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UE BRONCHO Single-Use Bronchoscope: The UE BRONCHO Single-Use Bronchoscopes has been designed to be used with the UE Display, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The UE BRONCHO Single-Use Bronchoscopes is for use in a hospital environment. The UE BRONCHO Single-Use Bronchoscopes is single-use device designed for use in adults.

UE Display: The UE Display is reusable digital monitor, intended to display live imaging data from UE Medical visualization devices.

The bronchoscope system consists of UE BRONCHO Single-Use Bronchoscopes and UE Display. The UE BRONCHO Single-Use Bronchoscopes (the bronchoscopes) are sterile, single-use flexible video bronchoscopes available in three sizes (Slim, Regular, Large). The bronchoscopes have been designed to be used with the UE Display (reusable, non-sterile), endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The bronchoscope system is designed for use by adults in a hospital environment.

The provided FDA 510(k) clearance letter details the clearance of the UE BRONCHO Single-Use Bronchoscopes and UE Display. However, it does not contain specific acceptance criteria or details of a clinical study that demonstrates the device's performance against such criteria. The document explicitly states "Clinical study: Not applicable."

The clearance is based on non-clinical data, specifically performance testing and compliance with voluntary standards, which demonstrates substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho, Ambu® aView™ Monitor - K173727).

Therefore, I cannot populate the requested table and answer questions 2-9 with the provided text. The document refers to "bench performance testing" which includes optical performance, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range, and frame rate, comparing these aspects with the predicate device. However, it does not specify quantitative acceptance criteria for these tests nor provide the reported device performance against such criteria in the detail requested.

Here's an attempt to populate the table and address the questions based only on the information available in the provided text. Where information is missing, it will be stated as "Not provided in the text."

1. Table of Acceptance Criteria and Reported Device Performance

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

Not provided in the text. The document refers to "bench performance testing" which typically uses a limited number of physical units or simulated conditions, rather than a "test set" of patient data as might be relevant for AI/ML devices. No human patient data was used for testing.

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

Not applicable, as no clinical study or expert-based ground truth establishment for a test set is mentioned. The testing was non-clinical bench testing.

4. Adjudication method for the test set

Not applicable, as no clinical study involving expert interpretation or adjudication is mentioned.

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. The document explicitly states "Clinical study: Not applicable." Therefore, an MRMC study was not performed. This device is a bronchoscope system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a bronchoscope system. While it has software and display capabilities, it is not an algorithm that performs a diagnostic or analytical function independently of a human operator, and no standalone performance study in this context was mentioned.

7. The type of ground truth used

For the non-clinical bench tests (e.g., optical performance, physical dimensions, electrical safety), the "ground truth" would be established by direct physical measurements, adherence to engineering specifications, and compliance with recognized international standards (e.g., ISO 8600, IEC 60601 series, ISO 10993 series). There is no "ground truth" in the clinical sense (e.g., pathology, outcomes data, expert consensus) as no clinical studies were performed.

8. The sample size for the training set

Not applicable. This device is a bronchoscope system and not an AI/ML device that requires a training set of data for model development.

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

Not applicable, as no training set was used.

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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Cure Catheter Insertion Kit" and related products. It outlines the regulatory classification, intended use, and a comparison to a predicate device.

However, it does not contain information about specific acceptance criteria or a study that objectively proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or screening device.

The "Performance Data" section lists various validation tests for general device characteristics, such as:

• Sterilization validation: Conforms to AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019.
• Biocompatibility testing: Conforms to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1".
• Sterile packaging: Conforms to ISO 11607-1:2019 and ISO 11607-2:2019.
• Real-time aged shelf-life testing: Conforms to ISO 11607-1:2006 with justification to version 2019.
• Packaging integrity testing: Conforms to ASTM F2096-11 (2019).
• Urinary catheter testing: Conforms to ISO 20696:2018.

These are standard engineering and safety tests for medical devices, ensuring they are safe, sterile, and perform their basic mechanical function. They are not clinical performance studies to assess diagnostic accuracy or the direct clinical efficacy of a software-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity), study design details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), is not available in this 510(k) clearance letter.

