Search Results

• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece.
The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable.
The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized.
The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.
The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.

The provided text is a 510(k) summary for the DEKA LOTUS device, which is an intense pulsed light (IPL) and radiofrequency (RF) system. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and validation results for an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within the provided text.

The document states:

• Clinical Performance Data: None. This explicitly indicates that no clinical studies were performed to prove the device meets acceptance criteria in a clinical setting.
• Non-Clinical Performance Data: "Test according to IEC 60601-2-57:2011 for the modified IPL Handpiece." This refers to electrical safety and electromagnetic compatibility standards, not performance criteria for a specific medical outcome or AI algorithm.

The core of this 510(k) submission is a comparison of the device's technical specifications and intended use against a predicate device (Quanta Chrome K202503 and existing DEKA LOTUS K233473) to establish substantial equivalence. The "Acceptance Criteria" here are implicitly linked to demonstrating that the new device variant (specifically, a 570nm filter change for an IPL handpiece) is as safe and effective as the predicate, based on technical similarity, without requiring new clinical performance studies.

Ask a specific question about this device

The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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

The Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), GENESIS (1-74 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).

Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.

The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device. This document focuses on establishing substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new device's performance.

Therefore, the sections below requiring information about acceptance criteria and a study proving the device meets them cannot be fully populated as they would for a de novo or PMA submission. The document primarily discusses non-clinical tests to verify design specifications and compliance with standards.

Here's the information that can be extracted or inferred from the provided text, with clarifications where details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of explicit acceptance criteria with corresponding device performance metrics for efficacy (e.g., specific hair reduction percentages) as would be found in a clinical study report for a new device.

Instead, the document focuses on demonstrating that the device meets safety and performance standards and is technologically equivalent to its predicate. The "performance" discussed primarily relates to meeting design specifications and regulatory standards.

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

The document primarily refers to non-clinical tests for compliance with standards and design specifications. It does not describe a clinical test set with human subjects.

• Test Set Sample Size: Not applicable as a clinical test set is not described. The tests are for device components and system performance.
• Data Provenance: The tests are non-clinical, related to device manufacturing and engineering compliance. No country of origin for clinical data is applicable. The tests are prospective in the sense that they are conducted on the new device to demonstrate compliance.

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

This information is not applicable as the document describes non-clinical engineering and compliance testing, not a clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

Not applicable, as this refers to a clinical study with human observers or interpreters, which is not described here.

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 hair removal system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in a diagnostic context.

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, and the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the requirements outlined in the cited international and national standards (e.g., IEC 60601-1, ISO 10993) and the device's design specifications. These standards provide benchmarks and methodologies against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. As this document details hardware medical devices, there is no "training set" in the context of machine learning or AI.

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

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

Ask a specific question about this device

The Versana Premier/Versana Premier Lotus/LOGIQ F is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Versana Premier/Versana Premier Lotus/LOGIQ F clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and nonvascular access).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

Versana Premier/Versana Premier Lotus/LOGIQ F is intended to be used in a hospital or medical clinic

The Versana Premier, Versana Premier Lotus and LOGIQ F is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing, and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball, and a touch panel with a digital keyboard (physical keyboard as an option) as input sources of the device. The variety of transducers include convex, linear, sector, Bi-plane probe and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal, transcranial and transesophageal. The Versana Premier, Versana Premier Lotus and LOGIQ F share a common software and hardware platform. There may be different configurations commercially offered, however they are all within the overall design of the product.

The provided text is a 510(k) Summary for a new medical device submission (K242005) for the GE Versana Premier, Versana Premier Lotus, and LOGIQ F ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving that the device meets specific acceptance criteria for performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines a comparison to predicate devices, but no specific performance metrics with acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided, as no clinical study demonstrating performance against acceptance criteria was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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 provided. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Summary of what the document does state regarding meeting requirements:

The document states:

• "The subject of this premarket submission, Versana Premier/Versana Premier Lotus/LOGIO F did not require clinical studies to support substantial equivalence." (Page 8)
• It attests to the device's conformance with recognized performance standards and safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).
• It lists several voluntary standards the device complies with (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, NEMA PS 3.1 - 3.20, IEC 62359).
• It outlines quality assurance measures applied during development, including Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, system, performance, safety).

In essence, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with recognized safety and performance standards for ultrasound systems, rather than on a new clinical study with specific acceptance criteria met by the device's performance.

