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Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.

The device is designed for children greater than five years of age, adolescent and adult subjects.

Safey Peak Flow Meter is an over-the-counter medical device to help respiratory patients keep track of their lung health. This device measures Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). Safey Peak Flow Meter is a pocket device intended for home use and operates on two AAA type standard alkaline batteries.

Safey Peak Flow Meter works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to PEF and FEV1. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.

The provided text describes the Safey Peak Flow Meter and its associated mobile application, which appears to be a Class II medical device intended for home use to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1). The document K200832 details the device's substantial equivalence to a predicate device, Smart One (K181666).

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Safey Peak Flow Meter are primarily derived from international standards and guidance documents, particularly those related to accuracy for spirometry devices.

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

The provided summary does not explicitly state the sample size used for the primary accuracy testing of the device. It mentions that the device was "tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry -2005'".

• Sample Size: Not specified in the provided document for the "Flow/Volume Simulator" test.
• Data Provenance: The document implies that the testing was conducted in India by the manufacturer Safey Medical Devices Pvt Ltd as the company is based there. The nature of the testing with a simulator indicates it is a prospective test (performed specifically for this submission).

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

For the accuracy testing against ATS/ERS standards using a Flow/Volume Simulator, the "ground truth" is established by the calibrated output of the simulator itself, which is designed to produce precise, known flow and volume profiles. Therefore, no human experts were used to establish ground truth for this specific performance test. The standard itself (ATS Standardization of Spirometry -2005) provides the expert consensus on what constitutes accurate spirometry measurements.

4. Adjudication Method for the Test Set

As the accuracy testing was conducted against a Flow/Volume Simulator, which provides a definitive and calibrated reference, no adjudication method involving human reviewers was necessary or applicable. The device's measurements were compared directly to the simulator's known outputs.

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

No MRMC comparative effectiveness study was done or reported in the provided document. The Safey Peak Flow Meter is a direct measurement device, not an AI-assisted diagnostic tool that interprets complex medical images or signals requiring human expert review. Its performance is evaluated based on its accuracy in measuring PEF and FEV1 against a calibrated standard.

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

Yes, the primary performance testing (accuracy of PEF and FEV1 measurements) was a standalone algorithm-only performance assessment. The device, through its embedded algorithm, calculated PEF and FEV1, and these measurements were compared against the outputs of a Flow/Volume Simulator. This evaluation did not involve a human in the loop for the actual measurement determination. The device's mobile app displays these results to the user, but the core measurement is standalone.

7. The Type of Ground Truth Used

The ground truth used for the accuracy of PEF and FEV1 measurements was calibrated output from a Flow/Volume Simulator, defined by the American Thoracic Society (ATS) Document "Standardization of Spirometry -2005" standards.

8. The Sample Size for the Training Set

The provided document does not detail any machine learning or AI model training for the core PEF and FEV1 measurement function, nor does it specify a training set size. The device operates on an "infrared interrupt concept" to measure the rotation of a vane within a turbine, which is a physical principle rather than a data-driven AI model in the traditional sense. While there is software in the device and app, it appears to be deterministic for calculations and data management, and the document focuses on software verification and validation rather than training data.

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

Since no specific training set for a machine learning model is mentioned for the direct measurement function, the concept of "ground truth for the training set" as it relates to AI models is not applicable in this document. The ground truth for the device's operational accuracy relies on the physical principles and calibration against the ATS standards via the simulator.

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Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

Safey Pocket Spirometer is a prescription use medical device to help respiratory patients keep track of their lung health. This device is a portable spirometer intended for above 5 years of age. Safey Pocket Spirometer is a pocket device intended for home use and operates on two AAA type standard alkaline batteries. Safey Pocket Spirometer works on infrared interrupt concept. The turbine consists of a vane which rotates clockwise or anti-clockwise depending on the direction of flow into the turbine. The device consists of Infrared pairs which detects the direction and speed of rotation of the vane, which is further calculated to interpretable spirometry values. The device connects with a Medical Mobile Application (Safey App) using BLE (Bluetooth Low Energy) to display the test results to the User.

