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510(k) Data Aggregation
(90 days)
The Heat StimPlus, Model FDES115 is intended
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation.
It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.
The accessories include:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage.
The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The FDES115 is considered - OTC devices.
This device, "Heat StimPlus (Model FDES115)", is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) intended for temporary pain relief and muscle performance improvement, respectively. It does not rely on AI, machine learning, or complex algorithms that would require the typical acceptance criteria and study designs found in AI/ML medical device submissions. Therefore, the questions related to ground truth, number of experts, adjudication methods, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this device.
The provided document, an FDA 510(k) Premarket Notification summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device (HIVOX OTC Electrical Stimulator EM59-2, K203574) through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance:
Since the device is not an AI/ML device, the acceptance criteria are not in the form of diagnostic performance metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are adherence to established medical device standards and acceptable ranges for electrical stimulation parameters. The "reported device performance" is demonstrated through compliance with these standards and comparison of its technical specifications to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards/Limits) | Reported Device Performance (Compliance/Value) |
|---|---|---|
| Safety - Biocompatibility | Compliance with ISO 10993-1 for tissue-contacting devices (<24 hours) with tests for Cytotoxicity, Skin Sensitization, Skin Irritation. | Compliant: Biocompatibility evaluation conducted in accordance with ISO 10993-1. Tested for Cytotoxicity, Skin Sensitization, and Skin Irritation. |
| Safety - Electrical | Compliance with IEC 60601-1: 2012 (Medical electrical equipment - General requirements for basic safety and essential performance). | Compliant: Electrical safety testing conducted, complying with IEC 60601-1: 2012. |
| Safety - EMC | Compliance with IEC 60601-1-2: 2014 (Medical electrical equipment - Collateral Standard: Electromagnetic disturbances – Requirements and tests). | Compliant: Electromagnetic compatibility (EMC) testing conducted, complying with IEC 60601-1-2: 2014. |
| Bench Testing - General | Compliance with IEC 60601-1-11: 2015 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). | Compliant: Bench testing conducted, complying with IEC 60601-1-11: 2015. |
| Bench Testing - Specific | Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Edition 2.1 2016-04)). | Compliant: Bench testing conducted, complying with IEC 60601-2-10. |
| Software | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern). | Compliant: Software verification and validation testing conducted and documentation provided as recommended by FDA guidance. Software classified as "Moderate" level of concern. |
| Usability | Compliance with FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design." | Compliant: Usability testing conducted according to FDA Guidance 1757. |
| Output Electrical Parameters | Ranges specified for predicate device (e.g., Max Output Voltage, Current, Pulse Period, Frequency) | The proposed device, Heat StimPlus, has slightly different, but comparable, electrical output characteristics compared to the predicate device. For example: - Max Output Voltage (Vp, ±20%): @ 500Ω: 35V (Predicate: 50V), @ 2kΩ: 75V (Predicate: 90V), @ 10kΩ: 88V (Predicate: 125V). - Max Output Current (mAp, ±20%): @ 500Ω: 70mA (Predicate: 100mA), @ 2kΩ: 37.5mA (Predicate: 45mA), @ 10kΩ: 8.8mA (Predicate: 12.5mA). - Pulse Period (µs): 200 to 250 (Predicate: 50 to 450). - Frequency (Hz): 1 to 150 (Predicate: 1 to 150).The submission states that these differences do not adversely impact safety or effectiveness. |
| Max Temperature Setting | 43°C (for predicate device) | 43°C (for proposed device's max setting, specified as Level E3, with lower levels E1 up to 37°C and E2 up to 41°C). Predicate had Low and High settings up to 41°C and 43°C respectively. |
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 Sample Size: Not applicable. For non-clinical performance testing (biocompatibility, electrical safety, EMC, bench testing), the "sample size" typically refers to the number of devices or components tested. This information is not detailed in the summary but would be part of the full test reports.
- Data Provenance: The tests are reported as having been "conducted on the Heat StimPlus (Model: FDES115)." The manufacturer is Famidoc Technology Co., Ltd. in China. The data would be prospective, as it involves testing the manufactured device.
