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PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.

The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test.

The provided text is a 510(k) summary for the PS-2100 device, which is a Sensory Nerve Threshold Measurement System. This document focuses on demonstrating substantial equivalence to a predicate device (NEUROMETER K853608) rather than presenting a detailed clinical study for acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted from this document. The document lists the device's indications for use and general information but does not contain the specifics of a clinical validation study with performance metrics, sample sizes for test or training sets, expert qualifications, or comparative effectiveness.

Here’s what can be inferred or directly stated from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. The document is a 510(k) summary focused on substantial equivalence, not a clinical study report.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: An MRMC comparative effectiveness study is not mentioned in this document. The focus is on demonstrating substantial equivalence to a predicate device, which usually involves comparing technical characteristics and indications for use, rather than a direct comparison of human performance with and without the device.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study is detailed.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: Not explicitly described as a performance study in the context of clinical metrics. The document mentions a "Standalone mode by which the device itself is used for measurements," but this refers to the operational mode of the device without a connected computer, not an algorithm-only performance study in the regulatory sense. The device measures "Current Perception Threshold" (CPT), which is a direct physiological measurement, not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified in relation to a performance study. The device measures the "Current Perception Threshold (C.P.T.) value," which itself could be considered a form of "ground truth" for sensory perception at a given point in time, but the document does not describe how this would be validated against an independent, objective ground truth for clinical performance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The PS-2100 is described as a "Sensory Nerve Threshold Measurement System" that applies an electrical stimulus and measures the C.P.T. value. This is a direct measurement device, not an AI/ML-based algorithm that would typically require a training set.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

In summary, the provided document is a regulatory submission (510(k) summary) aiming to establish substantial equivalence for the PS-2100 device. It does not contain the detailed information typically found in a clinical study report that would describe acceptance criteria and performance data for a device, especially not for an AI/ML system.

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The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.

The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.

The provided text describes a 510(k) premarket notification for the Xilas Medical VPT Meter, which is a vibration threshold measurement device. However, the document does not contain explicit acceptance criteria, detailed study designs, or comprehensive performance data in the format requested.

The text focuses on establishing substantial equivalence to a predicate device (Vibrameter, Somedic AB) by comparing design, functionality, and intended use. While it mentions "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious," it does not provide the specifics of these tests.

Therefore, much of the requested information cannot be extracted directly from the provided document. I can only report what is implicitly stated or where there is a lack of information.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:

• Safety: Implicitly, the device must be safe for human use. (Specific criteria not provided)
• Efficacy: Implicitly, the device must be efficacious in measuring vibration perception threshold. (Specific criteria not provided)
• Substantial Equivalence: The device must demonstrate similar intended use, characteristics, and performance to the predicate device, the Vibrameter. (Specific performance metrics for equivalence not provided)

Reported Device Performance:
The document states that "Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious." However, it does not provide any quantitative or qualitative data on how this safety and efficacy were demonstrated, nor does it present specific performance metrics like sensitivity, specificity, accuracy, or agreement with a gold standard. The primary performance assertion is that it is substantially equivalent to the predicate device.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Testing of the device (included with this submission)," but the sample size of subjects or data used in these tests is not provided.
• Data Provenance: Not explicitly stated.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

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

• MRMC Study: Not mentioned. The document focuses on device-to-predicate comparison rather than human reader performance with/without AI assistance. The device itself is a measurement tool, not an AI diagnostic aid for human readers.
• Effect Size: Not applicable as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Study: The device itself is a standalone measurement instrument. The document implies its performance was evaluated to ensure safety and efficacy, and substantial equivalence, but detailed "standalone performance" metrics (like accuracy against a true vibratory threshold) are not provided. The comparison made is against another device (the predicate), not an absolute ground truth.

7. Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated. For a vibration perception threshold device, ground truth would ideally be derived from a highly accurate, perhaps laboratory-grade, reference vibratory stimulus or established clinical benchmarks. The document's closest mention to a "ground truth" is the comparison to the predicate device, implying that the predicate's measurements serve as a reference for equivalence, but not necessarily a "true" physiological ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

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The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The Medi-Dx 7000 diagnostic examination may be conducted as part of a routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.

The Medi-Dx 7000 is a Current Perception Threshold (CPT) device for the examination of peripheral neuropathies. It generates a sinusoidal electrical currents in the 5 Hz, 250 Hz and 2000 Hz frequencies from 0 mA to 9.99 mA.

The Medi-Dx 7000 weighs approximately 15 lbs. and is housed within a 12" x 6" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately below an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes (which are not provided with the unit and are ordered by the user from suppliers mentioned in the owners manual).

Here's an analysis of the provided text regarding the Medi-Dx 7000, focusing on acceptance criteria and the supporting study, based on your requested categories.

