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The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows:

• IPL with a spectrum of 400-1200nm (with different filters) is indicated for:

  • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
  • Cutaneous lesions, including warts, scars and striae.
  • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
  • Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.
  • Mild to moderate inflammatory Acne (Acne Vulgaris).

• Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for:

  • The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
  • The non-ablative treatment of facial wrinkles.
  • The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.

• The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for:

  • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

• Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for:

  • Treatment of pigmented lesions.
  • Removal of dark tattoos.

(*) Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.

The Lumenis Stellar M22 System is multi-application, multi-technology system intended for use in aesthetic dermatologic procedures.

The Stellar M22 System operates with four (4) treatment handpieces options (for connection capability), within serial operational mode:

• Intense Pulsed Light (IPL) handpiece;
• Multi-Spot Nd:YAG Laser handpiece;
• ResurFX Laser module and handpiece;
• Q-Switched Nd:YAG laser handpiece.

The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:

• The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
• The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes of: 2mm x 4mm, 6 mm, and 9 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
• The Q-Switched Nd:YAG handpiece has both disposable and gold-plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm, while the metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

This FDA 510(k) clearance letter for the Stellar M22 device does not contain any information about acceptance criteria or a study proving the device meets said criteria for an AI/algorithm-driven component.

The document explicitly states:

• "No new clinical validation was required to support the Stellar M22 as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that no new clinical study was performed for this specific submission to demonstrate performance.
• The modifications described are "mainly due to the addition of new Hardware to serve marketing, business and serviced purposes," and "to maintain Lumenis' high-level service capabilities to the professional end-users and their patients, through establishment of a secure transmission of technical information to the cloud for further analysis and rapid problem-solving." This strongly suggests the changes are related to connectivity and serviceability, not a new AI/algorithm feature requiring performance validation.

Therefore, I cannot provide the requested information from the provided text. The document describes a device modification for an existing system (Stellar M22) and asserts substantial equivalence to its predicate based on the fact that the changes are primarily hardware upgrades for service and marketing, and the clinical validation of the predicate device is considered applicable.

There is no mention of any AI component, performance criteria for such a component, or a study validating its performance in this submission.

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Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope, Exoscope and relevant accessories.

During surgical procedures, Stellar Imaging System is used to provide real-time visible and fluorescence imaging similar to that provided by conventional imaging system used in endoscopic surgery and innovative 3D visible and fluorescence imaging in endoscopic surgery. Besides, Stellar Imaging System is also used to provide real-time fluorescence confirmation in open field.

The Stellar Imaging System including the laparoscope and the exoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using a camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

The provided text is a 510(k) Summary for the Stellar Imaging System. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety standards. It does not contain information about the acceptance criteria for a study, the results of such a study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The section titled "VII. Performance data" only lists the non-clinical tests conducted to verify compliance with various safety and performance standards. It states: "Performance comparison testing are also conducted on the subject device and predicate/reference device, demonstrate that the proposed system performs according to specifications and functions as intended." However, no specific details or results of this performance comparison testing are provided within this document.

Therefore, I cannot fulfill your request for the specific information you asked for, as it is not present in the provided text.

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The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.

A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).

The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.

This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.

The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The provided document is a 510(k) Summary for the Bausch + Lomb Stellaris Elite™ vision enhancement system. It primarily focuses on demonstrating substantial equivalence to a predicate device after software and hardware updates, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, many of the requested categories cannot be fully addressed in the traditional sense of a clinical or performance study aimed at defining and meeting specific analytical or clinical performance metrics. The document describes how substantial equivalence was demonstrated, which involves various types of testing, but not a study designed to prove new performance claims against defined acceptance criteria.

Below is the information extracted and interpreted based on the context of this 510(k) submission, highlighting what is available and what is not.

Acceptance Criteria and Device Performance Study for K232084

This 510(k) submission (K232084) is for updates to the Bausch + Lomb Stellaris Elite™ vision enhancement system, not for a new device making novel performance claims. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170052 Stellaris Elite™ vision enhancement system) after changes to the User Interface Computer System on Module (SOM) and an update to the operating system from Windows XP to Windows 10. Consequently, the "acceptance criteria" and "device performance" are framed in terms of meeting regulatory standards and maintaining performance equivalent to the predicate device, rather than achieving specific performance thresholds for a novel diagnostic or therapeutic claim.

