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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.

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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.

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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.

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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.

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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.

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The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Lotus Posterior Cervical/Thoracic Spinal System may be connected to the Mercury® Spinal System with the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury Spinal System. Refer to the Mercury Spinal System package insert for a list of the Mercury Spinal System indications for use.

The Lotus Posterior Cervical/Thoracic Spinal System consists of a variety of fixation devices manufactured from Ti-6Al-4V that are attached to the spine. Screws may be placed from a posterior approach into the cervical and/or thoracic spine. Hooks may be placed on the posterior elements of the various vertebrae. Rods span the distance between the screws/hooks, and various other connectors may be used between rods or between rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

The provided text is a 510(k) premarket notification for a medical device called the "Lotus® Posterior Cervical/Thoracic Spinal System." This document primarily focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets them through clinical or standalone performance studies against a ground truth.

Therefore, many of the requested elements (acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not present in the provided text.

The document discusses performance testing but these are typically mechanical tests to ensure structural integrity and safety, not clinical performance against acceptance criteria for diagnostic or therapeutic efficacy as would be seen in AI or drug approval processes.

Here's a breakdown of what can be extracted and what is missing:

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

• Not found. This document doesn't define clinical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific clinical outcome measure) for the device. The "performance data" mentioned refers to mechanical testing.

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

• Not found. This section is not applicable as there is no test set for clinical performance, only mechanical testing of components.

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 found. This section is not applicable as there is no test set or ground truth established in the context of clinical performance.

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

• Not found. This is not applicable.

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 found. This device is a surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this device.

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

• Not found. This device is a physical surgical implant, not an algorithm.

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

• Not found. Not applicable for this type of device and submission. The "ground truth" for mechanical testing would be the engineering specifications and material properties, against which the physical tests are performed.

8. The sample size for the training set

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

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

• Not found. Not applicable, as this device does not involve a training set for an algorithm.

What is provided regarding "Performance Data":

The document states under "Performance Data":
"Published literature and performance testing support substantial equivalence. Tests included:

• Interconnection testing per ASTM F 1798
• Dynamic Compression Bending per ASTM F 1717
  All data indicates that the device will perform as intended."

Interpretation for your request:

• Acceptance Criteria (Mechanical): The acceptance criteria for these tests would be the specifications outlined in the ASTM F 1798 (Standard Guide for Spinal Implant Material Selection) and ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) standards. These standards define methods for testing the mechanical properties and fatigue life of spinal implant constructs. The device "meets" these acceptance criteria if it passes the specified tests according to the standard's requirements (e.g., withstands certain forces, lasts for a specified number of cycles without failure).
• Reported Device Performance (Mechanical): The document generally states, "All data indicates that the device will perform as intended," implying it met the criteria of the ASTM standards. Specific numerical performance values (e.g., ultimate tensile strength, bending modulus, fatigue life in cycles) are not provided in this summary.
• Study That Proves the Device Meets Acceptance Criteria: The study referred to is the "performance testing" based on the ASTM F 1798 and ASTM F 1717 standards. These are in vitro mechanical engineering studies, not clinical trials.
• Sample Size for Test Set: For mechanical testing, this refers to the number of device constructs tested. This information is not specified in the document (e.g., "n=5 constructs were tested").
• Data Provenance: The tests are in vitro laboratory tests, not human data.
• Ground Truth: For mechanical testing, the "ground truth" would be the engineering specifications and material science principles, and the expectation that the device should not fail under conditions prescribed by the ASTM standards.

In summary, the provided document is a regulatory submission for a physical medical device (spinal system) focusing on substantial equivalence based on prior clearances and mechanical performance testing, not on clinical performance against a diagnostic or therapeutic ground truth as your questions imply for something like an AI device.

