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Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

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

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

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

   • Not applicable. This device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

8. 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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This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

This product shall not be used for other purposes.

The Single-Use Video Flexible Cysto-Nephroscope mainly consist of insertion portion, handle and connector section which include a detachable video cable which connect the endoscope to the Endoscopic Video Image Processor.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (Single-Use Video Flexible Cysto-Nephroscope), not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a predicate device based on non-clinical performance testing of the physical properties and functionality of the endoscope itself. There is no mention of any AI component or software that processes images or provides diagnostic assistance.

Here's a breakdown of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The proposed device has met the testing acceptance criteria in accordance with internal requirements and applicable standards to support substantial equivalence of the proposed device." However, it does not provide a specific table listing detailed acceptance criteria and the corresponding reported performance values for each physical test. It only lists the types of tests performed.

• Sterilization Validation:
  • Acceptance Criteria: Determined by ISO 11135:2014 half-cycle method to establish routine control and monitoring parameters.
  • Reported Performance: Method validated. (Specific parameters not provided).
• Shelf Life and Simulated Transportation Distribution followed by Sterile Packaging Integrity Test:
  • Acceptance Criteria: Validated according to ASTM F1980-21, ISO11607-1:2019, ISO11607-2:2019, ASTM F1929-23, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23.
  • Reported Performance: Validated. (Specific results not provided).
• Performance Testing (using methods and acceptance criteria from K241500):
  • Surface and Edges:
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.
  • Deflection system and Fatigue test of Rocker and Bending Section: (Note: Downward deflection angle changed from 135° to 225° for all models).
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.

Information Not Applicable to this Device/Document (for AI/ML products):

The following points are typically relevant for AI/ML device submissions but are not found in this document because it pertains to a physical, non-AI medical instrument.

• Sample sized used for the test set and the data provenance: Not applicable. Evaluation was based on physical device testing, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The study described is a non-clinical performance testing study for a physical medical device (endoscope), designed to demonstrate substantial equivalence to a previously cleared predicate device. It involves component and system-level testing of physical characteristics, sterilization, packaging integrity, and functionality based on established industry standards and previous submission's methodologies. There is no AI or software performance evaluation in this clearance.

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U2 Total Knee System - PF+ is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.

USTAR II Total Knee System

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).

The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.

However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).

Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.

The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.

Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:

Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):

Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:

• Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
• Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.

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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL) with safety and efficacy. It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain and nearly heatless.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.

The provided FDA 510(k) clearance letter and summary for the "Ice Cooling IPL Hair Removal Device" describe a medical device submission and its review. However, it does not contain the specific information required to describe acceptance criteria and associated study results for an AI/ML-based medical device.

The document primarily focuses on:

• Regulatory classification and product codes: Identifying the device as Class II, Product Code OHT, under 21 CFR 878.4810.
• Intended use: Hair removal and permanent reduction in hair regrowth.
• Comparison to predicate devices: Demonstrating substantial equivalence in terms of intended use, design, specifications, and performance (e.g., wavelength range, energy density, spot size).
• Performance data (Non-Clinical): Referring to biocompatibility testing, electrical safety (EMC), light safety, software verification and validation (not AI-specific performance), and usability testing, all against established industry standards (IEC, ISO).

Crucially, there is no mention of:

• AI/ML components: The device is described as an Intense Pulsed Light (IPL) device, and its operation does not inherently involve AI/ML. "Software Verification and Validation" is a standard requirement for electronic medical devices and does not imply AI.
• Clinical study data for performance metrics: The performance data section refers only to non-clinical tests (biocompatibility, electrical safety, light safety, software V&V, usability). It does not provide details on clinical efficacy (hair reduction) studies with specific performance metrics, sample sizes, or ground truth establishment relevant to the device's hair removal claim. The "permanent reduction in hair regrowth" indication implies clinical testing, but the details are not present in this summary.
• Expert consensus, MRMC studies, or specific AI performance metrics like sensitivity, specificity, AUC: These are typical elements of a study proving an AI device meets acceptance criteria.

Therefore, it is not possible to fill in the requested table and answer the questions based solely on the provided text, as the device described is not an AI/ML medical device, and the document focuses on non-clinical substantial equivalence rather than detailed clinical performance of the hair removal efficacy.

Hypothetical Example (if this were an AI/ML device and the text provided the necessary details):

If, for instance, the device had an AI component to detect skin type or predict hair regrowth, and the document detailed a study on this AI component, the information could be extracted like this (this is purely illustrative and not based on the provided text):

Hypothetical Acceptance Criteria and Study for an AI-Powered Hair Removal Device

Let's imagine this device also had an AI feature, for example, an integrated AI system that analyzes skin pigmentation to recommend optimal IPL settings to minimize adverse events and maximize efficacy.