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):
Not applicable. As this is a physical medical device (TENS/EMS) undergoing engineering and safety testing, "ground truth" and expert reviews in the context of diagnostic interpretation are not relevant. Compliance with standards is typically assessed by engineers and testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and testing.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have a standalone algorithm for diagnostic or clinical decision support. Its performance is intrinsic to its hardware and pre-programmed stimulation settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for the reasons stated above. The "ground truth" for this device's performance is its physical and electrical adherence to engineering specifications and international safety standards.
8. The sample size for the training set:
Not applicable. This device 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 device is not an AI/ML device that requires a training set or associated ground truth.
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(351 days)
The Heat Sealing Sterilization Pouch Flat are intended to enclose another medical devices 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.
The Heat Sealing Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300x, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 90x559, 102x203, 127x381, 150x300, 150x300, 152x254, 152x559, 191x330, 200x300, 203x406, 300x400, 305x381, 305x457, 400x500, 457x559, 500x600.
Heat Sealing Sterilization Pouch Gusseted
The Heat Sealing Sterilization Pouch Gusseted are intended to enclose another medical devices 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.
The Heat Sealing Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 65x40x254.70 x 35 x 145.90 x 50 x 155.128 x 50 X 190.137x40x305, 150x50x380, 165x75x295. 200x33x340, 200x98x440,250x60x340,250x60x480,300x65x560.
Heat Sealing Sterilization Pouch Roll Flat
The Heat Sealing Sterilization Roll Flat are intended to be used to enclose another medical devices 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.
The Heat Sealing Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 50 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200.
Heat Sealing Sterilization Pouch Roll Gusseted
The Heat Sealing Sterilization Roll Gusseted are intended to enclose another medical devices 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.
The Heat Sealing Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 75 x 100,100 x 100,200 x 100,200 x 100,300 x 100,350 x 100,400 x 100,500 x 100,
The Heat Sealing Sterilization Pouch/Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark Green (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
The Sterilization Pouch/Roll is offered in the follow 4 types:
- Heat Sealing Sterilization Pouch Flat;
- Heat Sealing Sterilization Pouch Gusseted;
- Heat Sealing Sterilization Pouch Roll Flat;
- Heat Sealing Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Heat Sealing Sterilization Pouch Flat: These pouches are made from a medical grade paper and plastic (CPP/PET) film that is heat sealed on three sides, the forth side is left opened and will be heat-sealed when using. The Process Indicators Ink printed on the Pouch will exhibit a color change after the pouch is exposed to EtO gas or Steam.
Heat Sealing Sterilization Pouch Gusseted: These rolls are the same with the Heat Sealing Sterilization Pouch Flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Heat Sealing Sterilization Pouch Roll Flat: These rolls are made from a medical grade paper and plastic (CPP/PET) film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on it are the same with the sterilization pouches.
Heat Sealing Sterilization Pouch Roll Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The provided text is a 510(k) Summary for a medical device (Heat Sealing Sterilization Pouch/Roll). It details the device's technical characteristics and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance. Therefore, information regarding effect size of human readers with AI assistance (MRMC study) and standalone algorithm performance, as well as several aspects related to AI/ML device studies, cannot be extracted directly from this document.
Here's the breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Penetration testing as ASTM F1608 | Retention rate > 99.9% | Meet the acceptance criteria |
| Ethylene oxide residues testing as ISO 10993-7 | < 4 mg | Meet the acceptance criteria |
| Internal pressure testing as ASTM F1140/F1140M | > 30 kPa for bursting | Meet the acceptance criteria |
| Chemical Indicators performance testing as ISO 11140-1 | EO indicator: Initial Color: Pink -> Signal Color: Yellow; Steam indicator: Initial Color: Blue -> Signal Color: Dark Green | Meet the acceptance criteria |
| Tensile strength Testing as ASTM D882 | > 7.0 KN/m | Meet the acceptance criteria |
| Thickness testing as ASTM F2251 | (138 ± 3) µm | Meet the acceptance criteria |
| Air Permeability Coefficient Testing as ISO 5636-3 | > 8 µm/Pa.s | Meet the acceptance criteria |
| Tear Strength testing as ASTM D1922 | > 500 mN/15mm | Meet the acceptance criteria |
| Seal strength testing as ASTM F88 / F88M | > 4 N/15mm | Meet the acceptance criteria |
| Dye Penetration Testing as ASTM F1929 | No Dye Leakage | Meet the acceptance criteria |
| Dry Validation | 10 minutes (for prevacuum steam cycle) | Meet the acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed. It mentions "Non-clinical tests were conducted with the subject device," implying samples of the device were tested according to the specified ASTM and ISO standards.
