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The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), 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, Lung, Ophthalmic.

The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems.

The Lumify Diagnostic Ultrasound System (iOS) utilizes:

1. A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet)
2. The Philips Ultrasound Lumify software running as a medical device application on the COTS device
3. The Philips C5-2 Curved array USB transducer
4. The Philips L12-4 Linear array USB transducer
5. The Philips S4-1 Sector array USB transducer
6. Lumify Micro B Transducer Cable
7. Lumify Micro C Transducer Cable
8. Lumify USB-C to USB-C Transducer Cable
9. Lumify Power Module

The purpose of this Traditional 510k pre-market notification is to add Ocular preset to currently commercialized L12-4 transducer available with Lumify Diagnostic Ultrasound System. Addition of Ocular preset will be available under newly added Ophthalmic clinical indication, as part of this 510k submission.

The Ocular Preset is an imaging setting to image the eye. It supports 2D (B Mode) and Color Doppler Mode and is available under "Ophthalmic" clinical indication.

The ocular preset is available to download with the Lumify 5.1 software and is available with the previously commercialized L12-4 Lumify transducer.

Based on the provided FDA 510(k) clearance letter for the Philips Lumify Diagnostic Ultrasound System (K242670), here's an analysis regarding acceptance criteria and the study that proves the device meets them:

It's crucial to understand that this 510(k) application is for an addition of an "Ocular preset" to an already cleared device (Lumify Diagnostic Ultrasound System, K192226), utilizing an already cleared transducer (L12-4). The core technology and device itself are established. Therefore, the "study" described focuses on validating the new Ocular preset and Ophthalmic indication against existing standards and a reference device, rather than a full de novo clinical trial for a completely new device.

Key takeaway: The document explicitly states, "The proposed Lumify Diagnostic Ultrasound System with Ocular preset did not require clinical data for determination of substantial equivalence" and "For testing, all pre-determined acceptance criteria were met." This suggests the acceptance criteria were primarily met through non-clinical performance testing and substantial equivalence arguments based on technical similarity to a predicate and reference device that already had the Ophthalmic indication.

Acceptance Criteria and Device Performance

Since no specific quantitative acceptance criteria or clinical study results are detailed in the provided document (as it was deemed unnecessary for this 510(k)), we infer the acceptance criteria from the information presented:

Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on the supplied document)

Given that the submission category is a "Traditional 510(k)" for an addition to an already cleared device, and not a de novo submission or one requiring extensive clinical data, the "study" primarily consists of non-clinical performance testing and a technological comparison to establish substantial equivalence.

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

   • Test Set Sample Size: Not explicitly stated as a number of cases or images. The testing conducted was "non-clinical verification testing" to address system-level requirements, design specifications, and risk control measures. This implies testing against engineering specifications and possibly phantom studies rather than a clinical dataset of patients.
   • Data Provenance: Not applicable in the context of a clinical test set from patients. The testing was internal to Philips Ultrasound, conducted according to their internal procedures.

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

   • This information is not provided as no clinical test set requiring expert ground truth establishment was deemed necessary for this 510(k) submission. The substantial equivalence argument relies on the prior clearance of the predicate and reference devices for similar indications.

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

   • None is explicitly described. As no clinical test set was required for human review with an established ground truth, adjudication methods are not applicable here.

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

   • No MRMC study was done. This 510(k) is for a diagnostic ultrasound system and its imaging preset, not an AI/CADe/CADx device that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.

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

   • Not applicable. This is a diagnostic imaging system, not an algorithm. Its performance is inherent to its ability to acquire and display ultrasound data.

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

   • For the non-clinical performance testing, the "ground truth" would be the engineering and performance specifications the device was designed to meet. For the substantial equivalence argument, the effective "ground truth" is the demonstrated safe and effective performance of the predicate and reference devices for similar imaging capabilities. No clinical ground truth (e.g., pathology, outcomes) was required for this specific 510(k) submission.

7. The sample size for the training set:

   • Not applicable. This is a traditional diagnostic ultrasound system, not an AI/machine learning product that requires a "training set" in the conventional sense. The "training" of the system refers to its design and engineering to meet diagnostic imaging requirements.