Ask a specific question about this device

· The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

· The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benion pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of benign vascular lesions, including port wine stains, hemangiomas, telangiectasias, rosacea, facial and leg veins.

· The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece. The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable. The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized. The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area.

This document is a 510(k) Summary for the DEKA LOTUS device, which is an intense pulsed light and radiofrequency (RF) system. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria for a novel AI/software component in a diagnostic context.

Therefore, the information required to answer your specific questions about acceptance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies is not present in this document. This is because the DEKA LOTUS is a medical device (pulsed light and RF system), and the 510(k) submission primarily relies on demonstrating equivalence to existing devices through non-clinical performance data (electrical safety, EMC) and comparisons of technical specifications and indications for use, rather than clinical performance studies involving AI algorithms.

Here's a breakdown of why this information is missing and what is provided:

Why the requested information is absent:

• Nature of the Device: The DEKA LOTUS is a physical medical device (laser/light/RF system), not an AI/software-based diagnostic tool. Its performance is assessed through its physical characteristics and safety, not through diagnostic accuracy or interpretation of images/data by an algorithm.
• 510(k) Pathway: The 510(k) substantial equivalence pathway typically does not require extensive clinical trials or performance studies if the device is similar enough to existing ones. It focuses on comparing the new device to predicates in terms of indications for use, technological characteristics, and safety/EMC.
• No AI/Software Component for Interpretation: There's no mention of a software component that interprets medical images, diagnoses conditions, or assists human readers in a diagnostic task. The software validation mentioned refers to the general control software for the device's operation, not an AI for diagnostic purposes.

What information is provided in the document (and how it relates to your questions, or why it doesn't):

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

   • Acceptance Criteria: Not explicitly stated in the context of device performance metrics for an AI. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate devices through identical or similar technical specifications and parameters (e.g., fluence, pulse duration, frequency for light/RF) and demonstrating compliance with safety standards (IEC 60601 series).
   • Reported Device Performance: The document provides comparative tables showing the technical specifications of the DEKA LOTUS against its predicate devices (Quanta Chrome, Palomar Icon, Pollogen Legend+™ System) for pulsed light (590nm, 500G) and RF handpieces. Examples include:
     • Pulsed Light (590nm): Fluence (Up to 25 J/cm² - identical to predicate), Spot Size (20x17 mm vs. predicates' 48x13 mm/25x13mm - difference noted as not affecting safety/effectiveness), Pulse Duration (Up to 40 ms - identical), Repetition Rate (3 Hz max. - identical).
     • Pulsed Light (500G): Fluence (Up to 80 J/cm² - identical), Spot Size (17x20 mm vs. predicate's 10x15 mm - difference noted as not affecting safety/effectiveness), Pulse Duration (1-100 ms - identical).
     • RF Handpiece: Frequency (1 MHz - identical), Waveform (Sinusoidal - identical), Maximum output power (50W or 15W - identical).
   • Safety and EMC testing: The document states that electrical safety and electromagnetic compatibility (EMC) testing were conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2. There were also tests according to IEC 60601-2-57 for non-laser light source equipment. This implies these standards' requirements serve as "acceptance criteria" for basic safety and performance, which were met.

2. Sample sizes used for the test set and the data provenance: Not applicable. This refers to an AI/software's performance test set. The document mentions non-clinical testing (electrical safety, EMC, thermal profiles) but these don't involve test "samples" in the sense of patient data for a diagnostic algorithm. No clinical data or test sets are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to ground truth for diagnostic AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to ground truth for diagnostic AI.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "Clinical Performance Data: None." This type of study (MRMC) is relevant for assessing human reader performance with and without AI assistance, which is not the purpose of this submission for a light/RF device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no diagnostic algorithm to perform in a standalone manner.

7. The type of ground truth used: Not applicable. Ground truth typically refers to validated diagnostic labels for training/testing AI models.

8. The sample size for the training set: Not applicable. There is no AI model being trained on patient data.

9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained on patient data.

In summary, this 510(k) submission for the DEKA LOTUS device demonstrates substantial equivalence based on the device's technical specifications and compliance with relevant safety and performance standards for physical medical devices, rather than a clinical performance study of an AI-powered diagnostic tool.

Ask a specific question about this device

Lotus Single Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

Lotus Double Lumen Ovum Aspiration Needle is used for ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.

