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The Xrecovery is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

The Xrecovery is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.

The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The device is intended to be used with Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the cold- compression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional

This document is a 510(k) summary for the Xrecovery (XR-001), a powered inflatable tube massager. The information provided focuses on demonstrating substantial equivalence to a predicate device (Polar Care Wave, K183702), rather than detailing a study that proves the device meets specific acceptance criteria for a new and novel AI-enabled medical device.

Therefore, many of the requested elements for an AI-specific study are not present in this document. This device is a traditional medical device, not an AI-enabled one.

However, I can extract the general acceptance criteria and performance data for this physical medical device and explain why specific AI-related details are missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

The document primarily relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" are implied by the ability to meet relevant performance standards and demonstrate comparable technological characteristics to the predicate.

AI-Specific Study Details (Not Applicable for this Device)

The Xrecovery (XR-001) is a physical medical device (Powered Inflatable Tube Massager) that performs cold and compression therapy. It is explicitly described as "AC powered, software controlled." The software controls the pumps and therapy settings but there is no indication it uses AI, machine learning, or performs any diagnostic or predictive functions that would necessitate the in-depth AI-specific study details requested.

Therefore, the following points are not applicable (N/A) based on the provided document:

1. Sample size used for the test set and the data provenance: N/A as no AI/ML model for diagnostic/predictive tasks is described. The device underwent general performance, electrical safety, biocompatibility, and software V&V testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment for medical imaging or AI diagnostic output is not relevant for this device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A. This is a non-AI therapeutic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device's performance relates to its physical parameters (e.g., temperature, pressure, electrical safety, biocompatibility) rather than diagnostic accuracy.
7. The sample size for the training set: N/A. No AI model is described.
8. How the ground truth for the training set was established: N/A. No AI model is described.

In summary, the provided FDA 510(k) summary is for a traditional, software-controlled physical therapy device, not an AI-enabled medical device. As such, the study details requested for AI performance are not part of this submission. The "study" described in the document primarily consists of non-clinical bench testing, biocompatibility testing, electrical safety and EMC testing, and software verification and validation, all aimed at demonstrating that the device is as safe and effective as its predicate.

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Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.

The provided text is a 510(k) Summary for a medical device called "Cold Compression". This document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a study of its performance in a clinical or analytical setting.

Therefore, the input document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that "Clinical testing was not needed in support of this 510(k) application." (Section 8) and focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests for electrical safety and electromagnetic compatibility.

Instead, the document provides:

Non-Clinical Tests Performed:

• Tests: Non-clinical tests were performed to validate the design and assure conformance with voluntary design standards related to medical device electrical safety and electromagnetic compatibility.
• Standards:
  • IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
  • IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

Comparison Table (Table 1):
This table compares the subject device ("Cold Compression") with two predicate devices (K223541 and K183702) across various technical characteristics and specifications to establish substantial equivalence. While it doesn't present "acceptance criteria" in the traditional sense of a performance study, it details the characteristics where the device's performance parameters are deemed acceptable due to their similarity to a legally marketed device.

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Cold/Hot Compression combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated.

Cold/Hot Compression also provide DVT therapy. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

ColdHot Compression is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

The subject device is a prescriptive device, which combines cold/hot therapy and air compression. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold) are indicated. It is intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

The subject device comes with the thermal-therapy wraps and the DVT wraps. The thermal-therapy wrap is nylon fabric on one side and velvet cloth on the other side; the DVT wrap is velvet on both sides. To avoid any potential adverse skin reactions such as redness, irritation, and cold/hot injury, the sock/clothing should be worn by the patient prior to use.

The subject device includes a main device and an optional DVT device, and has a limited shelf life of 3 years, based on the charge retention characteristics of the device's battery.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the typical sense.

Therefore, the information requested might not be fully available or explicitly stated in the provided text as it would be in a clinical study report.

Based on the provided text, here's what can be extracted and inferred:

1. Table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" here is primarily tied to demonstrating equivalence to the predicate device. The performance is assessed by comparing technical specifications.