- Provenance: These are non-clinical (laboratory) tests performed on samples of the manufactured device. The manufacturing company is Tianchang Jiarui Packaging Material Co., Ltd. in Anhui Province, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that does not involve expert interpretation or AI/ML ground truth establishment in this context. The acceptance criteria are based on standardized physical, chemical, and biological performance tests.
4. Adjudication method for the test set
Not applicable, as this involves objective laboratory tests with predefined pass/fail criteria, not subjective interpretation 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
No MRMC study was done. This document is for a physical medical device (sterilization pouches/rolls) and does not describe an AI/ML component or human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified international (ISO) and national (ASTM) standards for physical, chemical, and biological properties of sterilization barrier systems and chemical indicators. For instance, the ground truth for "Microorganism Penetration" is a retention rate >99.9% as measured by ASTM F1608.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's a physical product, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
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(106 days)
The Omron Heat Pain Pro Model PM311B is intended for:
The relief of pain associated with sore or aching, muscles of the lower back, arm, legs, shoulder, or foot due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
The Heat Pain Pro (PM311B) is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion batterv. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
Stimulation from PM311B is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls and indicators. Software controls waveform characteristics.
The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the PM311B. These are the identical accessories cleared under K160115 for the Model PM311.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The PM311B is identical to the PM311 cleared under 510(k) K160115, this submission is for expanded indications under product code NYN.
The PM311 and PM311B are considered - OTC devices.
The provided text is a 510(k) summary for the Omron Heat Pain Pro Model PM311B. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of AI/ML devices. Therefore, much of the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable or available in this document.
However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices to establish substantial equivalence.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of statistical metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" appear to be based on demonstrating that the proposed device, PM311B, is substantially equivalent to its predicate devices (PM311 and Avail) in terms of:
- Indications for Use: The PM311B's expanded indication for chronic, intractable pain and arthritis pain relief is identical to the Avail (K172079) predicate. Otherwise, its indications are identical to the PM311 (K160115).
- Design and Technology: Identical to the PM311, and equivalent to the Omron Avail.
- Performance and Specifications: Identical to the PM311, and equivalent to the Omron Avail. This is primarily demonstrated through the detailed "Output Specification Comparison" tables (pages 10-12) which show the technical parameters of the electrical stimulation.
- Patient Population: Adult (identical to predicates).
- Environment of Use: Clinics, hospital, and home environments (identical to predicates).
- Compliance with Voluntary Standards: Adherence to AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11 (identical to predicates).
Reported Device Performance (from "Output Specification Comparison" tables):
The PM311B is shown to have identical output specifications to its primary predicate, the Omron PM311 (K160115), across all tested parameters for its various modes (Tap, Knead, Rub, Arm, Lback, Leg, Foot, Joint, Shldr). These parameters include:
- Waveform (Biphasic, Rectangular shape)
- Maximum Output Voltage (@500Ω, @2kΩ, @10kΩ)
- Maximum Output Current (@500Ω, @2kΩ, @10kΩ)
- Duration of primary phase [usec]
- Pulse Duration [usec]
- Frequency [Hz]
- Net Charge (µC per pulse) (@500Ω) [µC]
- Maximum Phase Charge (@500Ω) [µC]
- Maximum Current Density (@500Ω) [mA/cm2] r.m.s.
- Maximum Average Current (average absolute value), mA
- Maximum Average Power Density (@500Ω) [W/cm²]
- Burst Mode parameters (N/A for this device)
- ON Time, OFF Time (N/A for this device)
The tables on pages 10 and 11 are identical, effectively stating that the PM311B's output is the PM311's output. The table on page 12 shows the specifications for the secondary predicate, Omron Avail (K172079), which has similar but not identical numerical values for some parameters, and also includes a "Microcurrent" mode not present in the proposed device. The "Discussion of Differences" column confirms that the proposed device, PM311B, is "Identical to predicate PM311 K160115" for almost all detailed features and electrical characteristics, except for the expanded indications for use, which are identical to the Avail.