The subject devices are single use sterile devices used for ultrasound-guided transvaginal aspiration of oocytes from ovarian follicles.

The Lotus Single Lumen Ovum Aspiration Needle consists of a stainless steel needle with a handle, which is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper is connected to a vacuum tube with a vacuum tubing connector at the other end. The vacuum tubing connector is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The Lotus Single Lumen Ovum Aspiration Needle is 35 cm in length and has device variations from 21 to 16 gauge with aspiration tubing of 600 or 900 mm in length.

The Lotus Double Lumen Ovum Aspiration Needle consists of a stainless steel needle with a Y shaped handle. The Y-shaped handle has two ports: the central port through which oocytes are aspirated via the aspiration lumen, and a secondary side port to allow flushing of follicles via the flushing lumen. The central port is connected to an aspiration tube with a silicone stopper at the other end. The stopper can fit onto a test tube where the oocytes are collected. The stopper has a vacuum connector that is a standard luer lock connector that enables connection to a vacuum pump to provide aspiration suction. The side port is connected to a flushing tube with a flushing connector at the other end, which is a standard luer lock connector that can be connected to a compatible syringe for flushing of follicles. The Lotus Double Lumen Ovum Aspiration Needle is 17 gauge with an aspiration tubing length of 900 mm and with device variations of 30 or 35 mm needle length and flushing tubing of 700 or 1000 mm in length.

This document is an FDA 510(k) Premarket Notification for medical devices, specifically ovum aspiration needles. It does not describe a study involving an AI/Machine Learning device. Therefore, it is not possible to extract information about acceptance criteria or study details relevant to AI/ML device performance from this text.

The document discusses traditional medical device testing, such as:

• Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Irritation.
• Sterilization testing: Ethylene Oxide (EO) sterilization, residual testing.
• Simulated transportation: Adherence to ASTM D4169-22.
• Stability and Shelf Life testing: accelerated aging, package integrity, mechanical performance (appearance, dimensions, needle stiffness, breakage resistance, corrosion resistance, tip penetration force, needle bond strength, flow rate, ultrasound detectability, tubing bond strength, leak, aspiration test, component compatibility).
• Mouse Embryo Assay (MEA): This is a biological test to assess the non-toxicity of materials to embryos, not an AI performance metric. The acceptance criterion for 1-Cell MEA was ≥80% embryos developed to expanded blastocyst at 96 hours after 30 minute exposure.
• Endotoxin evaluation: Acceptance criterion was ≤ 20 EU/device.

Since the request specifically asks for details related to AI/Machine Learning device performance, and this document pertains to a traditional, non-AI medical device, I cannot fulfill the request as stated.

Ask a specific question about this device

The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.

The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].

The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.

The provided text describes the regulatory clearance of a medical device, the LumiMARK™ Biopsy Site Marker, and asserts its substantial equivalence (SE) to a predicate device, the HydroMARK™ Breast Biopsy Site Marker (K212158).

However, the text does not contain information about acceptance criteria, reported device performance in those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

The document focuses on "Performance Testing" and "Biocompatibility Testing" as part of verification data to support substantial equivalence. For both categories, the reported result is "PASSED" and a general statement that "The results of all performance testing met acceptance criteria." However, the specific acceptance criteria themselves, and the quantitative performance metrics attained, are not detailed.

It also explicitly states that the "fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed," and that the "minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness." This suggests that the demonstration of substantial equivalence relies heavily on the similarity to the already cleared predicate device, rather than extensive de novo clinical studies with detailed performance metrics.

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states "Performance Testing was conducted," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not provided. The testing described is primarily bench performance and biocompatibility, not clinical studies requiring expert ground truth establishment in the traditional sense for diagnostic AI tools.

4. Adjudication method for the test set:

• Not applicable/Not provided. No clinical test set requiring adjudication 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:

• No such study was done or mentioned. This device is an implantable biopsy site marker, not an AI-powered diagnostic tool, so MRMC studies for AI assistance are not relevant to its clearance.

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

• Not applicable/Not provided. This device is a physical implantable marker and does not involve an algorithm for standalone performance.