Notes on Equivalence (as explained in the document):

• Note 1 (Cold Therapy): The subject device's cold therapy temperatures are within or similar to the range of the predicate/reference devices, and are adjustable by professionals. Differences are considered insignificant and do not raise new safety/effectiveness concerns.
• Note 2 (Heat Therapy): Similar to cold therapy, the heat therapy temperatures are within or similar to the predicate/reference devices and adjustable. Differences are insignificant.
• Note 3 (Edema Pressure): The subject device's lowest pressure is within the predicate's range and similar to the reference. The highest pressure is slightly higher but still adjustable by professionals. Differences are insignificant.
• Note 4 (DVT Pressure): The subject device's DVT pressures for calf and foot fall within or are slightly higher than the predicate/reference devices. Differences are insignificant.
• Note 5 (Cycle Length): The subject device's longest cycle length is similar to or longer than the predicate's, though shorter than the reference. Cycle length is adjustable. Differences are insignificant.
• Note 6 (Contrast Therapy Temp): The subject device's contrast therapy temperatures are either similar to the predicate or identical to the reference. No new safety/effectiveness issues.
• Note 7 (Contrast Cycle Length): The contrast therapy cycle length is slightly different from the predicate but identical to the reference. No new safety/effectiveness issues.
• Note 8 (Reservoir Fluid Capacity): The subject device's capacity is smaller than the predicate's but larger than the reference's. This difference does not raise new safety/effectiveness issues.

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

The document explicitly states: "Clinical testing was not needed in support of this 510(k) application."

Therefore, there is no test set in the sense of patient data from a clinical study. The "testing" involved non-clinical bench tests and comparison of specifications to predicate devices. The data provenance is from internal JKH Health Co., Ltd. testing and comparison to publicly available predicate and reference device information.

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment for a patient-based diagnostic or therapeutic outcome.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring 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 a physical medical device (Cold/Hot Compression unit), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests would be the measured physical parameters of the device (e.g., actual temperature output, actual pressure levels, cycle times) against the device's design specifications and the specifications of the predicate devices. For safety standards, the ground truth is adherence to the requirements of the standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design was likely based on engineering principles and comparison to existing devices.

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

Not applicable. No training set was used.

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The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling. inflammation, and hematoma from minor surgical procedures.

The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.

The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dermal Cooling System:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Information about the Study:

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

The document states, "No other performance testing was performed for the subject device for this Traditional 510(k)..." and "No preclinical or clinical testing was performed." The only reported test is a "System Performance Test" described as "Bench testing." This implies the "test set" for this specific performance criteria was likely a single or a small number of physical devices tested in a lab setting, rather than a clinical dataset. No information on data provenance (country of origin, retrospective/prospective) is applicable as it's not a clinical study involving patient data.

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

Not applicable. The reported test is a bench test, and the "ground truth" is established by the device's ability to maintain a specific coldplate temperature, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set:

Not applicable, as it's a bench test against an objective temperature criterion.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No preclinical or clinical testing was performed."

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

This question is not applicable to the Dermal Cooling System. This device is a physical cryosurgical instrument, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not relevant.

7. The Type of Ground Truth Used:

The ground truth for the "System Performance Test" was the pre-defined target temperature range for the internal coldplate (-16.0°C ± 0.5°C) maintained over a specific duration (20 minutes). This is a physical performance specification, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable, as there is no training set mentioned or implied.

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The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.

Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.

Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.

The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.

The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

This document, K213097, is a 510(k) premarket notification for a medical device called Armory Motion, which provides cold and compression therapy. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Breg Polar Care Wave, K183702).

The provided text does not contain detailed acceptance criteria for a study demonstrating detailed device performance against specific metrics using a test set of data with established ground truth. Instead, the "study" demonstrating the device meets acceptance criteria is primarily a comparison with a predicate device and adherence to recognized consensus standards.

The document states:

• "No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission."
• "Test results, Risk Analysis, and FMEA analysis show that the new device Armory Motion is safe with no hazard."
• "The new device Armory Motion is designed to comply with relevant safety applicable recognized consensus standards."
• "The output characteristics of Armory Motion are similar to those of predicated device, see Table below."

Given this information, it's clear that a typical "study" proving performance against quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or reader agreement for an AI/diagnostic device (as implied by the detailed questions) was not conducted or presented in this 510(k). The device is a therapeutic device, not a diagnostic one.

However, I can extract the information provided to address your points as best as the document allows, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on technical specifications and safety standards, rather than direct performance metrics against a clinical outcome or diagnostic accuracy.

Here's a breakdown based on the provided text:

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

The document establishes "acceptance criteria" through comparison to the predicate device and compliance with recognized standards. Performance is reported through a comparative table.

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

• Sample Size: Not applicable as no formal clinical or performance study with a "test set" of data for diagnostic evaluation was performed. The "test set" in this context is the device itself being compared to the predicate device's specifications and standards.
• Data Provenance: Not applicable. The "study" is a technical comparison and demonstration of compliance with standards.

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

• Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert reads, pathology) was not established because no such study was conducted. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the relevant consensus standards.