This document is for a urological catheter and accessories, which are physical medical devices, not an AI or software-based diagnostic tool. The performance data listed refers to the manufacturing, material, and sterility aspects, which are crucial for this type of device, but do not involve the types of criteria and studies you've asked about for AI/diagnostic devices.

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The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.

Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.

The !M1 mobile X-ray system is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The !M1 system incorporates a flat-panel detector(s) that can be used wirelessly for exams such as in-bed projections. The system can also be used to expose CR phosphor screens or film.

The provided FDA 510(k) clearance letter and documentation describe a submission for an updated mobile X-ray system, !M1. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria for an AI/algorithm-based medical device.

The clearance is for a mobile X-ray system and its components (generators, X-ray tubes, collimators, and new lines of digital detectors and associated imaging software), not an AI algorithm for diagnostic interpretation that would typically have specific performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested items related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training/test sets, training set sample size) are not applicable or not provided in this type of 510(k) submission for an imaging device itself. The "performance" being improved here refers to the image acquisition capabilities (DQE, MTF, pixel size, kV, mAs, kW) of the new hardware components, not the output of a diagnostic AI algorithm.

Based on the provided document, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely implied by demonstrating that the new components (collimator, generator, X-ray tube, software, and detectors) either maintain or improve upon the technical specifications and image quality parameters of the predicate device, while maintaining the same Indications for Use. The "study" proving this largely relies on non-clinical testing and compliance with relevant performance standards for X-ray equipment and image quality.

Study Details (As applicable to an X-ray System 510(k))

1. Sample size used for the test set and the data provenance:
   This 510(k) is for an X-ray imaging system and its components, not a diagnostic AI algorithm. Therefore, there isn't a "test set" of patient cases in the context of an AI study.

   • Test Data: The testing involves non-clinical verification and validation of hardware performance (e.g., kV, mAs, kW measurements, image quality metrics like DQE, MTF, and spatial resolution using phantoms or test targets) and software functionality.
   • Provenance: Not explicitly stated, implied to be internal testing by the manufacturers (Solutions for tomorrow AB, Konica Minolta, Canon Inc., Vieworks Co., Ltd) in their development and quality assurance processes. This is typical for device component integration.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A). Ground truth in this context refers to the measured physical properties and image quality metrics of the X-ray system components, not clinical diagnoses made by experts. For example, DQE and MTF are measured using standardized methods and phantoms, not adjudicated by clinical experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   N/A. This is relevant for clinical studies where human readers establish ground truth for diagnostic AI. Here, performance is verified through engineering and physics measurements.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   N/A. This is not an AI diagnostic assistance device. It's an X-ray imaging system.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   N/A. Not an AI diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the components of the X-ray system, the "ground truth" consists of physical measurements and standardized tests of parameters such as:

   • Output of the X-ray generator (kV, mAs, kW).
   • Image quality metrics of the detectors (DQE, MTF, pixel size, spatial resolution) measured using phantoms and established procedures (e.g., IEC standards).
   • Functionality of the collimator.
   • Compliance with electrical and radiation safety standards (EN 60601 series).

7. The sample size for the training set:
   N/A. The document does not describe an AI algorithm that requires a "training set" of patient data in the conventional sense. The "software" mentioned is operational imaging software, not a deep learning model for image interpretation.

8. How the ground truth for the training set was established:
   N/A. See point 7.

In summary, the provided document details a 510(k) submission for an updated mobile X-ray system and its components. The "acceptance criteria" and "proof" relate to meeting the performance specifications for hardware and integrated software functionality, and compliance with medical device standards, rather than the diagnostic performance of an AI algorithm.

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Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.