7. The type of ground truth used:

• For "Performance Testing" and "Biocompatibility Testing," the "ground truth" would be established by objective measurements and adherence to specified scientific and engineering standards (e.g., mechanical properties, chemical composition, biological response) rather than expert consensus on medical images or pathology. The text indicates use of standards like ISO 13485, ISO 14971, and ISO 10993 series for these tests.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

• Not applicable/Not provided. (As it's not an AI model, there's no training set or ground truth in this context.)

Ask a specific question about this device

LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).

The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

LOTUS Series 4 Enhanced Shears: The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

LOTUS Series 5: The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.

The provided text describes two medical devices, LOTUS Series 4 Enhanced Shears and LOTUS Series 5, and their substantial equivalence to a predicate device (Lotus Series 4 Ultrasonic Surgical System and Accessories, K151101). The document details the devices' intended use, technological characteristics, and performance testing, but it does not provide traditional acceptance criteria in the form of numerical thresholds or comparative statistics that are typically found in studies for AI/ML devices or diagnostic tools.

Instead, the acceptance criteria are implicitly defined by demonstrating that the new devices are "substantially equivalent" to an existing predicate device, meaning they perform as safely and effectively. The studies conducted are primarily bench testing to confirm this equivalence in performance.

Here's the breakdown based on your request, focusing on what can be extracted from the document:

LOTUS Series 4 Enhanced Shears & LOTUS Series 5

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or effect size) are not provided in this regulatory document, the table reflects the comparison points used to establish substantial equivalence. The "Acceptance Criteria" column indicates that the performance should be "Equivalent to Predicate," meaning it must meet or not negatively deviate from the established performance of the legally marketed predicate device (LOTUS Series 4 Ultrasonic Surgical System and Accessories K151101).

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

• Sample Size: Not explicitly stated as a number of samples in the typical sense (e.g., patient cases). The testing involved bench testing of the devices themselves.
  • For LOTUS Series 4 Enhanced Shears: "Performance testing cut times" and "Transducer lifetime" were tested.
  • For LOTUS Series 5: "Acoustic performance cut times, maximum average power and frequency tracking," "Thermal spread in 3 types of tissue (muscle, kidney and liver)," "Length of dissection," and "Transducer lifetime" were tested.
• Data Provenance: The document only mentions "bench testing" and "No animal testing has been undertaken." This suggests testing performed in a laboratory setting on the physical devices or tissue models, rather than clinical data from specific countries or patient populations. The tests were likely conducted by the manufacturer, SRA Developments Ltd (United Kingdom).

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

• Not Applicable. This submission is for surgical instruments, not for diagnostic or AI/ML devices that require ground truth established by human experts. The performance is assessed through objective engineering and biological bench tests (e.g., cut times, thermal spread in tissue).

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human experts establishing a "ground truth" for diagnostic or AI/ML performance, no adjudication method is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 surgical instrument (ultrasonic shears), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for these devices is established by objective physical measurements and biological effects (e.g., precise timing of cuts, calibrated temperature measurements for thermal spread in animal tissues, mechanical displacement measurements) as compared to the performance of the legally marketed predicate device. It's not expert consensus, pathology, or outcomes data in the typical sense, but rather engineering and pre-clinical performance data.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device

The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.

Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.

The provided text is a 510(k) summary for the Lotus Prophy Angle, a Class I medical device (dental handpiece and accessories). This type of device is a physical tool and does not involve AI, software, or algorithms that would require the creation of a ground truth, training data, or a test set as described in your request. The acceptance criteria and performance studies are focused on physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, many of the requested fields are not applicable to this type of device. I will address the applicable parts of your request based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria (from ANSI/ADA Specification No. 85-1 for Disposable Prophy Angles) | Reported Device Performance |
|------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Speed | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Load | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Temperature Rise | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |
| Vibration Analysis | Performance details not provided. Tested to meet ANSI/ADA Spec No. 85-1 for Disposable Prophy Angles. | Specific quantitative acceptance criterion is not detailed in this document, but implied compliance with ANSI/ADA Spec No. 85-1. |

Study Details (as per document):

The document states: "The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis."

This implies that instead of full, new performance studies demonstrating quantitative measurements, the primary "proof" of meeting acceptance criteria relies on substantial equivalence to a predicate device (ProAngle™ Disposable Prophy Angle, K030603) and confirmatory testing to verify this equivalence.