2. Sample sized used for the test set and the data provenance
Not applicable. This device is an electrical nerve stimulator, not an AI/ML device relying on a "test set" in the context of diagnostic or prognostic model performance. The "testing" referred to is non-clinical engineering testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts is described as this is not an AI/ML diagnostic or prognostic system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device where adjudication of outputs would be 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
Not applicable. No MRMC study was conducted as this is not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device with an algorithm for standalone performance. The device's "standalone" performance is its electrical output, which was tested against engineering standards and compared to predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No "ground truth" of this nature is relevant for this device type within the context of the provided document. The "truth" lies in its adherence to electrical safety and performance standards and its equivalence to legally marketed 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 a training set or ground truth establishment in that context.
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(136 days)
The Omron Heat Pain Pro is intended for:
The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
The Heat Pain Pro is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat. TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
Stimulations from the device are intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.
The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the device.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Heat Pain Pro device:
The provided document is a 510(k) summary for the Omron Heat Pain Pro, a Transcutaneous Electrical Nerve Stimulator (TENS) device with heat for pain relief. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed here primarily relate to demonstrating equivalence in performance and safety to the predicate device, not necessarily a pre-defined clinical efficacy target like a reduction in pain scores.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by similarity to the predicate device (Omron PM3032, K141978) and compliance with specific electrical and medical device safety standards. The reported device performance is primarily a comparison of its electrical output parameters to those of the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (Heat Pain Pro) |
|---|---|
| Functional Equivalence | |
| Indications for Use equivalent to predicate. | The Omron Heat Pain Pro is intended for: The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. (Virtually identical to predicate.) |
| OTC device. | Yes |
| Design and Technology equivalent to predicate. | Equivalent design and features compared to the predicate (PM3032). Combines TENS and heat through the same basic technology as reference device (ezFit, K070299). |
| Patient Population equivalent to predicate. | Adult (Identical to predicate PM3032) |
| Environment of Use equivalent to predicate. | Clinics, hospital and home environments (Identical to predicate PM3032) |
| Electrical Performance Equivalence (compared to PM3032) | Parameters are generally very close or within comparable ranges to the PM3032 across various modes (TAP, KNEAD, RUB, ARM, LBACK, LEG, FOOT, JOINT, SHLDR). See detailed tables {10-11} for specific values, including: - Waveform: Biphasic, Rectangular (matches predicate) - Max Output Voltage, Max Output Current across various loads - Duration of primary phase, Pulse Duration, Frequency - Net Charge, Max Phase Charge, Max Current Density, Max Average Power Density - Burst Mode parameters (Pulses per burst, Bursts per second, Burst duration, Duty cycle) - ON Time, OFF Time |
| Material Equivalence | Patient contacting materials (PM-GELs) constructed of the same materials as the patient contacting portion of the Long Life Pads cleared in K120516. |
| Safety and Regulatory Compliance | |
| Compliance with AAMI / ANSI ES60601-1 | Complies (ES60601-1:2005 + A1: 2012) |
| Compliance with IEC 60601-1-2 (EMC) | Complies (IEC 60601-1-2: 2007) |
| Compliance with IEC 60601-1-11 (Home Healthcare) | Complies (IEC 60601-1-11: 2015) |
| Compliance with IEC 60601-2-10 (Nerve/Muscle Stimulators) | Complies (IEC 60601-2-10: 2012) |
| Compliance with 21 CFR 898 | Yes |
| Patient Leakage Current within limits. | Normal Condition: 1 uA (matches predicate). Single Fault Condition: 5.52 uA max (predicate: 8.9 uA max - acceptable). |
| Average DC current through electrodes (no pulse) at 0 uA. | 0 uA (matches predicate). |
| Automatic No-Load Trip feature. | Yes (matches predicate). |
| Automatic Shut Off feature. | Yes (matches predicate). |
| Low Battery and Voltage/Current Level Indications. | Yes (matches predicate). |
| Timer Range (30 mins vs 15 mins for predicate is a difference, but considered insignificant). | 30 minutes (Predicate: 15 minutes). The document implicitly accepts this difference as insignificant in terms of safety or effectiveness, likely due to patient safety features like automatic shut-off and user override. |
| Drop, Vibration, and Environmental Temperature/Humidity testing. | Performed. |
| Usability testing performed. | Performed (to address OTC use and differences vs. Rx reference device). |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a clinical test set from a clinical study. Instead, the "test set" for the non-clinical performance evaluation appears to be the device itself subjected to a series of engineering and electrical tests. The provenance is the manufacturer's internal testing.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated on the device itself against established electrical and safety standards.