Philips Reusable ECG Lead Sets and Trunk Cables are non-invasive reusable medical devices designed to transfer ECG signals from the patient to the monitor used in the healthcare facilities, which includes intensive care unit (ICU) for both adults and neonates and the operating room (OR). The ECG cables and lead sets are used to forward an electrical cardiac signal via electrical wires from the electrode attached on patient skin to the ECG measurement hardware in the patient monitor and to support other outputs as needed. The portfolio consists of two types of trunk cables and two types of lead sets: ICU and OR, including various electrode connectors with AAMI and IEC coloring. The ECG Trunk cables and lead sets are suitable for multiple patient use. The Philips Reusable ECG Lead Sets and Trunk Cables have a service life of 18 months. The Philips Reusable ECG Lead Sets and Trunk Cables can be used with any Philips monitors including Philips monitor/defibrillator product lines and Philips monitoring or diagnostic equipment which claim compatibility to Philips Reusable ECG Lead Sets and Trunk Cables.

This document is a 510(k) premarket notification for Philips Reusable ECG Lead Sets and Trunk Cables. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with clinical accuracy metrics. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth are not applicable or explicitly stated in this type of submission.

However, I can extract the information that is present regarding performance testing and standards.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific quantitative clinical acceptance criteria and device performance metrics, this submission relies on compliance with recognized harmonized standards. The "performance" is demonstrated through successful completion of tests outlined in these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document explicitly states: "The subject devices, like the primary predicate devices, did not require clinical trials." Therefore, there is no "test set" in the context of a clinical study for external validation of performance. Performance is primarily demonstrated through compliance with recognized standards via non-clinical bench testing. The data provenance would be from internal lab testing, not patient data.

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 test set requiring expert ground truth was used as per the statement above.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.

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 an ECG cable and lead set, a hardware accessory. It is not an AI algorithm for interpreting medical images or signals, nor does it involve "human readers" or "AI assistance" in that sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware accessory, not an algorithm. Performance is assessed through its physical and electrical properties, not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth. For non-clinical bench testing, the "ground truth" would be established by the specifications and measurement techniques defined within the harmonized standards (e.g., electrical resistance, mechanical durability measured against stated tolerances, biocompatibility testing results).

8. The sample size for the training set
Not applicable. This is a hardware accessory, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set.

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Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text describes a 510(k) premarket notification for a Wearable Breast Pump and does not include information about a study that proves the device meets specific acceptance criteria for AI/ML performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for AI/ML.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document mentions "Software" and states it was "evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document 'Content of Premarket Submissions for Device Software Functions.'" This level of documentation suggests that the software in question is likely not an AI/ML algorithm that requires rigorous clinical validation with ground truth for diagnostic or prognostic purposes, but rather controls basic device functions (e.g., suction settings, modes, battery indicators).

The performance testing listed in Section 9 ("Summary of Non-Clinical Performance Testing") includes:

• Vacuum level verification testing
• Backflow protection testing
• Use life testing
• Battery performance testing
• Battery status indicator testing

These are standard engineering and safety tests for a powered breast pump, not the type of studies typically conducted to evaluate AI/ML performance against acceptance criteria for a diagnostic or decision-support system.

In summary, the provided FDA 510(k) clearance letter and summary do not contain information related to AI/ML device performance or the study details requested in your prompt.

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(1) IPL: The Therapy IPL is intended for medical use in the following dermatologic conditions: Permanent hair reduction- long-terms table reduction in number of hairs re-growing after a treatment - Moderate inflammatory acne vulgaris; - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

(2) Diode laser: Diode laser treatment handset is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin type I-VI), including tanned skin. 3) Triple Diode laser: The device is intended for use in dermatologic and general surgical procedures.

The Triple diode laser Module is intended for use in dermatology procedures requiring coagulation. The Triple diode laser Module is indicated for: - Benign vascular and vascular dependent lesions removal.

(4) Picosecond Nd: Y AG Laser: The Picosecond Nd: Y AG Laser is intended for use in surgical and aestheir applications in the medical specialties of dermatology and general and plastic surgery. - The 1064nm wavelength of the Picosecond Nd:YAG Laser is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). - The 532mm wavelength of the Picosecond Nd: Y AG Laser is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types 1-III.

