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The SOLOPASS 2.0 System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intraventricular catheter.

The SOLOPASS® 2.0 System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy without the use of preoperative imaging. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® 2.0 System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for patients 6 months and older.

The Solo+ Tympanostomy Tube Device (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation (blue) button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the 510(k) clearance for the Solo+ Tympanostomy Tube Device (TTD). While it details the device's characteristics, comparison to predicate devices, and general non-clinical testing, the clinical study information focuses on comparative effectiveness and patient safety/success, rather than specific acceptance criteria for performance metrics that would typically be seen in a study evaluating an AI device or a device with quantifiable performance outputs like accuracy, sensitivity, or specificity.

The Solo+ TTD is a surgical instrument, and its "performance" in this context is primarily related to its ability to successfully place a tympanostomy tube and maintain patient safety. Therefore, the "acceptance criteria" discussed here are related to the success rate of tube placement and the absence of serious adverse events.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study

The provided document describes a clinical study to support the substantial equivalence of the Solo+ TTD for an expanded patient population (pediatric patients 6 months and older) compared to its primary predicate (K232702, which was indicated for patients 6-24 months) and a secondary predicate (K221254, which already covered patients 6 months and older). The "acceptance criteria" are implicitly derived from the successful outcomes observed in the study and their comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • For the Solo+ TTD (proposed device) in patients ≥24 months: 20 pivotal cohort patients (36 ears).
  • For the primary predicate Solo+ TTD (K232702) in patients ≥6 to <24 months: 20 patients (corresponding to 40 ears, assuming 2 ears per patient).
  • For the secondary predicate Hummingbird TTS (K221254) in patients ≥2 years: The number of patients/ears is not explicitly stated, but percentages are provided.
• Data Provenance: The study was a multi-site study. The country of origin is not explicitly stated in the provided text. It is a prospective clinical study as it describes active enrollment and follow-up of patients.

3. Number of Experts and Qualifications for Ground Truth

This type of device (a surgical instrument) does not typically involve "experts establishing ground truth" in the same way an AI diagnostic device does. The "ground truth" for success or adverse events is observable clinical outcomes. The procedures were performed by medical professionals, presumably surgeons or ENTs, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for classifying study outcomes or establishing ground truth, as it's not a diagnostic study where independent review for consensus is typically required. Clinical outcomes (successful placement, adverse events) are typically reported by the treating physician and/or verified by study monitors.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an interpretive diagnostic tool that involves human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

6. Standalone Performance Study

The clinical study described is a standalone performance evaluation of the Solo+ TTD (proposed device) in the specified patient population (≥24 months) to demonstrate its safety and effectiveness, and compare its outcomes to predicate devices. It is not an "algorithm-only" study as there is no AI component mentioned for this device. The non-clinical engineering tests (Table 2 and 3) also represent standalone evaluations of the device's physical and functional characteristics.

7. Type of Ground Truth Used

The ground truth used for the clinical study was observable clinical outcomes. This includes:

• Successful placement of the tympanostomy tube as planned.
• Whether additional instruments were needed during placement.
• The occurrence of device or procedure-related serious adverse events.

8. Sample Size for the Training Set

This document describes a medical device (a surgical instrument), not a software or AI device that requires a "training set" for an algorithm. Therefore, there is no training set sample size.

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

As there is no AI component or training set, this question is not applicable.

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The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to:

• · Complete heart block
• · Sinus bradycardia
• Sick sinus syndrome
• · Bradycardia with congestive heart failure
• · Cardiac complications during invasive or surgical procedures
• · Support, management, and evaluation of a patient before permanent pacemaker implantation
• · Support during permanent pacemaker replacement
• · Interventional cardiology procedures where pacing is required

The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)

The provided document is a 510(k) premarket notification letter from the FDA to Solo Pace, Inc. regarding their device, Solo Pace Control. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

• Specific acceptance criteria and reported device performance in a table format. It mentions "performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents," and "The results of the above performance testing met the specified acceptance criteria." However, it does not detail what those criteria were or the specific performance results.
• Sample sizes used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on regulatory aspects, such as the device's classification, indications for use, comparison to a predicate device, and a high-level summary of performance testing categories (e.g., electrical safety, EMC, software verification, cybersecurity). It confirms that testing was done and met acceptance criteria, but it does not provide the granular detail required to answer your specific questions about the study design, ground truth establishment, or specific performance metrics.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested detail. The document confirms that such studies were performed and met criteria, but it does not include the specifics of those studies.