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

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

• AI Skin Type Classification Test Set: 1500 images/cases (1000 for training, 500 for validation/testing).
• Adverse Event/Efficacy Test Set (Clinical Trial): 300 participants.
• Data Provenance:
  • Skin images for AI classification: Retrospective dataset collected from dermatology clinics in North America (USA, Canada) and Europe (UK, Germany).
  • Clinical trial for adverse events/efficacy: Prospective, multi-center, randomized controlled trial conducted in the USA (5 sites) and China (3 sites).

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

• Skin Type Ground Truth: 3 board-certified dermatologists, each with a minimum of 10 years of experience in aesthetic dermatology and laser/IPL treatments. All were trained to consistently apply Fitzpatrick Skin Type scale.
• Adverse Event/Efficacy Ground Truth: Clinical investigators (dermatologists) at each trial site, with at least 5 years of experience in IPL/laser treatments, reviewed and graded adverse events and hair reduction independently at follow-up visits.

4. Adjudication method for the test set

• Skin Type Ground Truth: For the AI classification test set, initial skin type labels were provided by one expert. For any ambiguous cases (e.g., initial disagrement or boundary cases), a 3-expert consensus (2+1 majority rule) was used. If a consensus was not reached (e.g., 1-1-1 split), the case was excluded from the ground truth set.
• Adverse Event/Efficacy Ground Truth: For clinical trial outcome adjudication, two independent, unblinded dermatologists graded outcomes (hair reduction percentage, adverse events) at each follow-up visit. In case of discrepancy, a third blinded dermatologist acted as an adjudicator to reach a consensus.

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

• Yes, an MRMC study was performed to assess the impact of AI-recommended settings vs. manual-expert settings on clinical outcomes.
• Study Design: 10 IPL therapists/dermatologists (readers) were recruited. They each reviewed 50 simulated patient profiles (cases) and recommended IPL settings.
  • Group A (without AI): Readers used standard clinical guidelines and their experience.
  • Group B (with AI assistance): Readers were provided with the AI system's recommended settings and could choose to accept, modify, or reject them.
• Effect Size: The AI-assisted group (Group B) demonstrated a statistically significant improvement in the rate of optimal setting selection (leading to good outcomes without adverse events) by 15% (Cohen's d = 0.65) compared to the unassisted group (Group A). Specifically, the rate of selecting optimal, safe, and effective settings increased from 70% (unassisted) to 85% (AI-assisted).

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

• Yes, a standalone performance evaluation of the AI skin type classification module was conducted prior to its integration into the device and the MRMC study. This included the accuracy, sensitivity, and specificity metrics mentioned in section 1.

7. The type of ground truth used

• Expert Consensus: For skin type classification (AI module training and testing).
• Clinical Outcomes Data: For validating the safety and efficacy of AI-recommended settings (adverse event rates, hair reduction percentage from prospective clinical trial data).

8. The sample size for the training set

• AI Skin Type Classification: 15,000 unique skin images with associated Fitzpatrick Skin Type labels.

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

• The ground truth for the training set was established by three experienced board-certified dermatologists, similar to the test set experts. Each image was independently reviewed and labeled by all three. If discrepancies occurred, a consensus process involving discussion and re-evaluation was used to arrive at a final label. This iterative process ensured high-quality, reliable ground truth data for training the AI model.

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The Unimed disposable blood pressure cuff (Models U1682S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (4–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

The Unimed Disposable Neonatal NIBP Cuffs (Models U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N) are single-patient-use accessories for non-invasive blood pressure (NIBP) measurement. Each cuff is designed for neonatal limb circumferences ranging from 4 cm to 15 cm (Neonate 2 through Neonate 5) as follows.

• U1682S-C51N: 4 cm - 8 cm.
• U1683S-C51N: 6 cm - 11 cm.
• U1684S-C51N: 7 cm - 13 cm.
• U1685S-C51N: 8 cm - 15 cm.
  The cuffs are intended to be used with compatible blood pressure monitors employing oscillometry. They are non-sterile, and are disposed of after single-patient use to reduce cross-contamination risks.

This 510(k) clearance letter is for a Disposable Neonatal NIBP Cuff. It does not describe an AI/ML powered medical device, nor does it detail a study involving AI/ML.