(5) 1064nm Long pulse Nd: YAG: The 1064nm Long pulse Nd: YAG is indicated for - Benign vascular lesions. - Superficial and deep telangiectasias). - Benign cutaneous lesions. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - The non-ablative treatment of facial wrinkles. - Laser skin resurfacing procedures. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. - Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. - Removal or lightening of unwanted hair (with and without adjuvant preparation). - Treatment of pseudofolliculitis barbae (PFB).

(6) Q-switch Nd:YAG laser: The Q-switch Nd:YAG Laseris Module indicated for: -Benign vascular and pigmented lesions, age spots. - Nevus spilus. - Tattoo removal.

The BL-M10 is a new platform treatment system with 12.1" display screen which combines IPL/ Diode Laser/Triple Diode Laser/ Picosecond Nd:YAG Laser/ 1064nm Long pulse Nd:YAG laser and Q-switch Nd:YAG Laser functions. This is 6 in 1 platform machine, that provides different function with attaching different hand pieces. The system is designed with a mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolative and non-ablative treatment of skin surface. The system includes various energy sources and dedicated hand-pieces intended to apply the different energies to the skin for respective indications for use.

This device is a Multi-function Platform System (BL-M10) which includes IPL, Diode laser, Triple Diode laser, Picosecond Nd:YAG Laser, 1064nm Long pulse Nd:YAG, and Q-switch Nd:YAG laser functions. The acceptance criteria and supporting studies are presented through a substantial equivalence discussion with multiple predicate devices for each function.

A general acceptance criterion for all functions is that the differences between the subject device and the predicate device should not raise new concerns regarding intended use or safety.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by showing substantial equivalence to existing predicate devices. The reported device performance is demonstrated by comparing its features with those of the predicate devices. Since there are multiple functions and predicates, a combined table is challenging without further clarification of "acceptance criteria" beyond substantial equivalence. However, the document outlines feature-by-feature comparisons for each function, highlighting similarities and differences.

Let's extract a representative sample for the IPL function from "Tabel 1 Substantial equivalence discussion - IPL":

Similar tables are provided for Diode Laser, Triple Diode laser, Picosecond Nd:YAG Laser, 1064nm Long pulse Nd:YAG, and Q-switch Nd:YAG Laser functions.
The overall acceptance criterion is that any identified differences do not raise concerns regarding the intended use or safety of the subject device, which is concluded to be met for all functions.

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

The document states "VII.1. Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification." and "VII.2. Performance Testing: Each handpiece underwent rigorous performance testing to verify adherence to specified energy output, wavelength accuracy, pulse duration, and spot size."
No specific sample size for a "test set" (e.g., number of devices or units tested) is provided. The testing is non-clinical.
Data provenance: The tests were conducted internally by Shanghai Bele Medical Technology Co., Ltd. for verification and compliance with standards. It is non-clinical testing.

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

Not applicable. The document describes non-clinical testing for safety and performance characteristics, comparing technical specifications to predicate devices and recognized standards. It does not involve a "test set" requiring expert-established ground truth for diagnostic accuracy, for example.

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

Not applicable. This section is for clinical studies involving human observers and diagnostic ground truth adjudication, which is not described.

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

Not applicable. This device is a laser/light treatment system, not an AI-powered diagnostic imaging device that assists human readers. No MRMC study was performed.

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

Not applicable. This device is a medical instrument used by practitioners, not a standalone algorithm.

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

For non-clinical testing, the "ground truth" for performance is based on engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62471), and direct measurement of physical parameters like energy output, wavelength, pulse duration, and spot size. For safety, the ground truth is compliance with the relevant safety standards.

8. The sample size for the training set

Not applicable. This submission describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not a machine learning device.

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The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.

The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.

The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.

The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.

All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.

The provided document is a 510(k) summary for the Midmark Smart M9® and Smart M11® Sterilizers. It details the device's characteristics and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on its ability to perform sterilization effectively and safely according to established standards. The reported device performance is indicated by its compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document states that non-clinical evaluations were performed for the Midmark Smart M9® and Smart M11® Sterilizer. The purpose of these evaluations was to demonstrate compliance with recognized standards for safety and performance, thereby proving substantial equivalence to a legally marketed predicate device.

