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MultiPulse TFL Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

• Urethral Strictures
• Bladder Neck Incisions (BNI)
• Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH)
• Transurethral incision of the prostate (TUIP)
• Laser Resection of the Prostate Laser Enucleation of the Prostate
• Laser Ablation of the Prostate
• Condyloma
• Lesions of external genitalia
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasma, Angiodysplasia, Colorectal cancer, Telangiectasia, Telangiectasia of the Osler-WeberRenu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions.

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including: Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery.

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue: Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix.

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors (oral, nasal, glossal, pharyngeal and laryngeal), Tonsillectomy, Adenoidectomy.

General surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer.

The MultiPulse TFL laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode at a wavelength of 1940 nm. The laser power up to 200W is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.

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The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).

The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.

However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document does mention:

• Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
• Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).

Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.

Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.

If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.

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The Multi M Series is used in the manufacture of dental prosthesis.

Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.

This document is a 510(k) clearance letter for a medical device called "Multi M Series", which is a dental material. The standard 510(k) clearance process by the FDA does not typically include the kind of clinical study details usually associated with AI/ML-based diagnostic devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance). This device is a material, not a diagnostic algorithm.

Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of device and submission. The "study" here refers to non-clinical performance and biocompatibility testing against international standards.

However, I can extract the relevant information where it exists:

The device in question, "Multi M Series," is a dental material (zirconia-based ceramic) used to manufacture dental prosthetics, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" and "study" described are based on non-clinical performance and biocompatibility testing against established international standards for dental materials, rather than clinical efficacy studies with human subjects or AI algorithm performance benchmarks.

Acceptance Criteria and Device Performance

The acceptance criteria are derived from ISO 6872 (for ceramic materials) and ISO 10993 (for biocompatibility).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance for "Multi M Series" either meets or exceeds the requirements set by the ISO standards and, in some cases, the performance of the predicate device (e.g., higher flexural strength, lower chemical solubility).

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

The document does not specify exact sample sizes for each mechanical or chemical test. Typically, these are defined within the referenced ISO standards (e.g., ISO 6872 specifies sample numbers for flexural strength testing).
The testing was conducted by DMAX Co., Ltd., which is based in Daegu, Korea. The data would be considered prospective, as it was generated specifically for this 510(k) submission.

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

This is not applicable as the device is a material, not a diagnostic or AI device requiring expert interpretation for ground truth. "Ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized protocols.

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

This is not applicable for the same reasons as above. There is no expert adjudication for material property testing.

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

This is not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable as the device is a dental material, not an algorithm.

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

The "ground truth" for this device relies on objective measurements defined by international standards:

• Physical/Chemical Properties: Measured values obtained through standardized laboratory tests (e.g., flexural strength, chemical solubility, CTE) as per ISO 6872 and ISO 13356. These are quantitative and inherently objective.
• Biocompatibility: Results from established in vitro and in vivo toxicology tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity) as per ISO 10993 series, which assess the material's interaction with biological systems based on predetermined endpoints.

8. The sample size for the training set

This is not applicable as this is a physical material, not a software algorithm requiring a training set.

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

This is not applicable as this is a physical material, not a software algorithm.

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The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surqical procedures in urology.

MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container. The device is available with either sterile single use blades and non-sterile reusable blades.

The provided text is related to a medical device submission (K240831) for the MultiCut Solo Morcellator. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a new device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in the provided text.

The document states that the MultiCut Solo Morcellator is a modification of an already cleared device (K213597), with the specific modification being the addition of sterile single-use blades. The submission focuses on non-clinical performance data to support the substantial equivalence.

Here's what can be extracted from the text regarding the device's assessment:

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

• No specific acceptance criteria or performance metrics related to diagnostic accuracy or clinical outcomes are provided. The submission focuses on product safety and function rather than a software algorithm's diagnostic performance.
• The document mentions that the device "successfully passed the following testing" and "is in compliance with all applicable sections of the above-mentioned performance standards." These relate to the safety and functionality of the device and its components, particularly the new sterile single-use blades. The "performance" in this context refers to meeting engineering and safety standards, not clinical diagnostic accuracy.

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

• Not applicable. The document describes non-clinical performance data (e.g., sterilization validation, biocompatibility) rather than a test set for diagnostic performance.

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

• Not applicable. There is no mention of expert-established ground truth for a diagnostic test set.

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

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. The MultiCut Solo is a mechanical morcellator, not an AI diagnostic device, and thus no MRMC study would be relevant.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. The assessments made (e.g., sterilization effectiveness, biocompatibility) are based on established scientific methods and standards (e.g., EN/ISO 10993, IEC 60601 series) rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable. The device is not based on machine learning or AI that would require a training set.