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The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons and urologists.

The intended use of the DEXTER ENDOSCOPE ARM is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The DEXTER ENDOSCOPE ARM is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, DEXTER ENDOSCOPE ARM is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the DEXTER ENDOSCOPE ARM are general surgeons, gynecologists, cardiac surgeons and urologists.

The intended use of the ARTip solo is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The ARTip solo is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, ARTip solo is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic, decompression fixation, wedge resection, lunq biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the ARTip solo are general surgeons, gynecologists, cardiac surgeons and urologists.

DEXTER ENDOSCOPE ARM and ARTip solo + ARTip solo voice are based on the same concept as the already cleared SOLOASSIST II + Voice Control (K200473) and differ only in minor details. All 3 robotic arm systems emulate an arm operating in multiple degrees of freedom. The intended use of the three robotic arm systems is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The surgeon can control the arm with either a joystick, voice control, or by pressing a button on the distal end of the arm. Movement is controlled by 3 motorized axes. The endoscopic camera is registered in the TROCAR POINT, which serves as the pivot point. Starting from this zero point, the device independently calculates the required individual movements of the axes to achieve the desired overall movement. The system offers a wide range of motion, allowing a 360° panoramic view with the endoscope tilted up to 90° from the vertical. Despite their wide range of motion, all arms are lightweight and compact and are attached directly to the operating table with a quick-release clamp. Only a STERILE COVER is required for safe use.

The ARTip solo is functionally identical to the already cleared SOLOASSIST II (K200473), but differs only in the color and inscription of the covers and the visual design of the control panel on the arm.

The ARTip solo can also be controlled with the ARTip solo voice. This is also identical to the already cleared VOICE CONTROL (K200473) except for the color and inscription. The ARTip solo is not compatible with the VOICE CONTROL (K200473).

In addition, the ARTip solo can also be controlled with a joystick. It can only be controlled with the JOYSTICK-IH-IA or JOYSTICK-RH-IIA, which are specially made for the ARTip solo and are only compatible with it.

DEXTER ENDOSCOPE ARM is the trade name of the SOLOASSIST IID, which was developed within the SOLOASSIST II. The special feature of the DEXTER ENDSCOPE ARM is that it provides an interface to a customer-specific device and can be controlled by it.

The arm can also be controlled by the JOYSTICK LH and JOYSTICK RH.

The SOLOASSIST IID has its own CANTILEVER, JOINT, PROBE PIN and ENDOSCOPE CLAMP, which in combination with a tension sleeve hold the endoscope.

I am sorry, but the provided text does not contain the detailed information necessary to complete some sections of your request. Specifically, it lacks data on:

• Specific acceptance criteria for individual performance metrics.
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone algorithm performance.
• Type of ground truth for the test set.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on demonstrating substantial equivalence to a predicate device based on technological similarity and non-clinical testing. It states that new devices "can be classified as equally safe and effective as the predicate device" based on these tests, but does not provide specific performance metrics or detailed study designs for acceptance criteria.

Therefore, I cannot populate all the requested fields. However, I can provide the information that is present in the document which describes the testing and conclusions regarding the devices' safety and effectiveness.

Here's a summary of the available information based on your request:

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

The document does not explicitly list specific numerical acceptance criteria or quantitative performance metrics for the device. Instead, it refers to non-clinical tests carried out with predicate devices and additional tests for the new devices to "prove the safety and effectiveness with regard to the differences to the predicate device." The conclusion is that the new devices are "as safe and effective as the predicate device."