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Lotus Series 4 Ultrasonic Surgical System & Accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. Lotus Series 4 Ultrasonic Surgical System and Accessories may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

The SRA Developments Lotus Series 4 Ultrasonic Surgical System and Accessories consists of 3 main components - the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset (Transducer and waveguide); and the disposable part of the handset (Handpiece). The Lotus Series 4 Ultrasonic Surgical System and Accessories employs torsional mode ultrasound at 35.8-36.6kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

This document describes the 510(k) summary for the Lotus Series 4 Ultrasonic Surgical System & Accessories. It details the device's improvements, its legally marketed predicate device, and the performance testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a medical device (ultrasonic surgical system), the "acceptance criteria" and "device performance" are typically framed in terms of demonstrating equivalence to a predicate device, rather than specific quantitative performance metrics against a defined threshold for AI/diagnostic algorithms. The study conducted here is a series of bench tests to demonstrate this equivalence.

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

• Generator Output Equivalence: The document states "a Transducer was driven by each generator in turn". The exact number of transducers or measurements is not specified.
• New Waveguide Design (Cutting, Hemostasis, Fatigue):
  • Cutting Speed: Tested using "our standard production cutting test". The number of waveguides or tests is not specified.
  • Hemostasis/Bleeding Control: Tested on "porcine tissue". The number of samples or tests is not specified.
  • Fatigue Resistance: Refers to "50 surgical uses" per device. "All devices" suggests more than one, but the exact number of tested waveguides is not specified.
• Handpiece Durability: "The handpieces were subjected to 600 clamping operations... All devices passed the test." The exact number of handpieces tested is not specified, but "all devices" suggests at least multiple.

Data Provenance: The studies were conducted by SRA Developments LTD, based in the United Kingdom. The tests are described as bench testing and in vitro (e.g., porcine tissue for hemostasis), indicating they are prospective tests performed in a controlled laboratory environment for the purpose of this submission. The origin of the tissue (e.g., country for porcine tissue) is not specified.

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

This type of submission for an ultrasonic surgical system does not typically involve "experts establishing ground truth" in the way an AI diagnostic algorithm for image analysis would. The ground truth for performance is established through direct physical measurements (e.g., amplitude, cutting speed, visual assessment of hemostasis, functional testing for durability and fatigue). No human experts or their qualifications are mentioned in this context.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication by experts or a consensus method. Performance is determined by objective physical measurements and functional tests.

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

Not applicable. This is a 510(k) submission for a surgical instrument, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a surgical instrument, not an algorithm, so "standalone" performance in the context of AI is not relevant. The device operates independently of human "reading" or AI interpretation.

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

The ground truth for the performance tests was based on objective physical measurements and functional parameters such as:

• Amplitude measurements for generator output.
• Measured cutting speed.
• Observed hemostasis (bleeding control) on porcine tissue.
• Continued functionality after simulated usage cycles for fatigue resistance and durability.
• Compliance with electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is an ultrasonic surgical system and not an AI/machine learning algorithm.

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

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

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The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies): spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors. The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1 - T3.

The use of polyaxial pedicle screws is limited to placement in TI-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

The Spinal Elements Lotus Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks. Screws are intended for attachment to the thoracic (T1-T3) spine only. The system achieves fixation by the mechanical joining of the rods, screws, and hooks. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

Connectors are offered in a variety of sizes and configurations and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 1472 and / or F 136. The following connectors are being added to the system:

• Offset connector .
• Round offset connector .
• Axial rod to rod connector .
• 03.5mm Axial rod to rod connector o
• 0 5.5mm Axial rod to rod connector .
• Parallel rod to rod connector .
• . 0 3.5mm Parallel rod to rod connector
• 0 5.5mm Parallel rod to rod connector ●
• Transition rods .

The provided text describes a medical device, the Spinal Elements Lotus® Posterior Cervical/Thoracic Spinal System, and its clearance through a 510(k) premarket notification. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. Instead, the document outlines the device's description, intended use, and the performance testing conducted to demonstrate substantial equivalence to a previously cleared device.

Therefore, I cannot fulfill the request as it asks for information not present in the provided text regarding acceptance criteria, device performance, AI/ML study details, and data provenance. The document is a 510(k) summary for a traditional medical device (spinal fixation system), not an AI/ML powered device.

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Esteem scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly person limited to a seated position.