The provided document, a 510(k) Summary for the Safey Pocket Spirometer, outlines the device's technical characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device (Spirobank G, K072979). While it details various non-clinical tests and adherence to standards, it does not provide acceptance criteria tables or the specific results of the ATS/ERS flow/volume simulator test in a format that directly addresses the prompt's request for "acceptance criteria and reported device performance" with specific numerical values for metrics like accuracy, precision, sensitivity, or specificity.

The document states: "The Safey Pocket Spirometer device was tested on a Flow/Volume Simulator according to American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005'. The results obtained show that Safey Pocket Spirometer display results within ATS limits." This implies that the device met the ATS standards for spirometry accuracy, but the numerical acceptance criteria and the actual performance results are not explicitly tabulated.

Therefore, the following response will infer some acceptance criteria based on the comparison table and general industry standards (ATS/ERS) and report the device's performance as "meets ATS limits" where specific numbers are not provided. Much of the requested information (e.g., sample size for test/training sets, number and qualifications of experts, adjudication methods) is absent from this 510(k) summary, as these details are typically required for studies involving qualitative or diagnostic AI/ML models with human performance components, rather than a quantitative measurement device like a spirometer.

Acceptance Criteria and Device Performance for Safey Pocket Spirometer

The Safey Pocket Spirometer is a diagnostic spirometer. The primary performance evaluation for such devices revolves around the accuracy of flow and volume measurements against established standards, such as those from the American Thoracic Society (ATS) and European Respiratory Society (ERS).

1. Table of Acceptance Criteria and Reported Device Performance

Given the information provided in the 510(k) summary, the acceptance criteria are implicitly based on the ATS/ERS standards, and the reported performance is that the device meets these standards. The comparison table with the predicate device also indicates shared performance characteristics.

Note: The document only states that "The results obtained show that Safey Pocket Spirometer display results within ATS limits." It does not provide the exact numerical results for accuracy beyond stating that it meets the accepted limits.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a separate "test set" sample size in terms of human subjects or distinct spirometry measurements. The performance testing was conducted on a "Flow/Volume Simulator." The number of samples/measurements performed on this simulator is not specified.
• Data Provenance: The testing was non-clinical, done on a simulator, and focused on device accuracy rather than patient data. The device manufacturer, Safey Medical Devices Pvt Ltd, is based in Pune, Maharashtra, India.

3. Number and Qualifications of Experts for Ground Truth

This type of device (a diagnostic spirometer) does not typically require human experts to establish "ground truth" in the same way an AI/ML diagnostic imaging device would. The ground truth for spirometry measurements is established by physical standards and calibrated simulators, often traceable to national or international metrology standards. Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable. As the testing was conducted on a flow/volume simulator, no human adjudication was involved in generating the "ground truth" measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a standalone measurement device, not an AI-assisted diagnostic tool designed to improve human reader performance. Its performance is validated against physical standards, not human interpretations.

6. Standalone Performance (Algorithm Only)

The provided data describes the standalone performance of the device (Safey Pocket Spirometer) and its integrated software. The device's ability to accurately measure and report spirometry values (volume, flow, etc.) is the core of its standalone performance. The testing against ATS/ERS standards on a flow/volume simulator represents this standalone (algorithm/device only) validation.

7. Type of Ground Truth Used

The ground truth used was based on physical standards and calibrated spirometry flow/volume simulators. These simulators are designed to generate precise and known flow and volume patterns, serving as the "true" values against which the device's measurements are compared. The reference for these ground truth values is the American Thoracic Society (ATS) Document "Standardization of Spirometry - 2005."

8. Sample Size for the Training Set

Not applicable/Not specified. This device operates on an "infrared interrupt" concept to measure flow and volume, which relies on physical principles and calibration rather than machine learning models that require large training data sets. Therefore, there's no "training set" in the context of an AI/ML algorithm.

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

Not applicable, as there is no training set for a machine learning algorithm. The device's method of operation is based on established physics and engineering principles, not learned patterns from data.

