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The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The Lucia has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency, The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The Lucia generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.

Here's a breakdown of the acceptance criteria and study information for the Lucia device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance data was presented which showed that skin temperature was elevated as required for this type of device." This suggests a test was conducted, but details are not included in this summary.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The study appears to be a technical performance evaluation (skin temperature elevation) rather than one requiring clinical interpretation needing expert consensus.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Given the nature of the stated performance data ("skin temperature was elevated as required"), it's likely a direct measurement rather than an expert-adjudicated outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. This type of study is more common for diagnostic devices where human interpretation is a key component. The Lucia is a therapeutic heating device.

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

The concept of "standalone" performance typically applies to AI algorithms. The Lucia is a physical infrared lamp device, so this question is not applicable in the traditional sense. The performance data would directly reflect the device's physical output.

7. The Type of Ground Truth Used

The ground truth for the "Performance data" was likely direct measurement of skin temperature elevation. The statement "skin temperature was elevated as required for this type of device" implies a quantitative measurement against predefined physiological or regulatory targets.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the Lucia is a physical medical device, not a machine learning model that requires a training set.

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

Since there is no mention of a training set (as the device is not an AI algorithm), this question is not applicable.

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The LAPEX BCS is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The LAPEX BCS has a hand-held treatment probe, is noninvasive, low level visible and infrared lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit. The LAPEX BCS generator operates automatic calculation of energy output in relation to set treatment parameters and the parameters(treatment time, output power delivered) can be adjusted by using key and treatment specifications and menus as well as treatment progressing are displayed on a LCD display in real time. And the LAPEX BCS generator operates simultaneous and independent management of outputs for connecting probes with laser sources of different wavelength. The LAPEX-BCS generator supplied with 2 completely independent outputs for using two treatment probes and simultaneously, even with laser sources of different wavelengths. The LCD displays operating parameters of both channels. 'This allows two operators to carry out laser therapy independently; just like having two separate instruments.

Here's an analysis of the provided text regarding the LAPEX BCS device, focusing on acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LAPEX BCS device, as described in the provided document, primarily relate to its ability to generate a specific skin temperature.

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

• Sample Size: 50 subjects.
• Data Provenance: The document states "50 subjects of various ages and races (Oriental, Black, and Caucasian)". This suggests it was likely a prospective clinical test conducted by Meridian Co., Ltd. The country of origin of the data is not explicitly stated beyond the company's location in Seoul, Korea. It is not specified as retrospective.

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

The document does not mention the use of experts or the establishment of ground truth by experts for the clinical testing. The study focuses on measuring the device's physical effect (skin temperature elevation) rather than expert interpretation of clinical outcomes for ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The study appears to be a direct measurement of skin temperature.

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

No MRMC comparative effectiveness study was mentioned. The study described focuses on the device's physical performance, not on how it assists human readers or improves their performance.

6. Standalone Performance Study

Yes, a standalone study was performed. The "clinical testing using thermography on 50 subjects" measured the device's ability to generate a specific skin temperature on its own. This is a standalone performance metric for the LAPEX BCS device.

7. Type of Ground Truth Used

The ground truth used in this context is the measured skin temperature. The acceptance criteria are based on achieving a specific, quantifiable physical change (temperature elevation) rather than an expert consensus, pathology, or direct patient outcomes (though pain relief is the ultimate intended use, the study provides a physiological basis for it).

8. Sample Size for the Training Set

No training set is mentioned. This device is an infrared lamp, not an AI or machine learning algorithm that typically requires a training set. The study described is a direct performance measurement.

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

Not applicable, as there is no mention of a training set or an AI/ML algorithm involved.

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The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The LAPEX-2000 is a low level laser therapy device.

This 510(k) submission (K034009) for the LAPEX-2000 low-level laser therapy device asserts substantial equivalence to predicate devices rather than providing a new clinical study with defined acceptance criteria and performance metrics. Therefore, many of the requested details are not available.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the submission. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the inherent safety and effectiveness standards of those previously cleared devices. There are no explicit acceptance criteria or reported performance metrics (like sensitivity, specificity, or improvement effect size) for the LAPEX-2000 itself in this document.

The comparison table provided focuses on technical specifications and intended use to show similarity to predicate devices:

The conclusion states that the device is "as safe and effective as the predicate device" based on "bench, electrical safety, EMC, and user testing data," but the details of this testing (acceptance criteria, performance results) are not elaborated upon.

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

Not applicable/Not provided. This submission does not include a clinical study with a "test set" in the context of device performance metrics. The mention of "user testing" is too vague to determine sample size or data provenance. The focus is on demonstrating technical equivalence and shared intended use with existing devices.

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

Not applicable/Not provided. As there is no clinical study with a test set requiring ground truth establishment, this information is not relevant to this submission type.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set requiring adjudication is described.

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

No. An MRMC study was not conducted or reported in this submission. The submission does not discuss human reader performance or AI assistance.

