this submission specifically highlights that additional clinical data was not required due to the substantial equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The system's functionalities are based on established ultrasound physics and engineering principles, not statistical learning from data.

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

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

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The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical --mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)

The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.

The Philips CX50 Diagnostic Ultrasound System received clearance for additional indications for Cardiac Pediatric and Neonatal Cephalic applications. This was a 510(k) Premarket Notification based on substantial equivalence to predicate devices (Philips HD11 Diagnostic Ultrasound System, K043535 and earlier CX50 submissions K091804 and K081802). The submission states that no new features or technical characteristics were introduced.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution) for the new indications. Instead, the "acceptance criteria" for this 510(k) largely revolve around demonstrating substantial equivalence to previously cleared devices for these specific indications and confirming that no new safety or effectiveness concerns arise.

The "device performance" reported is that the CX50 system, with the additional indications, is substantially equivalent in safety and effectiveness to its predicate devices.

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

No specific test set or clinical study data is provided for the new indications with the CX50. The submission explicitly states: "No new testing was required to determine safety and efficacy of the CX50 with the new indications."

Safety and effectiveness were demonstrated through substantial equivalence to existing predicate devices already cleared for these applications, and through previous submissions for the CX50 system itself. Therefore, there is no explicit "sample size used for the test set" or direct "data provenance" for this 510(k) submission regarding the new indications. The reliance is on prior clearances.

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

Since no new clinical testing was performed for this specific 510(k) for the new indications, there is no mention of "experts used to establish ground truth for the test set." The substantial equivalence argument relies on the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set

As no specific test set or clinical study was conducted for the new indications in this submission, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was conducted or referenced in this submission. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation software.

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

This submission is for a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It is not an "algorithm only" device, and therefore, no standalone algorithmic performance study was conducted.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given that no new clinical study was performed for the new indications, no specific "type of ground truth" was established or used for this submission pertaining to the new indications. The ground truth for the clinical safety and effectiveness of the predicate ultrasound systems would have been established through methodologies typical for medical device approvals at their time, likely involving assessments by qualified medical professionals (e.g., radiologists, cardiologists) correlating ultrasound findings with patient presentation, other diagnostic tests, or clinical outcomes.

8. The Sample Size for the Training Set

No training set is mentioned as part of this 510(k) submission, as it relates to the addition of new indications to an existing ultrasound system. The device itself is not a machine learning or AI-driven algorithm that would typically require a training set for its core functionality.

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

Since no training set is mentioned in this submission, there is no information on how its ground truth would have been established.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetric, Abdominal, Intra-operative (vascular/epicardial), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Intra-luminal, Musculo-skel (conventional), Musculo-skel (superficial), Other (Gynecological), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Other (Fetal), Peripheral vessel, Other (Specify).

The CX50 is a compact diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers.

The provided text describes a 510(k) premarket notification for the Philips CX50 Diagnostic Ultrasound System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies with specific acceptance criteria and performance metrics against a ground truth.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this 510(k) submission.

The core of this submission is to show that the CX50 system is as safe and effective as existing, cleared ultrasound systems without presenting primary performance data against predefined acceptance criteria.

Here's why the requested information is absent and why this submission works differently:

• Substantial Equivalence (510(k) pathway): The FDA's 510(k) pathway for medical device clearance is based on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness and is as safe and effective as the predicate.
• No New Clinical Studies Required: In most 510(k) submissions, new clinical performance studies are not required to establish safety and effectiveness. Instead, the focus is on comparing the new device's specifications, technological features, and indications for use to those of the predicate device(s).
• Focus on Comparison, Not Absolute Performance: The document predominantly compares the CX50 to existing Philips HD11 and General Electric Vivid-i ultrasound systems, highlighting similarities in:
  • Intended use (diagnostic ultrasound imaging and fluid flow analysis).
  • Gray-scale and Doppler capabilities.
  • Imaging, Doppler, and signal processing technologies.
  • Acoustic output limits (below Track 3 FDA limits).
  • Manufacturing quality systems and biosafety of materials.
  • Electrical and physical safety standards.

In summary, there is no study described in this document that proves the device meets specific acceptance criteria in the way one might expect for a de novo or PMA submission. The "proof" here is the argument for substantial equivalence to already cleared devices.

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