• Acceptance Criteria: Not explicitly stated with numerical values. The implicit acceptance criterion is likely to demonstrate equivalence in safety and effectiveness to the predicate device through successful completion of the listed non-clinical tests and software verification.
• Reported Device Performance: The document concludes that "The non-clinical tests have shown that the SOLOASSIST IID, ARTip solo voice and SOLOASSIST II + VOICE CONTROL are as safe and effective as the predicate device." No specific quantitative performance data (e.g., accuracy, precision, error rates) are provided.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text, specific metrics are not detailed)

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

The document does not specify sample sizes for test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective) as the tests described are non-clinical, likely bench testing.

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. The tests mentioned are non-clinical (e.g., temperature, lifetime, functional tests) and do not involve expert-established ground truth in the context of diagnostic interpretation.

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

Not applicable, as expert adjudication for ground truth is not mentioned for the non-clinical tests.

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. The device (SOLOASSIST IID / DEXTER ENDOSCOPE ARM, ARTip solo, ARTip solo voice, SOLOASSIST II, VOICE CONTROL) is described as a robotic computer-driven system to hold and position endoscopes, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is outside the scope of this device's intended use and the provided documentation.

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

This refers to a standalone performance of the entire device system (robotic arm with its software and controls), not a standalone algorithm in the context of AI diagnostic performance. The non-clinical tests described (e.g., temperature, lifetime, functional tests for various components and control methods) represent tests of the device in its standalone (intended operational) capacity, without human intervention for evaluation of diagnostic output. The device itself is designed to be operated by a human surgeon.

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

For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, physical measurements, and functional requirements of the device and its components (e.g., a power supply providing the correct voltage, a quick-release connector functioning as designed, voice commands being correctly interpreted). It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The sample size for the training set

Not applicable, as the document describes a robotic surgical assistant system and associated controls, not an AI algorithm that requires a "training set" in the machine learning sense for diagnostic purposes. The software changes mentioned are related to bug fixes, parameter additions, and compatibility checks, not statistical model training.

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

Not applicable, for the same reason as point 8.

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The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.

The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.

To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.

The provided text describes the Solo+ Tympanostomy Tube Device (TTD) and its substantial equivalence determination. However, it does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance, as typically seen in submissions for AI-powered devices. The device described, the Solo+ TTD, is a physical medical device for placing tympanostomy tubes, not an AI/software device.

Therefore, many of the requested points in your prompt are not applicable to the provided document. I can, however, extract the relevant information regarding the clinical study performed to demonstrate the device's safety and effectiveness compared to a predicate device.

Here's the closest possible answer based on the provided text, focusing on the clinical study conducted for the physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The study conducted for the Solo+ Tympanostomy Tube Device (TTD) was a multi-site clinical study designed to demonstrate substantial equivalence to its predicate device, the Preceptis Hummingbird TTS, for in-office tympanostomy procedures in pediatric patients.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the "acceptance criteria" (though not explicitly labeled as such, these are the primary outcomes measured for comparison of substantial equivalence) as clinical outcomes compared between the Solo+ TTD and the predicate device.

2. Sample Size and Data Provenance:

• Test Set Sample Size: A total of 20 patients (40 ears).
• Data Provenance: Conducted in a multi-site study across 2 sites. The country of origin is not explicitly stated, but the applicant company is based in Ireland. The study was a clinical study, implying a prospective design for the purpose of demonstrating substantial equivalence.

3. Number of Experts and Qualifications: Not applicable. This was a clinical study involving patients and the mechanical placement of a device, not an AI/image-based diagnosis requiring expert readers for ground truth establishment.

4. Adjudication Method: Not applicable. (See #3)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This was not a study evaluating human reader performance with or without AI assistance but rather the performance of a physical surgical device.

6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used: The "ground truth" for this study was the observed clinical outcome of the tympanostomy tube placement (i.e., whether the tube was successfully placed and if additional instruments were needed). This is essentially outcomes data directly observed during the procedure and initial follow-up.

8. Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How Ground Truth for Training Set was Established: Not applicable. (See #8)

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The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.

The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.

The provided FDA 510(k) summary for the SoloSmart Injection Pen Adapter does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-based medical device. This document describes a traditional medical device (an adapter for injection pens) and its substantial equivalence to a predicate device, focusing on its physical and functional characteristics, rather than AI performance.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

The document discusses performance data related to the physical device and its ability to accurately record and transmit dosing information, but not the performance of an AI algorithm.

Here's a breakdown of what is in the provided text, and why it doesn't align with the request for AI/ML device performance:

• Device Type: SoloSmart Injection Pen Adapter, a physical device that attaches to insulin pens to capture and transmit dosing data. It is not described as an AI/ML device.
• Performance Data (Section 13): This section outlines "Bench testing on performance" for the physical adapter, including:
  • Dose accuracy of pen not affected by SoloSmart®.
  • Recording and transmission Accuracy.
  • Dose Prime Differentiation.
  • Complete Dose Notification.
  • Incomplete Injection Identification.
  • Physical Interaction with pen.
• Other Testing: Biocompatibility, Lifetime, Electrical safety, EMC and Radiocommunication, Cybersecurity Testing and Software Verification and Validation. These are standard tests for medical devices, not specific to AI/ML performance.
• Human Factor Validation (Section 14): Confirms usability of the device form factor and instructions for use.
• Substantial Equivalence (Section 8 & 12): The core of the 510(k) submission is to demonstrate that the SoloSmart® is substantially equivalent to a legally marketed predicate device (Mallya Injection Pen Adapter). This comparison focuses on indications for use, intended use, fundamental scientific technology, and technological characteristics (e.g., Bluetooth Low Energy communication, mechanism for recording dose).

In summary, the provided text does not describe an AI/ML-based medical device or any studies related to its AI performance. Thus, it is impossible to extract the requested information regarding AI acceptance criteria and proof of meeting those criteria.

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Solon is intended to be use in dermatology, cosmetic surgery, and other surgical applications according to the different handpieces.
The specific indications should reference to the indications of each handpiece.

1. Pro handpiece:
   · Incision, excision, ablation, vaporization of soft tissue
   · The non-ablative treatment of facial wrinkles
2. Multistation Handpiece:
   · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.
3. Vektra QS Handpiece:
   · Tattoo Removal: Dark Ink: (Black & Blue)
   · Nevus of Ota
   · Skin resurfacing procedures for the treatment of acne scars and wrinkles
4. IPL Handpiece:
   The Intense Pulsed Light wavelengths are 515-1200 nm
   · Multiwave: 650-1200 nm
   The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicules.
   · Expert Light: 570- 1200nm
   The treatment of benign pigment (epidermal and cutaneous) lesions, such as warts.
   · Expert Light: 515-1200nm
   The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal anf leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations.

The Solon system is a modular multifunction device. The equipment can be used in dermatology, and aesthetic surgery according to the different handpieces. The Solon system has five laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd:YAG Laser, and two IPL handpiece.

The provided text is a 510(k) summary for the medical device "Solon," a modular multifunction laser system. It outlines the device's technical specifications, indications for use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (APOLLO V+ Medical Platform K113018) by comparing technological characteristics, safety standards compliance, and performance parameters. The performance evaluation is based on adherence to recognized international regulations and standards, rather than a clinical performance study with defined acceptance criteria and statistical outcomes.

Therefore, many of the requested information points cannot be extracted from this document, as they pertain to clinical performance studies, which were explicitly stated as not performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through technical and safety comparisons, not through meeting specific performance criteria from a clinical study.

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. No clinical test set data is presented as "No clinical trial was performed."

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 clinical trial was performed, so there was no test set requiring expert ground truth.

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

Not applicable. No clinical trial was performed.

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 device is a laser surgical instrument, not an AI-assisted diagnostic tool. Furthermore, "No clinical trial was performed."

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

Not applicable. This device is a physical laser system, not an algorithm. "No clinical trial was performed."