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

No. This device is a therapeutic laser, not an algorithm, so a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not provided. For a substantial equivalence claim, the "ground truth" is largely established by the regulatory clearance of the predicate devices for their indicated uses and the technical similarity of the new device. No specific ground truth type (like pathology or outcomes data) for a novel clinical study is detailed for the LAPEX-2000.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is hardware, not an AI/ML algorithm that requires a "training set."

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

Not applicable/Not provided. This information is not relevant for this type of device and submission.

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The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric plethysmography.

The McPulse Photo-Plethysmograph is intended to be used to measure pulse waveform and heart rate in the finger by lighting a fingertip with combination of infrared LED and photodiode. The measurement probe is an optoelectronic sensor consisted of a light-emitting diode(infrared LED) and a photodiode placed on opposite side as a light receiver. The light from the LED is transmitted through the tissue at the sensor site and a photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed. This device converts the changes of transmitted light from a photodiode into a waveform and displays a graphic display of the pulse waveform on LCD screen. Pulse rate is measured using the time between successive pulses and displayed digital values on LCD screen. The McPulse system consists of an optoelectronic sensor that is applied to the patient and a microprocessor-based system that processes and displays the measurement. The optoelectronic sensor contains a light-emitting diode(infrared LED) and one photodiode as a light receiver. The light from the LED is transmitted through the tissue at the sensor site. The photodiode in the sensor measures the transmitted light and this signal is used to determine how much light was absorbed.

The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on functional and safety aspects.

Here's a breakdown of the information that can be extracted or inferred, and points where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria or detailed performance results in the way one might expect for a clinical study comparing an AI system to a baseline. Instead, it offers a comparison of features to a predicate device.

Missing Information:

• Specific numerical acceptance thresholds for pulse waveform accuracy, heart rate accuracy, signal-to-noise ratio, or other relevant performance metrics.
• Quantitative results from "bench and user testing" that would show the McPulse's measured performance against these thresholds.

2. Sample size used for the test set and the data provenance:
The document mentions "bench and user testing." However, it does not specify:

• The sample size of participants or data points used in these tests.
• The provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "user testing" but does not provide any details about:

• The number of experts involved.
• Their qualifications.
• How ground truth was established, if applicable, in the context of this device (which measures physiological signals rather than interpreting images or complex diagnostic data).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Provided. The nature of this device (photoelectric plethysmograph measuring pulse/heart rate) typically doesn't involve adjudication methods like those used for image interpretation in AI studies.

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 not an AI-assisted diagnostic tool for human readers. It's a physiological monitoring device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measurement instrument. The "bench and user testing" would have evaluated its performance in this standalone capacity. However, no specific details or results of these tests are provided beyond a general statement of equivalency.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a device measuring pulse waveform and heart rate, ground truth would typically be established by:

• Bench testing: Using calibrated signal generators or phantoms to simulate physiological signals with known characteristics.
• User testing: Comparing the device's measurements to a gold standard reference device (e.g., an ECG for heart rate, or a highly accurate plethysmograph) on human subjects.
  The document does not specify which methods were used for "bench and user testing" to establish ground truth for this device.

8. The sample size for the training set:
Not applicable. This device is a hardware-based physiological monitor, not a machine learning algorithm that requires a "training set" in the common sense of AI development.

9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" described for an AI model.

Summary of the Study:

The document describes a 510(k) submission for the "McPulse Photoelectric Plethysmograph" seeking substantial equivalence to the Novametrix Pulse Oximeter, Model 500 (K853124). The "study" proving the device meets its (largely inferred) acceptance criteria is described as "bench and user testing."

The conclusion is a qualitative statement: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." It further states that the McPulse is "as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

While the document confirms that testing was performed, it lacks the specific quantitative details regarding sample sizes, expert qualifications, ground truth methodology, and performance metrics that would typically be expected for a detailed description of acceptance criteria and a proving study in the context of more complex diagnostic devices or AI systems.

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The ABR-2000 intended use is for the meas orement of galvanic skin response.

Not Found

The provided text describes a 510(k) premarket notification for the ABR-2000, a Galvanic Skin Response Measurement device. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety standards. It does not contain information about a study proving the device meets specific acceptance criteria related to its performance in measuring galvanic skin response, nor does it detail a study that would include the specific elements requested (e.g., sample size for test set, ground truth methods, MRMC studies, standalone performance).

Therefore, based on the provided text, I cannot complete a table of acceptance criteria versus reported device performance relevant to the measurement of galvanic skin response, nor can I provide information on sample sizes, ground truth establishment, or multi-reader studies.

The document indicates:

• Substantial Equivalence: The ABR-2000 is considered substantially equivalent to the MERIDIAN-II and MERIDIAN-Plus devices. This is the primary "acceptance criterion" in the context of a 510(k) submission where direct performance data might be deferred if equivalence to a legally marketed device is established for the same intended use.
• Electrical Safety: The device meets electrical safety requirements as per EN 60601-1 (IEC 601-1) and EN 60601-1-2. This is a safety-related acceptance criterion.

Based on the provided text, the specific information requested about a performance study is not available. The document focuses on regulatory compliance for electrical safety and substantial equivalence for its intended use, rather than a detailed performance study proving specific clinical or technical acceptance criteria for galvanic skin response measurement.

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