Therefore, many of the requested criteria related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing and material biocompatibility.

Here's the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to meet acceptance criteria for a physical medical device:

Acceptance Criteria and Device Performance for Disposable Neonatal NIBP Cuff

The acceptance criteria for this device are primarily based on established international standards for non-invasive blood pressure cuffs and biocompatibility. The performance is demonstrated through non-clinical testing, confirming adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The non-clinical testing likely involved a representative sample of each cuff model (U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N).
• Data Provenance: The document states "Non-clinical tests were conducted..." but does not specify the country of origin where the testing was performed. Given the manufacturer's location (Shenzhen, China), it's plausible the testing was conducted there or at a certified lab supporting the manufacturer. The testing is described as non-clinical, implying it was laboratory-based product verification and validation, not retrospective or prospective human clinical data collection.

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

This is not applicable. This document describes the clearance of a physical medical device (NIBP cuff) via substantial equivalence, not an AI/ML algorithm. Therefore, there is no mention of "ground truth" derived from expert consensus on medical images or data. The "ground truth" for this device would be the defined specifications and performance requirements established by the relevant ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings, especially for AI/ML performance evaluation where multiple human readers might disagree on findings. For non-clinical device testing like this, adherence to predefined test protocols and specifications is the primary method of evaluation.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a non-AI medical device like a blood pressure cuff.

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

No, a standalone performance evaluation of an algorithm was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized consensus standards (ISO 81060-1, ISO 80601-2-30, and ISO 10993 series for biocompatibility). The device's performance metrics are evaluated against the specific requirements and test methods outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for ciprofloxacin in the dilution range of 0.002-64 ug/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL demonstrated acceptable performance with the following organisms:

Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter (K250990) for "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL" does not include detailed information about the acceptance criteria or the specific study that proves the device meets those criteria. The letter primarily serves as a notification of substantial equivalence and outlines regulatory requirements.

However, based on the nature of the device (Antimicrobial Susceptibility Test) and the context of FDA clearance for such products, we can infer the typical types of acceptance criteria and studies that would have been conducted. Please note that the specific numerical values for acceptance criteria and study details are not present in the provided document and would normally be found in the manufacturer's 510(k) submission summary.

Here's a breakdown of the requested information, with inferred details for sections not explicitly stated:

Acceptance Criteria and Device Performance

Note: The specific acceptance criteria (e.g., % Essential Agreement, % Category Agreement) and the reported device performance for the Sensititre system with Ciprofloxacin are not provided in the FDA clearance letter. For an AST device, these usually revolve around agreement with a reference method.

Inferred Acceptance Criteria and Hypothetical/Typical Reported Performance for AST Devices:

Explanation of Terms (for AST devices):

• Essential Agreement (EA): The Minimum Inhibitory Concentration (MIC) result of the test device is within ±1 doubling dilution of the reference method's MIC result.
• Category Agreement (CA): The interpretive category (Susceptible, Intermediate, Resistant) assigned by the test device matches the interpretive category assigned by the reference method.
• Minor Errors (mE): One method (test or reference) interprets as Intermediate, and the other interprets as Susceptible or Resistant.
• Major Errors (ME): The test device interprets as Susceptible, but the reference method interprets as Resistant. This is a critical error as it could lead to ineffective treatment.
• Very Major Errors (VME): The test device interprets as Resistant, but the reference method interprets as Susceptible. This is also a critical error as it could lead to unnecessary use of broader-spectrum antibiotics.

Study Details (Inferred/Typical for AST Devices)

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

   • Sample Size (Test Set): Not specified in the clearance letter. For AST devices, test sets typically involve hundreds to thousands of unique isolates for each organism-antibiotic combination to ensure statistical significance across various resistance mechanisms and phenotypes. This would include both common and challenging strains.
   • Data Provenance: Not specified. For FDA submissions, the data provenance is usually a mix of prospective and retrospective clinical isolates, often collected from diverse geographical regions (e.g., multiple centers across the United States) to represent a broad range of clinically relevant strains. The clearance letter mentions testing for "Enterobacterales" and "Pseudomonas aeruginosa," indicating a focus on these specific bacterial groups.

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

   • Number of Experts: Not specified. For AST devices, ground truth is typically established by reference laboratory personnel highly experienced in microbiology, particularly in performing and interpreting reference AST methods (e.g., broth microdilution or agar dilution as per CLSI guidelines). These are not usually "experts" in the sense of clinicians reading images, but rather highly skilled microbiologists.
   • Qualifications of Experts: Clinical microbiologists, medical technologists, or laboratory scientists with extensive experience (e.g., 5-10+ years) in a clinical microbiology reference laboratory, proficient in CLSI (Clinical and Laboratory Standards Institute) methodologies for antimicrobial susceptibility testing.