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

   • Not applicable, as there is no "training set" in the machine learning context for this device. Ground truth for the underlying ultrasound technology would be established through physics principles, engineering design, and prior clinical validation of similar devices.

In summary, the provided document explicitly states that clinical data was not required for this 510(k) submission. The acceptance criteria were primarily met through non-clinical performance testing (design reviews, risk analysis, system requirements verification) and demonstrating substantial equivalence to existing, cleared devices (the predicate Lumify system and the Sparq system which already has an Ophthalmic indication for the L12-4 transducer), ensuring the new Ocular preset did not introduce new safety or effectiveness concerns.

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The intended use of EPIQ Series 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 (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal. Transvaginal. Lung.

· The clinical environments where EPIQ Series 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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

· However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the mL26-8 transducer:

The mL26-8 is a linear array transducer designed primarily for superficial high-resolution imaging in Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, and Small Organ (Breast, Thyroid, Testicle). The mL26-8 has a frequency of 6-13.33 MHz.

The provided text describes the regulatory clearance of a Philips EPIQ Series Diagnostic Ultrasound System with a new mL26-8 transducer (K231190). However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm's performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K212704) and a reference device (K162329) by adhering to general safety and performance standards for diagnostic ultrasound systems. The "acceptance criteria" mentioned in the document refer to the successful completion and meeting of requirements for non-clinical performance tests, and design control activities for the ultrasound system itself, not for an AI or algorithmic component.

Specifically, the document states:

• "VIII. Clinical Data: The proposed EPIQ Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes: Design features, Indications for use, Fundamental scientific technology, Non-clinical performance testing, Safety and effectiveness."
• "IX. Conclusion: For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed EPIQ Series Diagnostic Ultrasound System, including mL26-8, met the intended use."

Therefore, based on the provided text, I cannot complete the table or answer the specific questions related to AI/algorithm performance. The document describes the clearance of an ultrasound hardware system, not an AI-powered diagnostic algorithm.

If you have a document that describes the validation of an AI component of this or another device, please provide that text.

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ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:

Fetal/obstetric
Gynecological /Pelvic
Abdominal
Renal
Cardiac
Pediatric
Small organ (thyroid, breast, testes, etc.)
Musculoskeletal (conventional & superficial)
Peripheral vascular
Ophthalmic

Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).

The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.

The provided text describes the ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System, which is a general-purpose ultrasound system. However, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device.

*Crucially, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in a clinical or AI-assisted context, as would be expected for a device incorporating AI/ML.

The document states: "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This means there was no clinical study performed (or at least, none submitted to the FDA for this clearance) that would establish the type of performance metrics typically associated with AI/ML devices such as sensitivity, specificity, accuracy, or reader improvement.

The non-clinical performance data section refers to compliance with consensus standards for safety, electromagnetic compatibility, usability, software life cycle, and risk management, along with acoustic output limits. These are general device standards, not specific performance metrics against a clinical ground truth for diagnostic accuracy.

Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:

1. Acceptance Criteria and Reported Performance (Table): The document does not define specific performance acceptance criteria for diagnostic capabilities, nor does it report device performance against such metrics. It primarily focuses on compliance with general safety and performance standards relevant to ultrasound systems and substantial equivalence to a predicate device.

2. Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): The document explicitly states that "The ImSonic TR-1 Diagnostic Ultrasound System and its transducers did not require clinical data to support the determination of substantial equivalence." This signifies that the type of clinical performance study (with test sets, ground truth establishment, expert readers, etc.) typically performed for AI/ML devices to demonstrate diagnostic accuracy was not conducted or presented here.

3. Training Set (Size, Ground Truth Establishment): As no clinical study was described for performance evaluation, there is no information about an AI/ML model's training set, its size, or how ground truth for that training set was established.

In summary, the provided document is a regulatory submission for a general-purpose ultrasound system based on demonstrating substantial equivalence to existing devices through compliance with established safety and operational standards. It does not describe the development or validation of an AI/ML component with specific diagnostic performance claims against clinical ground truth.

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The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300C, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.

5000 Compact series is indicated for diasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.

The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients.