It's important to note that the provided text is a 510(k) summary (or a letter related to an older 510(k) submission), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials for new device performance. As such, many of your requested points regarding a clinical study or performance metrics won't be fully addressed, as the submission appears to rely heavily on the equivalence of technical specifications.

Acceptance Criteria and Study for Medi-Dx 7000

Based on the provided 510(k) summary, formal acceptance criteria and a structured study to prove the device meets these criteria in the way a modern AI/software device would be evaluated are not presented. The submission primarily establishes substantial equivalence to a predicate device (Neurometer by Neurotron) based on technical similarities and safety improvements, implying that if the predicate device is safe and effective, the Medi-Dx 7000, being "essentially the same" in function and reliability, also is.

Here's an attempt to populate the table and answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) for diagnosing neurological impairments. Instead, the "acceptance" is implicitly tied to its functional equivalence and safety compared to the predicate device.

• Minimum/maximum output (0.0 mA to 9.99 mA)
• Current characteristic (sinusoidal waveform)
• Frequencies (5 Hz, 250 Hz, 2000 Hz) |
  | Safety - Absence of RFI | The Medi-Dx 7000 "produces no RFI" due to four independent clocks for frequency production, unlike the predicate device (which uses one crystal-controlled clock and produces RFI). |
  | Safety - Output Isolation | The Medi-Dx 7000 has "isolated output via the transformer," whereas the equivalent device "depends on non-failure of the charger and selector switch to prevent 110v AC leakage." |
  | Safety - Case Material | The Medi-Dx 7000 case is "largely non-conducting plastic," providing a safety advantage over the equivalent device's "all metal case." |
  | Safety - Electrical Field Build-up (No-load conditions) | "No-load conditions will not build up an electrical field at the electrodes, because the output is dampened." It is unknown if the predicate device has this feature. |
  | Safety - Power Supply Disconnect | The Medi-Dx 7000 has a "safety interlock which disconnects the power supply if the case is opened." (Not mentioned for predicate) |
  | Safety - Low Battery Warning | The Medi-Dx 7000 "WARNING" light flashes if power drops below that needed to supply max output. (Predicate device has a "steady on" warning for low batteries and a flashing warning for waveform clipping at intensity increase, or flashing at zero for low battery). |
  | Operational Control | The Medi-Dx 7000 is "fully manually controlled." (Predicate has manual and auto-test modes). The manufacturer contends manual control avoids "over-stimulation." |
  | Accuracy/Calibration | Both devices "manufacturers 'burn in the devices for 168 hours and testing insures accuracy/calibration." |
  | Indications for Use (same as predicate) | "Quantitative detection of sensory neurological impairments" in individuals capable of communicating cutaneous sensation, as part of routine neurological examination or screening for peripheral neuropathy. |

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

• Test Set Sample Size: Not applicable/Not mentioned. There is no mention of a formal "test set" of patients or data used to evaluate the device's performance in diagnosing neurological impairments. The submission relies on technical comparisons to a predicate device.
• Data Provenance: Not applicable.

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

• Number of Experts: The document mentions that the manufacturer "has consulted with" neurologists and other medical experts regarding the auto-test mode and its potential to alter thresholds. Several of these physicians "have compared the devices clinically and have agreed to share their opinions if contacted." However, this is not presented as a formal consensus-building process for establishing ground truth on a test set.
• Qualifications of Experts: "Neurologists and other medical experts." No specific experience levels are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not mentioned. There was no formal test set requiring adjudication.

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

• MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance (as this is an older, non-AI device). The "clinical comparison" by a "several physicians" mentioned is not formal enough to be considered an MRMC study.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: The Medi-Dx 7000 is a hardware device; it does not contain a complex algorithm or AI that would require a "standalone" performance study in the modern sense. Its function is to generate electrical currents and measure perception thresholds, which directly involve human interaction. The performance of the device itself in terms of output accuracy and stability is "insured" by manufacturing tests (burn-in and calibration).

7. Type of Ground Truth Used

• Type of Ground Truth: The concept of "ground truth" for diagnostic performance (e.g., against pathology or clinical outcomes) is not discussed for the Medi-Dx 7000's diagnostic capabilities. The submission implies that the functionality of the device (generating currents at specific frequencies and intensities) is equivalent to the predicate, and therefore its utility in detecting sensory neurological impairments is assumed to be similar to the established utility of the predicate device. The only "truth" mentioned is the opinion of "neurologists and other medical experts" regarding the theoretical advantage of manual testing over auto-test mode to avoid receptor fatigue.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not mentioned. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Document's Approach:

The 510(k) submission for the Medi-Dx 7000 primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (Neurometer). This means the manufacturer largely argues that because their device is similar in intended use and technological characteristics to a device already deemed safe and effective by the FDA, it should also be considered safe and effective. The emphasis is on showing that any differences are either minor or lead to improved safety (e.g., RFI reduction, better isolation, non-conducting case). There is no detailed clinical study with performance metrics for diagnosis presented, as is common for many Class I and II devices seeking substantial equivalence where the technology is well-understood.