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

Given the nature of this 510(k) for system updates, the "acceptance criteria" are regulatory compliance and maintained functionality, rather than specific numerical performance metrics for a clinical task.

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a dataset for AI or clinical study. Instead, it refers to "representative units" for hardware testing (electrical safety, EMC) and software verification/validation.

• Test Set Sample Size: Not applicable in the context of an AI-driven clinical test set. Testing was performed on the device itself and its software.
• Data Provenance: Not applicable as no patient data or image data was used for a test set. This submission is for hardware/software updates to an ophthalmic surgical system. The standards cited (IEC standards for electrical safety, EMC, software lifecycle) are international regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set (e.g., diagnostic labels, disease states) was established by experts in this submission, as it's not a diagnostic AI device.

4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ophthalmic surgical system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. For software and hardware validation, the "ground truth" would be the functional requirements and established performance specifications of the predicate device and relevant international standards.

8. The sample size for the training set
Not applicable. This device does not use a "training set" in the sense of machine learning for interpretation or diagnosis.

9. How the ground truth for the training set was established
Not applicable.

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STELLAR Knee is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. STELLAR Knee is indicated for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The STELLAR Knee is installed on a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

The main purpose of the STELLAR Knee is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. STELLAR Knee includes software and surgical instruments.

STELLAR Knee uses established surgical navigation techniques to provide information to help track patient bony landmarks in real time to assist the surgeon in determining resection angles and measurements as required in knee replacement surgery. STELLAR Knee allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the surgical instruments. The software locates in a 3D reference frame the instruments which include marker arrays. All collected coordinates are treated by software algorithms to provide the surgeon with the relevant orientation of the tracked cutting quide. STELLAR Knee software is installed on a wearable Head Mounted Device (HMD) which includes an embedded camera and displays intraoperative information to the user. This near-eye display allows the surgeon to look at the HMD screen or the field of view when needed.

The provided text describes a 510(k) premarket notification for the STELLAR Knee device, which is a stereotaxic system for Total Knee Replacement. However, the document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The "Non-clinical performance testing" section briefly mentions that "Bench testing was conducted in order to demonstrate that STELLAR Knee performs according to its requirements and specifications when installed on the Head Mounted Device. In particular, overall system repeatability and accuracy were tested." It also states, "The results demonstrated that the STELLAR Knee performs according to its specifications and functions as intended."

However, information regarding specific quantitative acceptance criteria (e.g., accuracy thresholds in mm or degrees), the reported device performance against these criteria, sample sizes used, data provenance, ground truth establishment, or any comparative effectiveness studies (MRMC) is not provided in this document.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor the details of any study that proves the device meets specific acceptance criteria based on the given input. The document focuses on establishing substantial equivalence with a predicate device based on similar indications for use, operating principles, and general performance testing, without detailing the results of those performance tests in a quantitative manner against predefined acceptance criteria.

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The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.

The provided text describes the regulatory clearance for the "Stella" dental implant system. It does not contain information about acceptance criteria or a study demonstrating the device meets performance criteria in the context of AI/ML or diagnostic applications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies for an AI/ML device is not present in the provided document.

However, I can extract the non-clinical testing performed to support the substantial equivalence claim for the Stella dental implant system.

Here's the relevant information that is available:

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

This information is not provided in the context of an AI/ML device's diagnostic performance. The document only lists types of non-clinical tests performed for physical characteristics of the dental implant system, and states that the "Stella" has "similar fatigue testing results to the predicate devices in the market" without providing specific acceptance criteria or quantitative results for these comparisons.

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

Not applicable to this document. The document describes a medical device (dental implant), not a diagnostic algorithm.

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 to this document.

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

Not applicable to this document.

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 to this document.

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

Not applicable to this document.

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

Not applicable to this document. The "ground truth" for a physical device like a dental implant would be engineering specifications and material properties, validated through physical testing, not expert consensus on images or pathology.

8. The sample size for the training set:

Not applicable to this document, as it does not describe an AI/ML algorithm.

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

Not applicable to this document.