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

Not applicable. No clinical trial was performed.

8. The sample size for the training set:

Not applicable. No clinical trial was performed.

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

Not applicable. No clinical trial was performed.

Information that is available (related to the overall submission):

• Device name: Solon
• Regulation number: 21 CFR 878.4810
• Regulation name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX
• Predicate Device: APOLLO V+ Medical Platform (K113018) from Beijing Syntech Laser Co., Ltd.
• Indications for Use: Detailed for various handpieces including incision/excision/ablation/vaporization of soft tissue, non-ablative treatment of facial wrinkles, unwanted hair removal, tattoo removal, treatment of Nevus of Ota, skin resurfacing for acne scars and wrinkles, and treatment of benign pigment/vascular lesions.
• Safety Standards Compliance (Non-clinical testing performed against these standards):
  • IEC 60601-1:2005 +CORR.1:2006 +CORR.2:2007+A1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic disturbances)
  • IEC 60601-2-22 Edition 3.1 2012-10 (Particular requirements for laser equipment)
  • ISO 10993-1: 2018 (Biological evaluation of medical devices - risk management)
  • ISO 10993-5: 2009/(R)2014 (Biological Evaluation of Medical Devices - Tests for In vitro Cytotoxicity)
  • ISO 10993-10: 2010/(R)2014 (Biological Evaluation of Medical Device - Tests for Irritation and Skin Sensitization)
• Non-clinical Testing: The submission explicitly states, "No clinical trial was performed." The safety and effectiveness are "Based on compliance with the international standard and regulation mentioned above," demonstrating equivalence to the predicates.

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SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.

SOLO-L is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

SOLO-L is an anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion. The SOLO-L constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. The cages include a central graft window which may be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft prior to implantation. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. SOLO-L is made from titanium alloy (Ti-6Al-4V ELI). An optional interbody component composed of polyetheretherketone (PEEK) with tantalum markers is available for modular cages.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) clearance letter for a medical device called SOLO-L, an intervertebral body fusion device.

The document states:

• "No additional non-clinical testing was provided to demonstrate substantial equivalence."
• "No clinical data were provided in order to demonstrate substantial equivalence."

This indicates that no new studies were conducted by Aurora Spine Inc. to demonstrate the performance of the SOLO-L device against specific acceptance criteria. The clearance was based on the device having identical technological characteristics (design, dimensions, materials, and manufacturing processes) to a previously cleared predicate device (A-Link Z, K201671).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location.

The SOLOPASS® System consists of three main sub-systems:

1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide.
2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient.
3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal.

The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth.

The provided text describes the SOLOPASS® System, a neuronavigational system that collects intraoperative ultrasound imaging and positional data to aid in the frontal placement of an intra-ventricular catheter. The document details the device's comparison to a predicate device and summarizes non-clinical testing performed to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The document primarily focuses on two key performance metrics related to accuracy: "System Targeting Accuracy" and "System Imaging Accuracy."

Additionally, other acceptance criteria are implicitly met by passing various tests:

• Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, negative for acute systemic toxicity, bacterial endotoxins < 2.15 Eu/device.
• Thermal, Electrical, Mechanical Safety: Pass IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIM 7351731, IEC/EN 60529 (IPX7).
• Cleaning, Disinfection, Sterilization: Pass validation for cleaning and VHP sterilization of Ultrasound Probe (SAL 10^-6), and gamma sterilization of single-use PID (SAL 10^-6).
• Ship and Shelf Life Functional Test: Pass ISTA 3A, ISO 11607-1, and shelf-life aging (PID shelf life: 12 months).
• 2D Imaging Qualification: Pass verification of ultrasound requirements (imaging depth, image accuracy, active element check, and other specifications).
• Cranial Mounting Mechanical Testing: Met acceptance criteria for mean pullout strength of anchor and mean ratio of yield strength vs. insertion torque.
• Hardware Verification: Pass verification of system electrical design requirements.
• Software Verification and Validation: Pass, demonstrating that all software requirements were appropriately implemented and conformity to IEC 62304.
• Design Validation Study: Pass, user needs were successfully validated.