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The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.

The AP-4000, Air Pulse Sensory Stimulator, is an endoscopic accessory that must be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-(Laryngo) Scopes. The AP-4000 is a software controlled device. The device contains an Air Pump and the mechanics to control the pressure of a 5 0 millisecond (ms) air pulse, delivered through the FNL-10AP working channel. The device is connected to the endoscope working channel with an Air Supply Tube (two pieces are included with the device as standard set components). The device front panel has controls and displays to allow a desired pressure for the 50 ms air pulse to be selected (in the range 2 mm Hg to 10 mm Hg), the air pulse to be initiated, and the actual pressure of the delivered air pulse to be displayed. There are connections for the Air Supply Tube (to the endoscope working channel), a pneumatic footswitch (alternate control to initiate air pulse, one piece is included as a standard set component), and an RS-232 connection so that unit displays may be available to other system peripheral devices (Addon Camera).

The provided document is a 510(k) summary for the AP-4000, Air Pulse Sensory Stimulator. It describes the device, its intended use, and comparison to predicate devices, but does not include any information regarding acceptance criteria or a study proving the device meets said criteria.

The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that no clinical study was performed or submitted for this specific 510(k) clearance process to demonstrate performance against acceptance criteria.

Therefore, I cannot provide the requested information for the following sections based on the input document:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate devices based on design, specifications, and intended use, rather than presenting a performance study with defined acceptance criteria.

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For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.

The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.

The provided text describes a 510(k) premarket notification for the VSA 3000 Vibratory Sensory Analyzer. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results to establish acceptance criteria and performance. Therefore, much of the requested information regarding acceptance criteria, specific study design, and statistical outcomes is not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity, accuracy). The acceptance criteria for a 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed predicate device.
• Reported Device Performance: The document describes the functionality and purpose of the device, but does not provide quantitative performance metrics (e.g., specific accuracy, precision, or diagnostic yield values).

What the document does state regarding performance/equivalence:

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

• Not provided. The 510(k) summary does not contain information about a specific test set or clinical study with a defined sample size for the VSA 3000 itself. The focus of the 510(k) is on comparing the device to existing predicates rather than presenting novel clinical performance data.

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

• Not provided. This information would typically be part of a clinical study report, which is not included in this 510(k) summary.

4. Adjudication Method for the Test Set:

• Not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where multiple readers or experts independently assess cases, typically for diagnostic accuracy. This information is not present.

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

• No indication of an MRMC study. The document does not mention any study comparing human readers with and without AI assistance, nor does it quantify an effect size for such a comparison. The VSA 3000 is described as a device for "measurement of vibratory thresholds," which implies a direct measurement tool rather than an AI-assisted diagnostic aid for human readers.

6. Standalone Performance Study (Algorithm Only):

• No indication of a standalone performance study in the context of an algorithm's diagnostic accuracy. While the device itself performs measurements, the document does not present data from a "standalone" study in the sense of an algorithm's diagnostic performance without human-in-the-loop, as would be typical for AI/ML devices. The device is a standalone vibrating sensory analyzer, but its performance is described in terms of its function and equivalence, not as an algorithm's diagnostic output.

7. Type of Ground Truth Used:

• Not provided. For a device that measures vibratory thresholds, the 'ground truth' would implicitly be the actual vibratory sensation perceived by the patient, often correlated with clinical diagnoses of neuropathy. However, the exact methodology for establishing this in a formal study is not detailed.

8. Sample Size for the Training Set:

• Not applicable / Not provided. The VSA 3000 is a measurement device, not an AI/ML system that would typically have a "training set" in the context of machine learning model development.

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

• Not applicable / Not provided. As above, the concept of a "training set" ground truth as applied to AI/ML is not relevant here.

In summary: The provided document is a 510(k) substantial equivalence letter and summary. It focuses on demonstrating that the VSA 3000 is similar in indications for use, technology, and safety/effectiveness to predicate devices (Bio-thesiometer, Vibraton II, Case IV) that were already legally marketed. It does not contain the detailed clinical study data, acceptance criteria, or performance metrics typically found in documents for devices requiring de novo clearance or a PMA, especially those involving AI/ML. The "study" here is the assertion and argument for substantial equivalence, rather than a clinical trial proving specific performance against predefined statistical targets.

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