Based on the provided document, the following points are largely N/A (Not Applicable) or cannot be determined for the reasons explained:

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

• N/A. This device is a physical dental instrument, not an AI/software device that uses data for a "test set" in the context of diagnostic performance. The "testing" mentioned refers to physical performance characteristics. The document does not specify sample sizes for these physical tests or data provenance beyond stating compliance with a standard.

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)

• N/A. This concept is not applicable to a physical dental prophy angle. There is no diagnostic "ground truth" to establish by experts for this type of device.

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

• N/A. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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

• N/A. This is a physical device, not an AI system. MRMC studies are not applicable.

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

• N/A. This is a physical device, not an algorithm.

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

• N/A. As mentioned, "ground truth" as it pertains to diagnostic accuracy is not relevant for a physical dental instrument. The "truth" here is compliance with engineering standard specifications.

8. The sample size for the training set

• N/A. There is no "training set" for a physical device in the AI/machine learning sense.

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

• N/A. See point 8.

Ask a specific question about this device

The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.

The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.

The acceptance criteria and study proving the device meets them are described for the LotusCatheter (Lotus No Balloon Catheter) as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the types of tests conducted but does not present a formal table with specific numerical acceptance criteria and corresponding reported performance values. However, it states that the Lotus No Balloon Catheter passed the modifications of the tests.

The study that proves the device meets the acceptance criteria is described as follows:

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

The document does not specify the exact sample size for each test conducted on the Lotus No Balloon Catheter. However, it indicates that testing was conducted "in accordance with modified performance requirements of its predicate device, the Hakki Urinary Catheter (K101900)." The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

This information is not applicable as the described study involves physical and biological performance testing of a medical device (catheter) against established standards, not interpretation of data by human experts for establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for physical and biological performance testing of a medical device. The tests are designed to objectively measure performance against predefined specifications.

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

This information is not applicable as the LotusCatheter is a physical medical device (urological catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be relevant.

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

This information is not applicable as the LotusCatheter is a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing cited is based on established industry standards and predicate device performance requirements. Specifically:

• ASTM F623-99:2013 (though modified)
• Performance requirements of the predicate device, Hakki Urinary Catheter (K101900)
• ISO 10993 series for biocompatibility (specific parts listed: 10993-5:2009, 10993-10:2010, 10993-11:2010, 10993-11:2017, ISO 10993-6:2016)

8. The Sample Size for the Training Set:

This information is not applicable for physical device performance testing. There is no concept of a "training set" in this context.

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

This information is not applicable for physical device performance testing.

Ask a specific question about this device

The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided text, the device in question is the "LOTUS III Multi-Pulsed Er:YAG Laser System," which is a medical laser system. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria for a new AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI performance metrics like sensitivity, specificity, human reader improvement, ground truth establishment, training sets, etc.) is not present in this type of regulatory submission for this particular device.

This document is for a traditional medical device (a laser system) and primarily relies on non-clinical performance testing and comparison of technical characteristics to predicate devices to establish substantial equivalence. It does not involve a study of the kind typically performed for AI-powered diagnostic devices that would have the specific performance metrics and study design details requested in your prompt.

Here's why the requested information cannot be found in the provided text:

• Device Type: This is a laser system (Er:YAG laser) for general and plastic surgery and dermatology. It is a physical medical device, not an AI/software device that analyzes images or data.
• Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or performance against new, specific clinical acceptance criteria through a full-scale clinical trial like a PMA, or a clinical validation study for an AI algorithm.
• Performance Data (Section 6): The "Performance Data" section explicitly states that "Non-clinical tests" were conducted, referring to compliance with mandatory performance standards for laser products (e.g., 21 CFR 1040.10 and 1040.11), electromagnetic compliance (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), safety of laser products (IEC 60825-1, IEC 60601-2-22), risk management (ISO 14971), and biocompatibility (ISO 10993). These are engineering and safety standards, not clinical performance metrics for a diagnostic AI.
• Absence of Clinical Study Details: There is no mention of:
  • Sensitivity, specificity, AUC, or other diagnostic performance metrics.
  • Test sets, training sets, or data provenance (countries, retrospective/prospective).
  • Experts establishing ground truth, adjudication methods, or MRMC studies.
  • Standalone algorithm performance or human-in-the-loop improvement metrics.

In summary, as this document pertains to a traditional laser medical device obtaining 510(k) clearance, the requested details for AI/imaging device performance criteria and studies are not applicable and thus not present in the provided text.

Ask a specific question about this device