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

• Not applicable.

In summary, the provided FDA 510(k) summary focuses on the technical safety and performance of a medical device (a morcellator) and its components, specifically regarding modifications and substantial equivalence to a predicate device, rather than on the diagnostic accuracy or clinical efficacy that would involve the type of acceptance criteria and study designs typically associated with AI/software-as-a-medical-device (SaMD) clearances.

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The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.

The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.

The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.

The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).

The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.

The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.

Here's a breakdown of what can be extracted and what is missing based on your prompt:

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.

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

• NIBP: 119 subjects.
• TEMP: 105 subjects.
• SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
• Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not explicitly stated in the document.
• For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.

4. Adjudication Method for the Test Set:

• Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.

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

• Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.

7. The Type of Ground Truth Used:

• Reference device measurements.
  • NIBP: "desktop sphygmomanometer"
  • TEMP: "registered mercury thermometer"
  • SpO2/PR: Data from a previously cleared device (K170047, K063641) presumably validated against arterial blood gas or CO-oximetry as typical for oximetry.
  • No pathology or outcomes data mentioned

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The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury when conservative therapy is judged to be inadequate.

The multiFlux 1000 dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzer is provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

The provided text describes the multiFlux 1000 dialyzers' substantial equivalence to a predicate device (FX CorAL dialyzers, K220721) and does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, or most of the detailed information requested in your prompt.

Specifically:

1. Acceptance Criteria Table: No table of acceptance criteria and reported device performance is provided. The document states that the performance specifications are substantially equivalent to the predicate device and that all performance testing from the predicate device's 510(k) (K220721) is being leveraged.
2. Sample Size and Data Provenance (Test Set): Not applicable, as there is no new performance study described for the multiFlux 1000 dialyzer. The document mentions in vitro urea clearance data as an example from the Instructions for Use, but this is typical performance data, not acceptance criteria for a new study.
3. Number and Qualifications of Experts (Ground Truth - Test Set): Not applicable.
4. Adjudication Method (Test Set): Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done. The document explicitly states "No clinical studies were performed."
6. Standalone (Algorithm Only) Performance: Not applicable. The multiFlux 1000 dialyzers are physical medical devices (dialyzers), not software or AI algorithms. The document explicitly states "The multiFlux 1000 dialyzers do not contain software."
7. Type of Ground Truth Used: Not applicable, as no new performance study is described. The in vitro urea clearance data is laboratory performance data.
8. Training Set Sample Size: Not applicable. The device is not an AI/ML algorithm that requires training data.
9. Ground Truth for Training Set: Not applicable.

Summary of Relevant Information from the Provided Text:

• Acceptance Criteria and Proof of Meeting Criteria: The submission claims substantial equivalence to the predicate FX CorAL dialyzers (K220721). The changes (removal of blue colorant, extension of dialysate flange-port) are stated not to impact performance attributes. Therefore, all performance testing from the predicate device's 510(k) (K220721) is leveraged to support the multiFlux 1000 dialyzers. An example of in vitro Urea Clearance data is provided in Table 3 (page 5), but this is not presented as an acceptance criterion from a new study specific to the multiFlux 1000.
• Human Factors Validation Testing: "The multiFlux 1000 dialyzers were found to be safe and effective for their intended users, uses, and use environments." The details of this testing (acceptance criteria, sample size, outcome metrics) are not provided.
• Biocompatibility Testing: The multiFlux 1000 dialyzers are chemically equivalent to the predicate FX CorAL dialyzers per ANSI/AAMI/ISO 10993-18:2020, Annex C.4.d. The removal of blue colorant did not require additional biocompatibility testing. This implies that the previous biocompatibility testing for the predicate device is considered sufficient.

In essence, the document focuses on demonstrating substantial equivalence based on prior testing of a predicate device and states that no new clinical or animal studies, or software verification/validation, were performed for the multiFlux 1000 dialyzers.

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

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

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

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

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

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

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

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

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

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For over-the-counter use.

Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For prescription use only.

The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup. Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document is a 510(k) Summary for the Shanghai Accurature Diagnostics Co., Ltd. Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card. It describes the device's indications for use, its substantial equivalence to a predicate device, and performance data from various studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly state "acceptance criteria" for precision or agreement. However, it indicates a "qualified" result for percentage agreement among positives and negatives in the comparison study (Section 10.1). For precision (Section 10.7), it states a cutoff coincidence rate of 79% (which is >55%) and a ±25% cutoff coincidence rate of 88% (which is >84%), both deemed "qualified." For the lay user study, the percentages of agreement for specific concentrations are presented. Given that these devices are screening tools, the implicit acceptance criteria would be high agreement rates (ideally 100% or very close) for negative and strongly positive samples, and reasonable agreement around the cutoff concentrations.