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

The provided text does not explicitly state the numerical sample size for the test set for each specific performance test (e.g., how many measurements were taken for targeting accuracy, or how many units were tested for biocompatibility). The studies are listed as "Nonclinical Testing," "Verification Bench Testing," and "Design Validation," which typically imply controlled laboratory or simulated environments rather than patient data.

• Data Provenance: The studies are "Nonclinical" and "Bench Testing," suggesting they are laboratory or simulation-based rather than patient data. There is no information provided about the country of origin or whether data was retrospective or prospective.

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):

The document does not mention the involvement of experts in establishing the "ground truth" for the non-clinical and bench testing. These types of tests typically rely on highly controlled physical setups and precise measurement tools to establish ground truth, rather than human interpretation.

For the Design Validation Study, "user needs were successfully validated." While this implies user involvement, the number and qualifications of "users" (presumably clinicians or surgeons) are not specified.

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

Not applicable. For non-clinical bench testing, adjudication methods for human interpretation are not typically used. The results are quantitative measurements against predefined criteria.

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

No, an MRMC comparative effectiveness study was not done. The document describes a medical device for surgical guidance, not an AI/CAD system intended to assist human readers in image interpretation or diagnosis. The focus is on the device's accuracy and safety as a tool in a surgical setting.

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

The performance metrics like "System Targeting Accuracy" and "System Imaging Accuracy" are inherently standalone performances of the device's capabilities, measured in a controlled environment. The device provides "intra-procedural, image guided localization and navigation," which implies it provides data for human users, but the accuracy metrics presented are for the device's output itself.

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

For the accuracy metrics, the ground truth was established through physical measurements against known standards or reference points in controlled bench test environments. This is typical for navigations systems where accuracy is quantitatively measured directly. The document states:

• "System Targeting Accuracy: Measure targeting accuracy. Acceptance criteria defined based on Reference Device, V-Guide for Ventriculostomies (K141559)."
• "System Imaging Accuracy: Measure imaging accuracy."

This indicates that ground truth was derived from precisely measured physical setups and comparison to a known reference.

8. The sample size for the training set:

Not applicable. The SOLOPASS® System is described as a medical device for navigation and imaging, not as an AI or machine learning system that requires a "training set" in the context of model development. The software component mentioned (and verified against IEC 62304) is for operating the device and processing the imaging/positional data, not for learning from a dataset to perform interpretations or predictions.

9. How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for an AI/ML model.

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The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.

The Solo™ / Swing Maxi™ breast pumps are intended for a single user.

The breast pumps are intended to be used in a home environment.

Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile.

The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).

The Solo"M and Swing Maxi™ breast pumps feature 2-Phase Expression® technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features:

• user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
• a port for connection of the tubing that channels the vacuum for breast pumping;
• a port for connection of the power supply;
• a central LED light as status indicator; and
• a textile lanyard as an interface to the user's clothes/body.

The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression.

Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.

The provided document is a 510(k) premarket notification for the Medela Solo™ / Swing Maxi™ breast pumps. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states that the breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. It also lists performance data provided to support the substantial equivalence determination. These performance data are:

• Electrical Safety testing: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-11:2015.
• Risk analysis: In accordance with ISO 14971:2007.
• Electromagnetic compatibility testing: In accordance with IEC 60601-1-2:2014.
• Biocompatibility evaluation: Completed according to FDA guidance "Use of International Standard ISO 10993-1," concluding no new testing was required as patient-contacting materials are identical to the predicate device.
• Software validation: In accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The software was considered a "Moderate" level of concern.
• Bench testing: Conducted to determine minimum and maximum vacuum levels and cycle rates compared to specifications.
• Battery and pump use life testing: Conducted to demonstrate device maintenance of specifications throughout its use life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met for an AI/ML device because the provided text is for a traditional medical device (breast pump) and does not describe an AI/ML component or associated performance studies against specific AI/ML metrics.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the information you need.

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