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

   • Adjudication Method: Not applicable in the traditional sense for AST devices when comparing to a recognized reference method. The "ground truth" (reference method results) is considered definitive. If initial discrepancies occur between the test device and the reference method, these are typically re-tested by the reference method for confirmation rather than adjudicated by human readers. The reference method (e.g., CLSI broth microdilution) is itself the gold standard.

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

   • MRMC Study: Not applicable. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. The Sensititre system is an in vitro diagnostic device for antimicrobial susceptibility testing, which directly measures bacterial growth inhibition at various antibiotic concentrations (MICs). It does not involve human "readers" interpreting output in the same way as an imaging device, nor does it typically involve AI assistance in its core mechanism for determining MICs.

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

   • Standalone Performance: Yes, the core evaluation of an AST device like Sensititre is a standalone performance study. The device, when operated according to its instructions for use, generates MIC results and interpretive categories. These results are then compared directly to the reference method. There isn't typically a "human-in-the-loop" for the determination of the MIC or category by the device itself, although human laboratory personnel perform the setup and interpretation of the result in the clinical workflow. The performance data presented in the 510(k) submission would reflect this intrinsic performance of the device.

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

   • Type of Ground Truth: For AST devices, the ground truth is established by a recognized reference method, typically the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method or agar dilution method. This is considered the "gold standard" for determining MICs and susceptibility categories. It is a highly standardized and reproducible laboratory procedure.

7. The sample size for the training set:

   • Sample Size (Training Set): Not applicable in the same way as for AI/machine learning algorithms. The Sensititre system is a phenotypic AST system, not an AI-based diagnostic algorithm that requires a "training set" of data. Its "training" is inherent in its design and manufacturing, based on established microbiological principles for detecting bacterial growth and inhibition. Any "development" data would be internal to the manufacturer for optimizing plate format, reagent concentrations, and reading algorithms, but not a "training set" in the context of deep learning.

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

   • Ground Truth for Training Set: Not applicable for this type of device. As explained above, the device does not use a "training set" with established ground truth in the AI sense. Its underlying principles are based on microbiological standards and reference methods.

Summary of Information from the FDA Letter:

• Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL
• Intended Use: In vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for Ciprofloxacin in the stated dilution range against Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens) and Pseudomonas aeruginosa.
• Performance: "demonstrated acceptable performance" (no specific metrics or values provided in the clearance letter).

To obtain the detailed acceptance criteria and study specifics, one would need to review the manufacturer's 510(k) summary, which is typically a public document available through the FDA's 510(k) database.

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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for ceftobiprole in the dilution range of 0.008-16 µg/mL for testing fastidious isolates on the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System. Testing is indicated for Streptococcus pneumoniae and Streptococcus pyogenes, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms:

• Streptococcus pneumoniae
• Streptococcus pyogenes

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the device is substantially equivalent to a previously cleared device, rather than requiring the submission of a de novo study including specific acceptance criteria and detailed study results. The letter does not describe the specific study design, sample sizes, expert qualifications, or ground truth methods used to establish the performance of the device itself against predefined acceptance criteria. Instead, it focuses on the administrative aspects of the 510(k) clearance process, regulatory compliance, and the device's intended use.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample sizes used for the test set and data provenance: Not detailed in the letter.
3. Number of experts used to establish ground truth and their qualifications: Not detailed in the letter.
4. Adjudication method: Not detailed in the letter.
5. MRMC comparative effectiveness study details or effect size: This type of study is typically for AI/imaging devices, not for an antimicrobial susceptibility test system as described. Even if it were relevant, the information is not present.
6. Standalone (algorithm only) performance: Not applicable to this type of device and not mentioned.
7. Type of ground truth used: Not detailed in the letter.
8. Training set sample size: Not detailed in the letter.
9. How ground truth for the training set was established: Not detailed in the letter.

The primary purpose of this FDA letter is to inform the manufacturer of the clearance and the associated regulatory requirements, not to disseminate the specifics of the underlying performance studies that led to the substantial equivalence determination.

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The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones.

The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer.

Control platform is integrated control of electric cabinet, main engine and treatment bed.

Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control.

Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside.

Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA.

Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling.

Principle of operation:

The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.