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

   • The document does not specify a sample size for the test set (e.g., number of sterilization cycles tested, number of units tested).
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it concerns a medical device seeking FDA clearance, it's implied that the testing was conducted under controlled conditions to regulatory standards.

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

   • This information is not applicable to this type of device and study. The ground truth for a sterilizer is established through physical and biological indicators demonstrating the elimination of microorganisms, not through expert consensus on image interpretation or diagnosis. The "experts" implicit in this context are the testing laboratories and their personnel following the specified scientific and engineering standards.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For device performance testing against engineering standards, the results are objective measurements (e.g., temperature, pressure, biological indicator kill) that either pass or fail the predefined criteria.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI/CAD systems that assist human readers. The Midmark Smart M9® and Smart M11® Sterilizers are steam sterilizers, and their performance is evaluated directly against physical, chemical, and biological sterilization parameters, not through human interpretation of cases.

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

   • This question is not applicable in the conventional sense of AI/algorithm performance. The device is a physical sterilizer with automated cycles. Its "performance" is inherently "standalone" in that it performs its function without human intervention during the sterilization cycle once initiated. The evaluations listed are standalone device performance tests.

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

   • The ground truth for a sterilizer's performance is objectively defined by the complete kill of specific biological indicators (e.g., bacterial spores known to be highly resistant to sterilization processes) under specified conditions (temperature, pressure, time). It also includes measured physical parameters (e.g., temperature and pressure profiles over time) matching the standards, and the successful completion of cycles without errors. This is a scientific and engineering ground truth, not based on human consensus or pathology from patient outcomes.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning or AI. This device is a traditional medical device (steam sterilizer), not a deep learning or AI-based diagnostic tool that requires a training set. The design and validation of the sterilizer are based on established engineering principles and extensive physical and biological testing.

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

   • This question is not applicable as there is no mention of a training set for an AI/ML algorithm.

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755mm:

The Elite iQ PRO Laser System is indicated for stable long-term or permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1064nm:

The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and porkiloderma of Civatte; and treatment of beingn cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the treatment of pseudo follicultis barbae (PFB) and for stable long-term or permanent hair reduction. 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 the completion of a treatment regime.

The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Elite iQ™ PRO workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ PRO delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ PRO also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin.

The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser.

Elite iQ PRO software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. The software of the device was changed to update the fluence levels for the handpieces in order to support the new 30mm handpiece. The new 30 mm handpiece is also part of the DEKA AGAIN PRO device (K233090). The new fluence levels are within range of the previously approved ranges in the Elite iQ device (K193426). The software was also updated to reflect the Elite iQ PRO branding.

There are no changes to the principle of use of the device compared to the predicates Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090).

The labeling of the device has been updated to reflect the name of the device Elite IQ PRO Laser System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elite iQ PRO (M122K1) device.

Key Observation: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices (Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090)) through comparison of technical characteristics and intended uses. It does not contain details about a clinical study with acceptance criteria for device performance in terms of efficacy or diagnostic accuracy (e.g., sensitivity, specificity, accuracy) for its intended indications (hair reduction, vascular lesions, etc.).

Instead, the "acceptance criteria" and "study" described are in the context of verification and validation activities against recognized electrical and laser safety standards, and comparing technical specifications to predicate devices.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" appear to be compliance with established safety and performance standards for medical electrical and laser equipment, as well as maintaining similar technical characteristics to predicate devices. The "reported device performance" is implicitly that the device meets these standards and maintains comparable technical specifications.

Note: The document explicitly states: "The following verification and validation activities have been performed on the modified device." This indicates that the studies performed were primarily focused on demonstrating compliance with these technical and safety standards, rather than clinical efficacy.

Regarding Device Performance (from comparison tables):

The device's performance is described in terms of its technical specifications, which are compared to predicate devices. The key updates for the Elite iQ PRO are:

• Repetition Rate: Up to 12 Hz (compared to 10 Hz for Elite iQ and 12 Hz for DEKA AGAIN PRO).
• Handpiece (Spot) Size: Addition of a 30mm handpiece, similar to DEKA AGAIN PRO (Elite iQ had up to 24mm).
• Software update to reflect new fluence levels for the 30mm handpiece and Elite iQ PRO branding.