Summary of Non-Clinical Testing (as described in the document for the physical device Stella, not an AI/ML component):

The document highlights the following non-clinical tests performed to support substantial equivalence of the Stella dental implant system:

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Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs.

Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs.

Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D.

The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors.

Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports.

The user controls the exposure using a manual hand-switch, implementing the dead man functionality.

An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.

The provided document is a 510(k) Premarket Notification from FONA S.r.l. to the FDA for their Stellaris dental X-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to relevant standards.

The document does NOT describe the acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The Stellaris devices are dental X-ray systems (2D and 3D, with and without cephalometric capabilities). The document explicitly states:

• "The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission)..." (page 8)
• "...the 3D sensor has been replaced with a 2D sensor." (page 10)
• "The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices." (page 7)

There is no mention of any AI or machine learning components within the device itself for diagnostic or image processing purposes that would require specific performance criteria or a study as outlined in the request. The "reconstruction algorithm" mentioned is standard for CT and panoramic imaging, not an AI/ML algorithm requiring separate clinical performance validation from the device's image acquisition capabilities.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes a traditional 510(k) submission for an imaging device, demonstrating substantial equivalence through technical characteristics, safety standards (IEC, EN), software standards (EN 62304), and biocompatibility (ISO 10993-1).

In summary, none of the requested information regarding AI/ML acceptance criteria or a comparative study proving device performance against such criteria can be found in this document.

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For Prescription and Home Use by prescription from a medical professional:

The Stella BIO is a neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions

As a powered muscle stimulator, Stella BIO is indicated for the following conditions:

• · Relaxation of muscle spasms,
• · Prevention or retardation of disuse atrophy,
• · Increasing local blood circulation,
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
• · Maintaining or increasing range of motion,
• · Muscle re-education.

As a transcutaneous electrical nerve stimulator for pain relief. Stella BIO is indicated for the following conditions:

• · Symptomatic relief and management of chronic (long-term), intractable pain,
• · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.

As a biofeedback device, Stella BIO is indicated for:

· Biofeedback, relaxation and muscle re-education.

As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: · Helps to relearn voluntary motor functions of the extremities.

As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions:

· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.

· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.

Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.

Environments of Use: Clinics, hospital and home environments.

Platform: Stella BIO is a battery-powered, wireless device, accessible through software.

The Stella BIO is a neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device, designed for stationary use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient.

Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.

For the Prescription and Home Use by prescription from a medical professional Software License, the medical professional has the ability to adjust, monitor and progress the therapy. This License comes with two User Manuals:

• User Manual for the medical professionals (including instructions on how to adjust parameters ● of the programs and prescribe exercises for patients)
• User Manual for the patient (including instruction on how to use programs prescribed and adjusted by the medical professional)

The Stella BIO is a battery-powered, wireless device, accessible through software on a mobile device (PC, tablet or smartphone). Statistics reqarding the completed treatment can be retrieved from the PC.

In order to gain a proper understanding of Stella BIO, it is important to read the manual before beginning to use the Stella BIO.

This document is a 510(k) summary for the Stella BIO device, which is a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. The purpose of this summary is to demonstrate that the Stella BIO device is substantially equivalent to a legally marketed predicate device, the Stiwell med4 (K080950).

Key Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the Stella BIO to its predicate device across various "designations" (Powered Muscle Stimulator, Functional Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, Incontinence Programs, Biofeedback). Instead of defining explicit acceptance criteria with numerical targets as one might for a diagnostic AI, the acceptance criteria here are implicitly met by demonstrating that any differences between the new device and the predicate device, or adherence to relevant voluntary standards (IEC, ANSI/AAMI, FDA guidance), do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" table below is constructed by extracting the key comparative metrics and the conclusions drawn regarding their impact on safety and effectiveness.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

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Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.

Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.

The provided text describes the regulatory acceptance of the Lumenis Stellar M22 for use in dry eye disease management, focusing on the clinical study that supports its effectiveness and safety. However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or any MRMC (Multi-Reader Multi-Case) comparative effectiveness study. Similarly, there's no mention of standalone algorithm performance or the sample size and ground truth establishment for a training set if an AI component were present.

The information primarily revolves around the performance of the IPL device itself, in conjunction with Meibomian Gland Expression (MGX), and is evaluated through clinical endpoints in human subjects.