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

• Not applicable. No expert adjudication process for a test set was performed.

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/diagnostic assistant for human readers.

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

• Not applicable. This is a physical therapeutic device, not a standalone algorithm. Its performance is inherent in its design and operation.

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

• The "ground truth" for this 510(k) submission is the established safety and performance of the predicate device (Breg Polar Care Wave, K183702) and compliance with recognized consensus standards (listed in the document, e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, etc.).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. No training set was used.

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The Polar Care Wave System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

The Polar Care Wave system is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently. The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device. The device is intended to be used with Breg Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual-bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy. The insulated container is filled with ice and water by the user. The water circulates through the cold-compression pad to deliver cold therapy to the application site. The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

The provided text is a 510(k) Summary for the Breg Polar Care Wave system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics as would be typical for a novel device or a device requiring de novo classification.

The document discusses performance testing in a general sense, stating:

• "The Polar Care Wave System has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the system."
• "The Polar Care Wave device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment."
• "The labeling materials have been found to be easy to use and understandable to the intended users."
• "The software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use."

However, it does not provide a table of specific acceptance criteria, reported device performance (quantitative metrics like sensitivity, specificity, accuracy, etc.), or details of a clinical study in the way medical AI or diagnostic devices typically require. Instead, the focus is on engineering and safety standards compliance (e.g., IEC 60601) and comparison of features to predicate devices.

Therefore, for the information requested regarding acceptance criteria and a study proving performance, this document does not contain the specific details you've asked for, such as:

• A table of acceptance criteria and reported device performance.
• Sample size used for a clinical test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or human reader improvement data.
• Standalone algorithm performance.
• Type of ground truth used (clinical outcomes, pathology, expert consensus).
• Sample size for training set or how ground truth was established for it.

The primary study detailed here is a comparison to predicate devices, focusing on demonstrating similarities in intended use, technology, and compliance with general safety standards, leading to a conclusion of substantial equivalence.

Based on the provided text, here is what can be inferred or explicitly stated regarding performance, albeit without the detailed clinical study metrics you requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Implied, not explicitly quantified as typically done for AI/diagnostic devices): The device functions as intended, providing cold and compression therapy safely and effectively within specified ranges, and meets relevant electrical safety and EMC standards. It is "adequately safe and effective" and its labeling is "easy to use and understandable."
• Reported Device Performance (Qualitative, not quantitative clinical metrics from the document):
  • "The Polar Care Wave System has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the system."
  • "The Polar Care Wave device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment."
  • "The software in the Polar Care Wave system has been validated and demonstrated to be safe and effective for its intended use."
  • Therapy Temperature Range: 45°F-60°F (falls within the range of predicate devices).
  • Compression Setting: Low (0-25 mm Hg), Regular (0-50 mm Hg). The high pressure is within the predicate device range, and low pressure being lower is noted as having no safety/effectiveness issues as it represents minimum pressure.
  • Compliance: Certified to IEC 60601-3rd edition (medical electrical safety) including ANSI/AAMI/ES60601-1-11, and IEC 60601-1-2 4th edition (EMC).

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

• Not provided. This document does not describe a clinical test set with a specific sample size of patients or images. The "testing" mentioned refers to design verification and validation, likely internal engineering tests, not a clinical trial on a patient cohort specified by sample size.
• Data Provenance: Not applicable in the context of a clinical test set for performance evaluation in this document.

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

• Not applicable. The submission does not detail a clinical study where human experts established ground truth for a test set. The validation is based on engineering and safety standards, and functional verification.

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

• Not applicable. No clinical test set and associated ground truth adjudication described.

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

• No. This is a physical therapy device (cold and compression), not an AI/diagnostic imaging device. Therefore, MRMC studies and concepts of "human readers improving with AI assistance" are not relevant to this submission.

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

• Not applicable. This is not an algorithm or AI device. Its performance is inherent to its mechanical and electrical function.

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

• Not applicable in the clinical sense. For a device like this, "ground truth" would be the engineering specifications and clinical indications for which cold and compression are generally accepted therapies (e.g., reduction of edema, swelling, and pain). Performance is established by meeting design specifications and safety standards, rather than direct comparison to a "ground truth" diagnosis.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device, so there is no training set in that context.

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

• Not applicable. See point 8.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a physical therapy device (Polar Care Wave) to existing predicate devices. It relies on engineering verification and validation, compliance with recognized safety and electrical standards (IEC 60601 series), and a comparison of functional features to establish that the device is "adequately safe and effective" for its intended use, rather than presenting a clinical study with quantitative performance metrics (like sensitivity/specificity) against a clinically established ground truth, which would be typical for AI-driven or diagnostic technologies.