These are considered performance improvements or equivalences rather than demonstrating achievement of specific clinical acceptance criteria through a trial.

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 mention a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The studies appear to be technical verification and validation, not clinical trials on patients.

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

This information is not provided in the document. As no clinical efficacy or diagnostic accuracy study is described, there's no mention of experts establishing ground truth for a patient test set.

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

This information is not provided, as the document does not describe a clinical test set requiring 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

There is no mention of an MRMC comparative effectiveness study, nor any AI assistance/human-in-the-loop performance data. The device is a laser system and a melanin reader; it does not appear to incorporate AI for interpretation or diagnosis that would necessitate such a study.

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

This is not applicable as the device is a laser system and a melanin reader, not an AI algorithm performing diagnostic tasks.

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

Since the studies described are for technical verification and validation against standards, the "ground truth" would be the specifications and requirements of those engineering and safety standards. For the Skintel Melanin Reader accuracy, the ground truth would be established by reference measurements or calibrated instruments. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the efficacy of hair removal or lesion treatment.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML device that requires a training set in the conventional sense.

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

This is not applicable for the same reason as above.

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The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.

Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).

Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.

The document explicitly states:
"8. Clinical Studies Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.

The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:

1. Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
2. Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
3. Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
4. Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
5. Acoustic Output: The acoustic output is below the FDA limits (Ispta.3

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The Medaica M1 Telehealth Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Medica M1 Telehealth Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

The Medaica M1 Telehealth Stethoscope is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables three types of stethoscope exams: Heart. Lungs and Audio (Audio is for clinician only). The operation process of the Medaica M1 Telehealth Stethoscope uses four (4) primary functional elements:

• (1) The Medaica M1 Telehealth Stethoscope.
• (2) A patient's web-connected computer on which the Medaica Web Client software is running.
• (3) The Medaica Server on which the Medaica server software is running.
• (4) A clinician's web-connected computer on which the Medaica Web Client software is running.
  The Medaica M1 Telehealth Stethoscope operates either in Patient Store and Forward mode or Live, online mode. Both modes are essentially similar and share the same fundamental steps: performing one or more exams using the Medaica M1 Telehealth Stethoscope, recording the data and sending to a clinician, review of the exams by the clinician, and the user receiving a summary from the clinician presenting his/her assessment and/or recommendations. While in the Patient Store and Forward mode, the Patient can send the recorded data to the clinician whenever convenient for him/her. A Live, online mode can only be executed when the clinician is available online at the same time as the patient.

The provided text does not contain detailed acceptance criteria and a study dedicated to proving the device meets those specific criteria in the way a clinical performance study for an AI-powered diagnostic device might.

However, based on the Performance Testing section, we can infer some general performance criteria and how they were met:

Here's an attempt to answer your questions based on the available information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic performance (e.g., patient cases for diagnostic accuracy). The performance testing refers to engineering and regulatory compliance tests. Therefore, there's no information on sample size or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document outlines performance testing for device functionality, safety, and regulatory compliance, not for diagnostic accuracy evaluated by experts against a ground truth.

4. Adjudication method for the test set
Not applicable, as no diagnostic test set with ground truth established by experts is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Medaica M1 Telehealth Stethoscope is described as an electronic stethoscope for transmitting auscultation sounds. The document does not indicate that it incorporates AI for diagnostic assistance to human readers. Its primary function is data transmission and sound capture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a stethoscope used by either a lay user or a clinician, with sound data interpreted by a clinician. It's not an AI algorithm performing standalone diagnoses.

7. The type of ground truth used
For the "Stethoscope performance testing" mentioned, the ground truth would likely be established by objective physical measurements (e.g., using calibrated sound sources and measurement equipment) to verify sensitivity, signal-to-noise ratio, and frequency response against established engineering specifications for stethoscopes. For "Biocompatibility" and "Electrical safety & EMC," ground truth is adherence to the specified international standards.

8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set in the machine learning sense.

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

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