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. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

The proposed Philips 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are general purpose, compact, battery or alternating current (AC) powered, software controlled, diagnostic ultrasound systems. The ultrasound system is housed in a portable, laptop-style chassis. The ultrasound system function is to acquire ultrasound data and to display the data in various modes of operation. The ultrasound system components include the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger. The ultrasound system can be attached to an optional cart. The cart height is adjustable to accommodate a range of operator heights and operating positions. The cart has wheels for maneuverability and may provide isolated power for system and peripheral components (such as black and white image printer or a report printer).

The 5000 Compact Series Ultrasound Systems comprises of different configurations which differ in terms of features, transducer options, and license options (features available as purchasable options in addition to the standard features available in the system. The types of options available include clinical options, QLAB Advanced Quantification Software, protocols, imaging capabilities, connectivity capabilities, etc.). The 5500G is the primary configuration with the most available capabilities. Identical software architecture is used in all configurations and all configurations are derived from a common codebase. Similarly, the hardware is same for all configurations. All the 5000 Compact Series Ultrasound System configurations are compatible with existing Philips transducers cleared in Philips Affiniti Ultrasound System (K200304). 5500 Compact Series POC (point-of-care) configurations leverage POC features from the CX50 platform (K162329) to enable efficient POC ultrasound capability.

There is no information in the provided text about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification from Philips Ultrasound LLC to the FDA for "5000 Compact Series Ultrasound Systems." This type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove specific performance metrics against an AI.

The document states:

• "The proposed 5000 Compact Series Ultrasound Systems did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes: Design features, Indications for use, Fundamental scientific technology, Non-clinical performance testing, Safety and effectiveness."
• "For testing, all pre-determined acceptance criteria were met." However, it does not specify what those acceptance criteria were or what performance data was collected to meet them.

Therefore, I cannot provide the requested information from the provided text, as it does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts or their qualifications.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set (as no training set for an AI is mentioned).
9. How ground truth for a training set was established.

The document focuses on demonstrating that the new ultrasound systems are substantially equivalent to existing, cleared predicate devices (Philips Affiniti Ultrasound System and Philips CX 50 Ultrasound Systems) based on their technological characteristics, intended use, and safety considerations, rather than reporting on a study with specific performance acceptance criteria for an AI or imaging diagnostic algorithm.

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Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric

The modified/proposed Xperius Ultrasound System is a general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation.

The provided text is a 510(k) summary for the Philips Xperius Ultrasound System (K182529). It details the device's indications for use and compares its technological characteristics to predicate devices. However, it explicitly states that no clinical studies were required or performed to determine substantial equivalence. Therefore, it is not possible to provide information about acceptance criteria, device performance from a test set, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these items are typically derived from clinical or performance studies.

The document indicates that substantial equivalence was demonstrated through non-clinical performance data and attributes such as design features, indications for use, and fundamental scientific technology.

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

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The submission explicitly states "The proposed Xperius Ultrasound System did not require clinical studies since substantial equivalence to the currently marketed predicate devices... was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness." As such, there are no reported device performance metrics against specific acceptance criteria from a clinical or performance study.

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

This information is not available in the provided document. No clinical or performance test set was used according to the submission.

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

This information is not available in the provided document. No clinical or performance test set was used, and therefore no experts were involved in establishing ground truth for such a test set.

4. Adjudication Method for the Test Set

This information is not available in the provided document. No clinical or performance test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not available in the provided document. No clinical studies, including MRMC studies, were performed.

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

This information is not available in the provided document. The device is an ultrasound system with various modes, not an AI algorithm. No standalone performance study of an algorithm was mentioned.

7. The Type of Ground Truth Used

This information is not applicable as there were no clinical or performance studies generating results that would require ground truth for comparison. Substantial equivalence was based on non-clinical performance data and comparison to predicate devices, not on a new clinical evaluation requiring ground truth.

8. The Sample Size for the Training Set

This information is not available in the provided document. The document describes an ultrasound system, not a device that underwent machine learning training with a specific training set.

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

This information is not applicable as there is no mention of a training set for a machine learning model.

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