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The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis). transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrodes Series consist of an active tip, PTFE color code identification, and an insulator between the electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrode tips vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops or buttons. The system includes single-use electrodes that can be connected to a working element (only WA22366A – K100275), or the use of the single-use electrodes together other compatible electrosurgical cables as applicable. Compatible Generators to any of the electrodes include generators with output specifications that meet the following criteria: 100-120/220-240V, ~50-60Hz/1000VA, 310-380 kHz, 320W/200 Ω, Int 10s/30s.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "ACE Electrosurgical Resection and Vaporization Electrodes Series." This document primarily discusses the substantial equivalence of the new device to a predicate device, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Here's an analysis of the information, addressing your points where possible, and noting when the information is not present in this type of FDA submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific device performance metrics in the way you might expect from a clinical study report. Instead, it relies on demonstrating equivalence to an existing predicate device and conformance to recognized consensus standards.

Acceptance Criteria (Implied / Stated):

• Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device (K120418, Olympus Winter & Ibe GmbH Electrosurgical Resection and Vaporization Electrodes Series) in terms of:
  • Indications for Use
  • Principles of Operation
  • Technological Characteristics
  • Materials
  • Performance (demonstrated through bench testing and conformance to standards)
• Safety and Effectiveness: Does not raise new issues of safety or effectiveness.
• Electrical Safety: Conforms to IEC 60601-1.
• Thermal Safety: Conforms to IEC 60601-2-2.
• Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity.
• Sterilization: Ethylene Oxide (EO) with a Sterility Assurance Level (SAL) of 10-6.
• Risk Analysis: Performed in accordance with ISO 14971:2007.

Reported Device Performance:

The document states that "Design verification was performed to ensure the device functions according to its intended use, and the results met their acceptance criteria." However, it does not provide the specific numerical results of this design verification. It only confirms that the testing was performed and met the criteria.

The "Comparison of Characteristics" table (Table 5A) highlights the similarities between the applicant's device and the predicate device across various attributes. This comparison serves as the performance data in terms of demonstrating equivalence.

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

This document describes a 510(k) submission, which relies heavily on non-clinical (bench) testing and comparison to a predicate device, rather than a clinical trial with a "test set" of patients.

• Sample Size for Test Set: Not applicable in the context of human subjects or "test sets" as you might find in an AI/imaging study. The "test set" in this context refers to the samples used in bench testing (e.g., electrical safety tests, biocompatibility tests), the number of which is not specified in this summary.
• Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective studies, as no human clinical data is presented here to support the device's safety and effectiveness. The data provenance discussed relates to the manufacturer (Ace Medical Devices Pvt. Ltd., India) and the predicate device manufacturer (Olympus Winter & Ibe GmbH).

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

Not applicable. This is not a study involving expert review for establishing ground truth from patient data. The "ground truth" for this device's safety and effectiveness is established by its similarity to a device already on the market and its conformance to recognized engineering and safety standards.

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

Not applicable, as there is no "test set" in the context of human data requiring expert 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

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in that way.

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

Not applicable for the same reasons as above. This is an electrosurgical device, not an algorithm.

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

The "ground truth" for the substantial equivalence claim is multi-faceted:

• Predicate Device Performance: The primary ground truth is that the predicate device (Olympus K120418) has a history of safe and effective use in the market.
• Consensus Standards: Adherence to recognized consensus standards like IEC 60601-1 (electrical safety) and IEC 60601-2-2 (thermal safety), and ISO 14971:2007 (risk management).
• Bench Testing: Internal design verification testing results (not detailed here) that confirmed the device functions as intended and met acceptance criteria for engineering specifications.
• Biocompatibility Testing: Results indicating the materials are biocompatible.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable.

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The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific acceptance criteria. The document is an FDA 510(k) clearance letter for "Ophthalmoscopes Diagnostic Instrument Kits." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

The document does not contain details regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes or data provenance for any test sets
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm performance studies
• Type of ground truth used
• Sample size for training sets
• How ground truth for training sets was established

The letter primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.

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