This document is a 510(k) clearance letter for an Extracorporeal Shock Wave Lithotripter (U200). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the clinical study's primary effectiveness endpoint. Instead, the clinical study aims to demonstrate that the device has a "safety and effectiveness profile that is similar to the predicate device." The reported device performance is presented as successful outcomes in various subgroups. The key performance metrics are "effective rate" for stone fragmentation.

• FAS (Full Analysis Set): 79.2%
• PPS (Per-Protocol Set): 86.4% |
  | Localization Accuracy: Auxiliary positioning target error, number of auxiliary positioning operations, and total time of auxiliary positioning operations should demonstrate relative speed, accuracy, and convenience. | Localization Performance:
• Auxiliary positioning target error: within 3mm
• Number of auxiliary positioning operations: within 3 times
• Total time of auxiliary positioning operations: within 15min
  (Stated as "relatively fast, accurate, and convenient, and the system ergonomics performance is good.") |
  | Safety: Device should be safe with no device malfunctions reported in the clinical investigations. | Safety: "The incidence of device malfunction does not happen in these clinical investigations." "patients treated by the Extracorporeal Shock Wave Lithotripter (model: U200) are safe." |
  | Subgroup Effectiveness (Inferred, as results are presented): Demonstrate effectiveness across different stone sizes, locations, and densities. | Stone Size:
• Stones 5-10mm (FAS): 92.9% effective rate
• Stones 10-15mm (FAS): 60.0% effective rate
• Stones 5-10mm (PPS): 100% effective rate
• Stones 10-15mm (PPS): 66.7% effective rate |
  | | Stone Location:
• Kidney stones (FAS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (FAS): 78.6% effective rate (Upper ureteral: 70.0%, Middle ureteral: 100%, Lower ureteral: 100%)
• Kidney stones (PPS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (PPS): 91.7% effective rate (Upper ureteral: 87.5%, Middle ureteral: 100%, Lower ureteral: 100%) |
  | | Stone Density:
• Density 1000HU (FAS): 81.8% effective rate
• Density 1000HU (PPS): 81.8% effective rate |

Study Details from the Provided Text:

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

   • Clinical Test Set Sample Size: 25 subjects enrolled, 22 subjects completed the study. (4 subjects failed screening, 3 dropped out). The study used both a Full Analysis Set (FAS) and a Per-Protocol Set (PPS) for effectiveness calculation, implying some missing data handled by intent-to-treat (FAS) and per-protocol (PPS).
   • Data Provenance: The clinical investigation was a "multicenter, open-label clinical design." The specific countries of origin for the clinical data are not mentioned, but the manufacturer and correspondent are based in China. The retrospective or prospective nature is not explicitly stated, but "clinical investigations" with "subjects screened," "enrolled," and "followed for a period of follow-up" strongly suggest a prospective study design.

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

   • The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for stone fragmentation. The primary effectiveness endpoint, "effective rate," is defined based on the outcome of the ESWL treatment, likely assessed clinically (e.g., successful fragmentation and clearance/passage of stones). This assessment would typically be done by treating physicians (urologists) or through imaging (e.g., ultrasound, X-ray) reviewed by radiologists, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for assessing the "effective rate" or other clinical outcomes. It suggests that the clinical outcomes were observed and reported as part of the study.

4. 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:

   • No. This device is an Extracorporeal Shock Wave Lithotripter, which is a physical medical device for breaking up stones, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Not applicable in the AI sense. The device's primary function is a physical therapy. However, the document does mention "PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling." It also states "Software Verification and Validation was performed, and it was demonstrated that the software performs as intended." This implies a standalone software performance assessment, but not a standalone diagnostic algorithm performance assessment. The device's "localization/stone targeting system" appears to be an integral part of its operation, not a separate diagnostic algorithm.

6. The Type of Ground Truth Used:

   • For the clinical effectiveness endpoint ("effective rate"), the ground truth is based on clinical outcomes (successful stone fragmentation and presumed clearance) observed in patients after receiving ESWL treatment. This would typically be assessed by follow-up imaging and clinical evaluation.
   • For Localization Accuracy, the ground truth was likely established by physical measurements comparing the "target location" to the "shock wave focus."

7. The Sample Size for the Training Set:

   • The document does not mention a separate training set or its sample size for the clinical study. This is a medical device clearance, not an AI model development project where explicit training sets are typically discussed. If any software component used machine learning, details of its training would be relevant, but those are not provided. The clinical study described appears to be a validation/test set for the entire system's clinical performance.

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

   • Since no explicit training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text.

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