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The Patient Warming System manufactured by Adroit Medical Systems is designed for the operating room (exclusive of the sterile surgical field), recovery room, anesthetic room, ICU, Medical/Surgical floors, in-hospital patient transport and emergency rooms. The Patient Warming System provides safe and controlled surface warming to assist adult patients to maintain normal body temperature.

Soft Air Patient Warming System: Blower Model SA4000 (110V) Mistral Air Patient Warming System: Blower Model MA0100 (220V) Soft Air Blankets (Non-sterile): Model 1187: Adult Full Body Model 1843: Adult Lower Body Model 1846: Adult Upper Body

This is a 510(k) clearance letter for a patient warming system (blower and blankets). This type of device is not an AI/ML powered device, and therefore the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, is not present in the provided text.

The letter addresses the substantial equivalence of the Soft-Air SA4000 and Mistral-Air MA0100 blanket models to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot provide the detailed information requested about acceptance criteria and AI/ML study specifics based on this document.

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SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc.

A SafePASS Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

SafePASS Sterilization Pouches are pouches made of previously 510(k) cleared sterilization wrap material. SafePASS Sterilization Pouches are provided to the end user in a partially folded condition, representing the first step of a patented folding system. After inserting the item or items to be sterilized, the pouch is closed by making the final two folds as described in the instructions for use. Once closed in this method and sterilized, the pouch allows convenient aseptic presentation of the enclosed device by following that section of the instructions for use.

SafePASS Sterilization Pouches are provided in both single and double thickness versions.

Safe PASS Sterilization Pouches are manufactured using the same material that is used to produce the SupraShield Sterilization Wrap product.

The difference is how the finished device is presented to the end user. For a SafePASS Sterilization Pouch, a sheet of material is folded over and sealed along two edges forming a pouch. This pouch then has a portion of the open end folded concentrically back over itself, thereby forming a cuff. From this point, the user inserts the item or items to be sterilized and closes the pouch by making the final two folds as instructed in the directions for use. The SupraShield Sterilization Wrap is provided to the end user as a flat sheet with the user folding it around the item to be sterilized as desired.

In some situations it is desired that two layers of sterilization wrap be used. For those situations SafePASS Sterilization Pouches will be available in both a single thickness and a double thickness version.

The provided documentation states that "This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data." This indicates that a study demonstrating that the device meets acceptance criteria was not part of this 510(k) submission.

Therefore, I cannot provide the requested information for the following points as they are dependent on a performance study that was not submitted:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The submission's basis for substantial equivalence is primarily on the device's intended use and its characteristics/specifications, which are stated to be similar or identical to a legally marketed predicate device (SupraShield hospital sterilization wrap, 510(k) number K921243). The key difference highlighted is the presentation of the device to the end-user (pre-folded pouch vs. flat sheet).

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The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations where a physician determines that heat therapy is necessary or desirable.

The HTP-1500 Localized Heat Therapy Pump is a small electronically controlled electric water heater containing a water reservoir, an electric resistance heater, a heat exchanger, an integral electric pump and associated tubing, hoses and fittings that allow it to be connected to a separate external pad. In use, the pump circulates water from the reservoir through the heat exchanger, associated tubing, hoses and fittings into and through the external pad. The operator, using a membrane switch keypad, selects the desired water temperature as observed and confirmed on a digital display. The electronic controller selectively turns on and off the electric resistance heater to heat the heat exchanger, thereby heating the water to the desired temperature. The actual water temperature is monitored and displayed on a digital display.

The provided document is a 510(k) summary for the HTP-1500 Localized Heat Therapy Pump, submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing new clinical study data with specific acceptance criteria, performance metrics, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, many of the requested details regarding acceptance criteria, study design for performance evaluation, sample sizes, expert qualifications, and ground truth establishment methods (which are standard for modern AI/ML device submissions) are not present in this document because they were not required for this type of submission at that time.