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A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and/or apply heat and cooling to the skin.

The Dynatron Peltier ThermoStim probe is used to provide therapeutic electrical stimulation and thermal therapy treatments. The probe consists of a handle with a treatment head and connections to a Dynatron Solaris series controlling console for power and communications with a port for connection to electrical stimulation outputs. The probe acts as an electrode for therapeutic electrical current provided by a Dynatron Solaris device in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) supplied from a thermo-electric chip. The probe is a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatron Solaris series electrical stimulation devices. The probe has a rectangular wedge treatment face of approximately 1¼³ x 2¼" with rounded edges. The maximum surface area that could come in contact with a patient is approximately 38 cm-.

The provided text serves as a 510(k) summary for the Dynatron Peltier ThermoStim device, which is a combination electrical stimulation and thermal therapy probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the manner typically found in a clinical trial.

Therefore, the requested information, particularly regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and comparative effectiveness data with human readers, is not present in the provided document. The document primarily describes the device's technical specifications and compares them to a predicate device to establish substantial equivalence for regulatory approval.

However, I can extract the general performance characteristics and the basis for the declaration of substantial equivalence, which can be interpreted as implicitly meeting regulatory acceptance.

Here's what can be inferred from the document:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, "acceptance" is implicitly based on demonstrating that the Dynatron Peltier ThermoStim probe performs "equivalently" to the predicate device, Dynatron ThermoStim probe (K120835). The performance characteristics are compared in relation to the predicate's known performance.

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

The document mentions "Non-clinical Bench Testing" and "Thermal data was collected." However, it does not specify the sample size of devices tested or the number of measurements taken for either the electrical stimulation waveform analysis or the thermal data collection. The data provenance is implied to be from Dynatronics' internal testing ("Non-clinical Bench Testing"), likely in the USA where the company is located. The nature of the testing (bench testing) is prospective for these measurements.

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

This information is not provided. The device is purely a physical therapy accessory and likely does not involve diagnostic interpretation by experts for its core function. The "ground truth" for the performance tests (waveform analysis, temperature measurements) would be established by calibrated measurement equipment, not expert opinion.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data and their disagreements need resolution. Since this document describes bench testing of a physical device, such adjudication methods are not relevant.

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

This information is not provided and not applicable. The Dynatron Peltier ThermoStim is a physical therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are outside the scope of this device.

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

This information is not applicable. The device is a physical therapy probe that inherently requires human-in-the-loop operation by a practitioner. There is no "algorithm only" performance to evaluate in this context.

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

For electrical stimulation waveform analysis: Comparison against expected, known waveforms from the predicate device and the controlling Solaris console. The "ground truth" is the established electrical signal parameters.
For thermal data: Calibrated temperature measurements. The "ground truth" is the actual measured temperature by sensors.
For safety standards: Compliance with international safety standards (EN60601-1, EN60601-1-2). The "ground truth" is adherence to these normative standards.

8. The sample size for the training set

This information is not provided and not applicable. The Dynatron Peltier ThermoStim probe does not utilize machine learning or AI models that require a "training set" of data.

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

This information is not provided and not applicable as there is no training set for this type of medical device.

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A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin

The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.

The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.

There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).

This document describes the Dynatron ThermoStim Combination Electrical Stimulation and Thermal Therapy probe and its substantial equivalence to predicate devices, rather than a clinical study establishing its performance against acceptance criteria in the manner requested.

However, based on the provided text, I can extract and infer information relevant to your request regarding acceptance criteria and performance, primarily from the "Performance Characteristics" and "Non-clinical Bench Testing" sections.

The device is intended to provide therapeutic electrical stimulation and thermal therapy (hot and cold). The "acceptance criteria" here are implied by the desired therapeutic ranges and the device's ability to deliver these. The study described is a non-clinical bench test comparison.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "two body parts per patient" for the thermal data collection. There is no explicit number of patients or total "test set" samples (e.g., number of probes tested, number of measurements taken for waveforms, or number of patients if clinical). The electrical waveform analysis compares the ThermoSTIM probe to a predicate, implying at least one of each was tested.
• Data Provenance: Non-clinical bench testing. No country of origin is specified, but the submission is to the U.S. FDA by a U.S. company. The testing is retrospective in the sense that it evaluates the manufactured device; it is not a prospective clinical trial.

