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The Squid Active Cold Compression device and Cold Pack for the temporary relief of minor muscle aches and pains.

The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.

The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.

The device is manufactured with the following components:

• 1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
• 2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
• 3. Reusable thermogel cold pack

The provided text is a 510(k) Summary for the Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC Use. The primary purpose of this 510(k) is to reclassify an existing prescription-use device (K123829) for over-the-counter (OTC) use. Therefore, the "study that proves the device meets the acceptance criteria" largely refers back to the predicate device's clearance information and a specific usability study for the OTC application.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is primarily for reclassifying an existing device to OTC use, the "acceptance criteria" are implied by the substantial equivalence to the predicate device and the specific performance testing performed for the original clearance (K123829), plus a usability study for the OTC shift.

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

• Test Set (for Usability Study): "representative users for OTC use." The specific sample size is not disclosed in this summary.
• Data Provenance: Not explicitly stated, but the submission is to the US FDA, implying an expectation of US-centric or internationally recognized standards. The usability study would have been prospective to evaluate OTC use. The original K123829 performance data would have been generated during the device's development/validation.

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)

• There is no mention of "experts" to establish ground truth for a test set in the context of medical image analysis or diagnosis. For this device (cold compression massager), the evaluation is against engineering specifications and user comprehension/safety.
• For the usability study, "representative users" were involved, not "experts" establishing ground truth in a diagnostic sense.

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

• Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert interpretations of data (e.g., medical images). The usability study would likely have involved user observation and task completion rates.

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

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices (e.g., AI-powered image analysis) where the performance of human readers (e.g., radiologists) is compared with and without AI intervention. The Portable Therapeutix Squid is a physical therapy device, not a diagnostic tool where "human readers" are involved in interpretation.

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

• This is not applicable to the Portable Therapeutix Squid device. There is no "algorithm" in the sense of AI or image processing being evaluated in a standalone mode. The device's function is mechanical compression and cold therapy. Its "standalone performance" refers to its ability to meet engineering specifications (e.g., pressure output, safety). These were part of the bench testing for K123829.

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

• For K123829 (Predicate device performance): The ground truth was based on engineering specifications, safety standards compliance (e.g., electrical safety), and the successful execution of various bench tests (e.g., pressure verification, leak tests, shelf life).
• For K133483 (OTC Usability): Ground truth was established by demonstrating that representative lay users could safely and effectively operate the device and understand its instructions for use without professional guidance. This typically involves observing task completion, questionnaire responses, and identifying critical use errors.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning device that requires a "training set" in that context. The "training" for the device's function would be its design, manufacturing, and calibration processes.

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

• Not applicable, as there is no "training set" in the machine learning sense for this device.

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The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.

The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.

The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

The Squid Active Cold Compression device and Cold Pack combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a pre-programmed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.

The device is manufactured with the following components:

1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
3. Reusable thermogel cold pack

Here's a breakdown of the acceptance criteria and the study information for the Portable Therapeutix Squid Active Cold Compression device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" conducted to demonstrate the device meets acceptance criteria is a substantial equivalence comparison to predicate devices, as documented in the provided 510(k) summary. This is a common regulatory pathway for medical devices.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable or not explicitly stated in the provided text. The submission relies on a comparison to predicate devices based on their established safety and effectiveness profiles, rather than a separate clinical "test set" for this specific device to demonstrate its intended use. Performance data is primarily from bench and EMC testing, not clinical trials with "test sets" of patients.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance for the comparison itself is from existing 510(k) submissions of predicate devices (K030437 and K112479) and internal bench/EMC testing for the subject device. There is no mention of country of origin for such data or whether it's retrospective or prospective for a clinical trial.

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

• Number of Experts & Qualifications: Not applicable. This type of information is typically related to diagnostic devices or clinical trials where expert consensus is needed to establish ground truth for a test set. For this device, regulatory experts at Portable Therapeutix (via MEDIcept, Inc.) performed the substantial equivalence comparison and FDA reviewers (Victor Krauthamer, Ph.D., Acting Director, Division of Neurological and Physical Medicine Devices) made the final regulatory determination.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical "test set" requiring adjudication in the context of this 510(k) summary.

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

• MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a physical therapy device like the Squid Active Cold Compression device, which does not involve "readers" or "AI assistance" in a diagnostic context.

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

• Standalone Performance: Not applicable. This device is a physical therapy device, not an algorithm. Its operation inherently involves human interaction (applying the device, selecting settings).

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices as previously cleared by the FDA. The submission argues that the subject device is substantially equivalent to these predicates, meaning it shares the same fundamental scientific technology, intended use, and does not raise different questions of safety or effectiveness. For aspects like electrical safety, the ground truth is adherence to internationally recognized standards (IEC 60601-1).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set" in the conventional sense. Device development and testing (bench, EMC) would involve engineering samples and prototypes, but not a "training set" for an algorithm.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an algorithm.

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