Here's an attempt to extract and interpret the information based on the prompt, acknowledging the limitations of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way it would for a performance study. Instead, it presents a "SPECIFICATION COMPARISON" table to demonstrate substantial equivalence to predicate devices (Seabrook SMS-2000 and SMS-1000). The implicit acceptance criteria are that the HTP-1500's specifications are comparable or superior to the predicate devices.

SPECIFICATION COMPARISON (Directly from document)

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

The document explicitly states: "This section is not required for this submission because substantial equivalence is based on intended use and device characteristics and specifications, and not on an assessment of performance data." (b, page 2).
Therefore, no separate "test set" or performance data (in the sense of a clinical or analytical study with a defined sample size and provenance) was provided or required for this 510(k) submission. The comparison is based on published specifications of existing devices.

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

Not applicable. As noted above, no performance evaluation requiring expert ground truth for a test set was conducted or submitted.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 is a submission for a hardware medical device (heat therapy pump), not an AI/ML device. Therefore, no MRMC study or assessment of AI assistance was performed.

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

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

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

Not applicable. No ground truth was established for "performance data" as no such data was submitted. The "ground truth" for the comparison is the published specifications of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires ground truth for a training set.

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Sterile Soft-Temp hot/cold therapy pads are intended for use in those situations where a physician determines that hot or cold therapy is necessary.

Sterile Soft-Temp hot/cold therapy pads are flat flexible pads with interconnecting passages for the circulation of hot or cold water. They are available in various sizes and shapes. The main portion of the pads consists of two inner layers of polyurethane film sandwiched between two outer layers of nonwoven cloth. These materials are held together by a pattern of welds created in a heat press. This pattern of welds produces the interconnecting passages that allow the hot or cold water to circulate from the input to the output. Two small diameter thermoplastic tubes are attached to the input and output areas of the pads, and fitted with plastic clamps for flow control and connectors. These connectors are used to attach the pads to longer tubes and adapters allowing connection to a source of hot or cold water. Thus a soft hot or cold flexible surface is available for thermal therapy.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Notes on Acceptance Criteria: The document primarily focuses on demonstrating that the sterilization process does not negatively impact the device's performance compared to its non-sterile equivalent. The specific quantitative acceptance criteria for burst strength, leak, and flow are not provided, only that there was "no substantial performance difference," which implies that the sterile pads met the same performance standards as the non-sterile ones. The "100% leak tested at 11psi-air" is a quality assurance parameter mentioned in the specifications data sheet, indicating a manufacturing quality control step that all units must pass.

Study Details

Based on the provided text, the study conducted was a non-clinical bench top study comparing the performance of sterile and non-sterile versions of the device.

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

   • Sample Size: Not explicitly stated. The text mentions "pads that were subjected to the gamma sterilization process and on pads that were not subjected to the gamma sterilization process," implying a comparison group. However, the exact number of pads tested is not provided.
   • Data Provenance: Not explicitly stated, but it would be considered internal company testing since it was conducted by Adroit Medical Systems, Inc. The nature of the tests (burst strength, leak, flow) suggests these are bench-top engineering tests, not clinical data from patients. Therefore, country of origin related to patient data is not applicable. The study is prospective in the sense that the sterile pads were deliberately subjected to gamma radiation for the purpose of this comparison.

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

   • Not Applicable. This was a physical performance study (burst strength, leak, flow) on the device itself, not a study requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" would be objective measurements of physical properties.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic studies. This study involved objective physical measurements.

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:

   • No. This was not an MRMC comparative effectiveness study involving human readers or AI. It was a physical performance study of a medical device.

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

   • Not Applicable. This device is a hot/cold therapy pad, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" for this study was objective physical measurements of device performance characteristics (burst strength, leak integrity, and flow rate). The performance of the non-sterile pads served as the baseline or existing "truth" against which the sterile pads were compared.

7. The sample size for the training set:

   • Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithms.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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