Therefore, for aspects related to AI/algorithm performance, ground truth, and MRMC studies, the provided text does not contain the necessary details. I will answer the questions based on the information available in the text, and clearly state when information is not present.

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

Acceptance Criteria and Device Performance (Based on Clinical Study Outcomes)

The device's acceptance is primarily based on its clinical performance in improving a specific sign of Dry Eye Disease (DED) and its safety profile.

• IPL+MGX arm: Change in TBUT from baseline (BL) to follow-up (FU) was 1.99 ± 0.36 sec.
• Control (Sham+MGX) arm: Change in TBUT from BL to FU was 0.75 ± 0.34 sec.
• Between-group mean difference in TBUT: 1.24 ± 0.50 sec.
  Support for "meaningful clinical benefit" based on exploratory and post-hoc analyses (e.g., proportion of patients improving by two or more TBUT severity categories, proportion improving to non-MGD TBUT). |
  | Secondary Effectiveness Endpoints: Improvement in self-reported DED symptoms (OSDI questionnaire, Eye Dryness Score (EDS) VAS). | Not Met: The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (similar overall mean improvement in both groups, no statistically significant difference between groups).
• OSDI p=(b)(4), EDS VAS p=(b)(4).
  However, exploratory protocol-planned analysis of "OSDI responders" (OSDI (b)(4) interpreted as improvement to "mild or better") showed clinical benefit for active IPL treatment group ((b)(4)%) vs. control group ((b)(4)%). This outcome supports clinically meaningful benefit for a proportion of the study population. |
  | Supportive Effectiveness Endpoints (Signs of DED): Change in Meibomian Gland Score (MGS). | Clinical Benefit: Exploratory analysis of change in MGS showed clinical benefit for the IPL treatment group.
• Improvement of (b)(4) units in active arm vs. (b)(4) units in control arm.
• Between-group difference of (b)(4) units.
  This outcome supports clinically meaningful benefit for a subset of the study population. |
  | Safety: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events (UADEs). | Acceptable:
• No Serious Adverse Events (SAEs) or UADEs reported.
• AE incidence: 8.9% in IPL active treatment arm (2 ocular AEs, 2 skin AEs) compared to 20% incidence in the control arm.
• With proper eye protection, no ocular AEs attributed to the IPL system were reported. |
  | Other Non-Clinical Criteria (addressed through testing/declarations for device components):
• Thermal Safety
• Electrical Safety and Electromagnetic Compatibility (EMC)
• Biocompatibility
• Software Verification, Validation, and Hazard Analysis | Met:
• Thermal safety assessed (leveraging previous clearances).
• Complies with IEC 60601-1 and IEC 60601-1-2 (similar to previous K193500 device).
• Handpiece identical in materials and manufacturing to K193500, so previous biocompatibility assessments are applicable. Warnings for coupling gel eye contact included.
• Consistent with FDA guidance for software in medical devices; moderate Software Level of Concern (LOC); risks addressed by labeling and risk management process. |

Study Details:

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

   • The document mentions "Up to male or female subjects". It does not explicitly state the final enrolled sample size. However, it indicates:
     • Type I error of 0.05 (two-tailed test)
     • Type II error of (b)(4) (power = (b)(4))
     • 1:1 ratio of Treatment to Control
   • Data Provenance:
     • The study was a "multi-center, prospective, randomized, sham-controlled, superiority study."
     • Country of Origin: Not explicitly stated, but Lumenis Ltd. is based in Yokneam, ISR (Israel). Clinical trials are often multi-national, but this is not specified.
     • Retrospective or Prospective: Prospective.

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

   • The clinical study evaluates the device's effect on clinical endpoints directly measured or self-reported by patients (TBUT, OSDI, EDS, MGS). These are objective or subjective measures, not interpretations by experts needing to establish ground truth from, for example, images.
   • Therefore, the concept of "experts used to establish ground truth" in the typical sense (e.g., for image annotations) does not apply to this clinical trial design. Measurements like TBUT and MGS are taken by trained clinical personnel, and OSDI/EDS are patient-reported.