The Esteem invalid scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly person limited to a seated position. The Esteem invalid scooter consist of a chassis, shroud, transaxle, seat, controller, batteries, and battery charger. It also includes a tiller handle for steering and a thumb or finger operated potentiometer throttle control level to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt 28ah sealed lead-acid (AGM or Gel type) batteries with 19 miles range. The maximum speed is up to 6mph. The rigid chassis features an advanced design that weight distribution resulting in dynamic performance that greatly improves safety and ride comfort

The provided text describes the 510(k) summary for the "Esteem scooter" by Letrix Power Hangzhou Pty Ltd. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (K103771), rather than a clinical study evaluating diagnostic performance. As such, many of the requested categories related to medical device studies proving acceptance criteria (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission for a mobility device.

However, I can extract information related to the acceptance criteria as defined by the non-clinical testing standards and the reported device performance against those standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Esteem scooter are primarily derived from various parts of the ISO 7176 series of standards, which are specific to wheelchairs, and the CE Council Directive MDD93/42/EEC essential requirements. The document states that the Esteem invalid scooter "has passed all testing requirements" and "has been tested to wheelchair standard and approvals."

Study Information (Based on the provided text):

The document details non-clinical testing to various ISO standards applicable to wheelchairs and scooters. It does not describe a clinical study in the typical sense of evaluating diagnostic performance with human subjects. Instead, it relies on engineering testing and comparison to a predicate device.

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

• Sample Size for Test Set: Not applicable for a typical clinical study of diagnostic performance. The "test set" here refers to the physical device (Esteem scooter) undergoing engineering tests. These tests are performed on the device itself and its components. The number of individual scooters tested is not specified, but typically this would involve a limited number of production units or prototypes.
• Data Provenance: The testing was conducted by Intertek Testing Services for EMC and implicitly by Letrix Power Hangzhou Pty Ltd. or a contracted lab for the other ISO standards. The document mentions the device has been in the Australian market since 2003 with "no adverse outcomes or safety related issues having been detected," implying retrospective market surveillance data from Australia.

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

• Not applicable. The "ground truth" for these engineering tests is defined by the technical specifications and performance limits set within the ISO standards themselves. The experts involved would be engineers and technicians conducting the tests and verifying compliance, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of medical data. For engineering tests, compliance is determined directly by measurements against specified thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance. This document concerns a physical mobility device, not a diagnostic AI.

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

• No. This is not an AI algorithm. The performance described is the standalone performance of the physical scooter based on engineering tests.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The ground truth is defined by the requirements and test methods outlined in the various ISO 7176 standards, as well as the manufacturer's own design specifications (e.g., maximum speed, range, slope holding).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device that requires a "training set."

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

• Not applicable. See point 8.

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The Lotus II Pulsed Er:YAG Laser System is a pulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. It outputs laser light with a wavelength of 2940 nm, a wavelength very efficiently absorbed by the skin. It is intended for coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). This includes skin resurfacing and the treatment of wrinkles

The Lotus II 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).

The Lotus II laser system is an Erbium:YAG laser with a wavelength of 2.94 um. Laser activation is by footswitch. Three basic elements of operations are as follows:

1. A Er:YAG crystal is used as a gain medium which produces a laser beam.
2. A resonator then amplifies the beam.
3. A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Er:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Lotus II Pulsed Er:YAG Laser System:

Acceptance Criteria and Device Performance Study for Lotus II Pulsed Er:YAG Laser System (K083253)

1. Table of Acceptance Criteria and Reported Device Performance

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

No specific test set data, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are provided in this 510(k) summary. The submission focuses on substantial equivalence.

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

Not applicable. No ground truth was established from an expert panel for this submission as a "performance data" study was not conducted. The determination was based on substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method was used for this submission.

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

No. There is no mention of an MRMC comparative effectiveness study in the provided document. The device's approval was based on substantial equivalence, not a clinical effectiveness study.

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

Not applicable. This device is a laser system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

No direct ground truth was established through clinical data for the Lotus II Pulsed Er:YAG Laser System. The "ground truth" for its acceptance was the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process described.

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