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

• This document describes non-clinical bench testing. Therefore, "ground truth" is established by measurement instruments (e.g., oscilloscopes, thermometers) and engineering standards (EN60601-1, EN60601-1-2). No human experts are explicitly mentioned for establishing a ground truth for the test set beyond the engineering team conducting the tests and interpreting the instrument readings against specified criteria.

4. Adjudication Method for the Test Set

• Not applicable as it's non-clinical bench testing involving objective measurements against defined engineering standards and electrical/thermal targets. There is no human subjective assessment or adjudication process described.

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

• No, a MRMC comparative effectiveness study was not done. This document primarily focuses on demonstrating substantial equivalence through non-clinical bench testing, comparing the new device's technical performance characteristics to existing predicate devices and safety standards. There is no mention of human readers or AI assistance in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a manual therapy accessory that requires a human practitioner to apply it. It is not an algorithm-only device or an AI system. The "standalone" performance here refers to the device's ability to deliver electrical and thermal energy as designed, which was evaluated in the bench tests.

7. The Type of Ground Truth Used

• The ground truth for the non-clinical bench testing was primarily objective physical measurements (electrical waveforms, temperature readings) compared against engineering specifications and regulatory standards (e.g., EN60601-1, EN60601-1-2).

8. The Sample Size for the Training Set

• This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply. The device's design and manufacturing processes are refined through engineering development and testing.

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

• As above, this is not an AI/ML algorithm, so there is no "training set" or establishment of ground truth for a training set in that context. The device's "training" or development involves iterative design, prototyping, and engineering validation to meet design specifications and regulatory requirements.

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This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

COOLSKIN is a 14" by 16" by 2 ¾ ft, 66 lb thermo-cooling mobile device that applies controlled cooling in the range of 3 degrees F to 50 degrees F (-16 degrees C to 10 degrees C) at skin surface in order to decrease skin temperature via a probe which is in direct contact with the skin surface. The device operates by semiconductor using Peltier principle. While the proximal side (towards the skin surface) gets cold, the distal side gets hot. The hot side is cooled by a water cooling system, which runs to the probe tip via a water circulating tube, and cools it. The warm/hot water is channeled away to the main unit where it is cooled via a fan. The probe is available in small and large versions.

This document does not contain the information required to fulfill the request. The provided text is a 510(k) summary for a skin cooling device (COOLSKIN), which primarily focuses on establishing substantial equivalence to a predicate device. It does not include details about acceptance criteria, a specific study proving those criteria were met, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document states:

• "COOLSKIN is safe and effective as the predicate device cited above."
• "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...".

This indicates the device's clearance was based on demonstrating equivalence, not necessarily on a detailed performance study with defined acceptance criteria as described in the prompt's requirements.

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The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable.

Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.

The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points, which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point).

The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy.

The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate.

The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.

The provided text describes the T-Pump Localized Temperature Therapy Pump (K073675) and its regulatory submission, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) summary and approval letter from the FDA. Its primary purpose is to demonstrate "substantial equivalence" to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.

The information sought in your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set size and ground truth establishment) is typically found in design validation reports or clinical study reports, which are part of the detailed submission to the FDA but are not usually included in the publicly available 510(k) summary.

Therefore, I cannot provide the requested table and details based solely on the provided text.

Here's a breakdown of why the information is not present and what is mentioned:

• Acceptance Criteria & Reported Performance: Not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish equivalence.
• Sample Size (Test Set) & Data Provenance: Not mentioned for any specific performance test.
• Number of Experts, Qualifications, Adjudication Method: Not applicable as no specific test set or ground truth establishment process is described beyond the general device description.
• MRMC Comparative Effectiveness Study: Not mentioned. The 510(k) pathway for this device typically relies on demonstrating equivalence rather than conducting a full comparative effectiveness study with human readers/users.
• Standalone Performance Study: Not mentioned in terms of quantitative performance metrics, sensitivity, specificity, accuracy, etc. The document describes the device's technical specifications and intended function.
• Type of Ground Truth: Not mentioned.
• Sample Size (Training Set): Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires training data in the same way.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in relation to product performance and characteristics:

• Temperature Range: "From 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point)."
• Physical Dimensions: "11.5 x 8 x 8 inches."
• Weight: "Under 10 pounds with the unit filled with water."
• Reservoir Capacity: "Maximum capacity of 2750ml."
• Leakage Current: "100 microamperes maximum."
• Flow Rate: "9 gph (34 lph) minimum, with the water circulating pad attached."

These are specifications, not "acceptance criteria" against which a clinical or performance study's results are measured and reported for the purpose of demonstrating efficacy or safety in the way an AI algorithm's performance would be.

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