3. Adjudication Method for the Test Set:

   • Not applicable as the study relies on direct clinical measurements and patient self-assessment, not interpretive tasks requiring adjudication like image reads.

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

   • No, an MRMC comparative effectiveness study was not done. The study was a clinical trial evaluating a device's effect on physiological and symptomatic endpoints, not a study assessing the performance of human readers with or without AI assistance.
   • Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI assistance was being evaluated for human readers.

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

   • No, this was not done. The product being evaluated is a medical device (IPL system), not an AI algorithm. The performance discussed is the direct effect of the device on patients.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context refers to the clinical endpoints measured in the study:
     • Tear Break-up Time (TBUT): A direct physiological measurement (time from blink to tear film break-up).
     • Meibomian Gland Score (MGS): An objective clinical scoring system for meibomian gland function.
     • OSDI and EDS VAS: Patient-reported outcome measures (subjective symptoms).
   • These are considered the gold standard for evaluating DED and MGD in clinical trials. There is no mention of pathology or other external outcomes data beyond these clinical measures.

7. The Sample Size for the Training Set:

   • Not applicable. The document describes a clinical trial for a medical device, not the training of an AI model. Therefore, there is no "training set" in the context of an algorithm.

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

   • Not applicable. As there is no AI model training described, there is no "ground truth for a training set" to be established.

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The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

• The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
  • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
  • Cutaneous lesions, including warts, scars and striae O
  • Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
  • Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
  • Mild to moderate inflammatory Acne (Acne vulgaris) o
• The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
  • The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
  • The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
  • The non-ablative treatment of facial wrinkles o
• . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
  • Use in dermatological procedures requiring fractional skin resurfacing and O
    coagulation of soft tissue

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:

• Removal of dark tattoos O
• o Treatment of pigmented lesions

*Note

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:

• Stellar Intense Pulsed Light (IPL) handpiece; ●
• . Multi-Spot Nd:YAG laser handpiece;
• ResurFX non-ablative laser handpiece: ●
• Q-Switched Nd:YAG laser handpiece. ●

The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:

• The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, . 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
• The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
• . The Q-Switched Nd:YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The provided text is a 510(k) summary for the Stellar M22 for Intense Pulsed Light (IPL) and Laser system. This document outlines the device's intended use, technological characteristics, and compares it to a predicate device (M22 System, K170060) to establish substantial equivalence.

However, the summary does not include specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as often seen in clinical performance studies with specific endpoints. Instead, it describes "Performance Data" in the context of design verification, compliance with standards, and software validation to demonstrate that modifications to the device do not raise new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not detailed in this type of regulatory submission, as it focuses on demonstrating substantial equivalence rather than proving a specific diagnostic accuracy or treatment efficacy de novo.

Below is a summary based on the information provided, with "N/A" for information not present in the document.

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

The document does not explicitly present acceptance criteria in a quantitative table format that measures specific performance metrics against a defined threshold. Instead, it focuses on demonstrating that the Stellar M22 device's modifications do not introduce new safety or effectiveness concerns compared to its predicate. The "reported device performance" is framed in terms of functional verification and compliance with standards.

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

N/A - The document describes general performance data related to engineering verification and validation, and compliance with standards. It does not refer to a clinical "test set" with a specific sample size of patients or images for diagnostic or therapeutic performance evaluation. The data provenance is also not specified in terms of country of origin or retrospective/prospective nature, as this is not a clinical study report.

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

N/A - No clinical "test set" requiring ground truth established by experts is described in this regulatory submission for substantial equivalence.

4. Adjudication method for the test set

N/A - No clinical "test set" or adjudication method 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

N/A - This document does not describe an MRMC comparative effectiveness study or involve AI assistance for human readers. The device is a laser and IPL system for dermatological procedures, not an AI-powered diagnostic tool.

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

N/A - This device is a medical instrument (laser and IPL system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

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

N/A - As there is no clinical "test set" for performance evaluation in the context of diagnostic accuracy or treatment efficacy against a reference standard, the concept of ground truth in that sense is not detailed. The performance data focuses on engineering and safety compliance.

8. The sample size for the training set

N/A - The document does not describe a "training set" in the context of machine learning or AI algorithms.

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

N/A - Not applicable, as there is no mention of an AI training set or related ground truth.

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