Here's a summary of the reported performance from the comparison study, which appears to be the primary study for establishing initial performance characteristics:

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

• Comparison Study (Section 10.1): The sample size is not explicitly stated as a single number. The tables show "agreement among positives" and "agreement among negatives" for each drug with percentages. While not directly stated, the implication is that a sufficient number of samples were tested to generate these percentages. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
• Precision Study (Section 10.7): For each drug, the study tested "drug free," "-75%Cut off," "-50%Cut off," "+100% cutoff," "+75%Cut off," and "+50%Cut off" samples. The number of samples per concentration is not explicitly given, but the results for "-75%Cut off," "-50%Cut off," "drug free" samples were all negative, and "+100% cutoff," "+75%Cut off," "+50%Cut off" samples were all positive. The specific number of samples at the cutoff and ±25% cutoff concentrations that led to the "79%(>55%)" and "88%(>84%)" coincidence rates, respectively, is not provided.
• Lay User Study (Section 10.8):
  • Test Cup: 603 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
  • Test Dip Card: 300 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
  • Data Provenance: Not specified (e.g., country of origin or retrospective/prospective). However, the study involved "three intended user sites" and "diverse educational and professional backgrounds."

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)

• Lay User Study (Section 10.8): The ground truth for the lay user study was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly reliable analytical chemical method. This is not dependent on human expert interpretation of the test results themselves, but rather on instrument analysis. The samples were "spiking drug free-pooled urine specimens" with known concentrations, and these concentrations were "confirmed by LC/MS." Therefore, the ground truth is analytical, not expert consensus on the device's outcome.
• For other studies like the Comparison Study and Precision, the method for establishing ground truth isn't explicitly detailed, but generally, for drug screening devices, analytical methods (like GC/MS or LC/MS) are considered the gold standard for ground truth.

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

• No information on adjudication methods such as 2+1 or 3+1 is provided. The studies appear to rely on objective measures (percentages of agreement with an assumed or analytically confirmed truth). For the lay user study, the ground truth was analytical (LC/MS), eliminating the need for reader adjudication.

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

• This question is not applicable to the provided document. The device is a lateral flow immunochromatographic assay (a rapid drug test), not an AI-powered diagnostic system or an imaging modality that would involve human readers interpreting images. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance is irrelevant to this device.

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

• This question is not applicable. The device is a physical diagnostic kit (test cup/dip card) that provides a qualitative result (presence or absence of a line). It is not an algorithm, and its performance is inherently "standalone" in that it produces a result without further computational analysis. The "human-in-the-loop" aspect for this device involves a person performing the test and visually interpreting the lines, particularly in the over-the-counter (OTC) use case. The lay user study evaluates this "human-in-the-loop" performance.

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

• The primary type of ground truth used, particularly for the lay user study, was analytical chemical confirmation, specifically LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision study, samples were prepared at specific concentrations relative to the cutoff, implying a known, analytically verified concentration as the ground truth. This is considered a highly objective and accurate method for determining the presence and concentration of substances.

8. The sample size for the training set

• The document describes performance studies, cross-reactivity, interference, and a lay user study. It does not mention a "training set" in the context of machine learning or algorithm development. The device is a lateral flow immunoassay, which does not involve a training set as would be found in AI/ML applications. The studies described are for validation of the physical test device.

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

• As there is no "training set" for this type of device, this question is not applicable. The underlying principles of the immunoassay are based on chemical reactions, not on data learned from a training set.

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Laser Device:

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enucleation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate Dehydrate stones Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma Angiodysplasia Colorectal cancer

Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Arthroscopy

Arthroscopy / Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

Laser Device:

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enucleation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate Dehydrate stones Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma Angiodysplasia Colorectal cancer

Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Arthroscopy

Arthroscopy / Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

This document is an FDA 510(k) clearance letter for the MultiPulse HoPLUS Laser system and MultiCut Solo Morcellator. It outlines the regulatory approval and intended uses of the device.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond its substantial equivalence to predicate devices and adherence to general controls.

The document primarily focuses on:

• Confirming the 510(k) clearance (K231876) for the MultiPulse HoPLUS Laser and MultiCut Solo Morcellator.
• Stating its classification as a Class II device.
• Listing its broad Indications for Use across various medical specialties (Urology, Gastroenterology, Arthroscopy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery).
• Mentioning regulatory requirements and guidance documents.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided FDA clearance letter.

The FDA 510(k) pathway for medical devices largely relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics or comparison against specific, pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission might. While the manufacturer would have submitted data to the FDA to support the substantial equivalence claim, the details of those studies and specific acceptance criteria are not typically included in the public-facing clearance letter.

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