- Data Provenance: The data is from non-clinical testing performed by the manufacturer, verifying the device's electrical output characteristics and compliance with standards. It is not patient data or human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no clinical ground truth established for a test set of patient data, as no clinical studies were performed. The "ground truth" for the non-clinical testing was defined by industry-recognized electrical and medical device safety standards and the performance parameters of the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was done, and no effect size for human readers with/without AI assistance is provided or applicable.
6. Standalone Performance Study
Yes, in a non-clinical sense. The device's performance was evaluated in a "standalone" fashion by subjecting it to various engineering and electrical tests as described in the "Non-Clinical Testing Summary" (e.g., testing controls, indicators, battery state, waveforms, compliance with standards like ES60601-1). This is performance of the algorithm/device itself in a lab setting, not a standalone clinical performance study on patients.
7. Type of Ground Truth Used
The "ground truth" for the substantial equivalence claim is:
- Predicate Device Performance: The electrical output and functional specifications of the legally marketed predicate device (Omron PM3032).
- Regulatory Standards: Compliance with recognized medical device safety and electrical performance standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10).
- Reference Device Performance: The basic technology and combined TENS+heat capabilities of the ezFit Digital Heating TENS (K070299) as a reference for integrating heat functionality.
8. Sample Size for the Training Set
Not applicable. There is no mention of an algorithm based on machine learning or AI that would require a training set. The device's operation is based on predefined electrical stimulation parameters and heating control.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
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(86 days)
-Heat scissors generator set
The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.
-Heat scissors handpiece (XRF-940-M)
The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.
The Heat scissors system has been designed to cut and coagulate tissue for general (open) abdominal surgery. This system consists of the Heat scissors generator, Heat scissors handpiece and foot switch. This system uses direct thermal energy and simultaneous pressure to cut and coagulate tissue. The thermal energy is generated at the Heat-generating section of the blade, on the Heat scissors handpiece. It is conveyed via a non-stick coating on the blade to the tissue.
This 510(k) summary for the Olympus Heat scissors generator set and Heat scissors handpiece does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.
The document states: "When compared to the predicate devices, 'Heat scissors system' does not incorporate any significant difference for safety and efficacy to the predicate devices. Therefore, clinical data is not necessary for its evaluation of its safety and efficacy." This explicitly indicates that no clinical study was performed to establish new acceptance criteria or demonstrate performance against such criteria.
Instead, the submission relies on substantial equivalence to predicate devices. This means that Olympus is claiming their Heat Scissors system is as safe and effective as existing legally marketed devices, rather than providing new performance metrics from a dedicated study.
Here's what can be extracted from the document regarding the device's design and testing, which are not the same as acceptance criteria and a study proving performance against them in the clinical sense:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in this document. The "acceptance criteria" here are implicitly linked to meeting the safety and efficacy profiles of the predicate devices.
- Reported Device Performance: Not reported in terms of specific clinical or measured performance metrics. The document instead states that the "Heat scissors system" has been designed, manufactured, and tested in compliance with voluntary safety standards IEC 60601-1 and IEC60601-1-2. It also notes that biocompatibility test reports show materials comply with ISO 10993-1. These are compliance statements, not performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical or comparative performance study with a test set is described. The tests mentioned (IEC standards, biocompatibility) are likely bench or material tests, not clinical performance tests on humans.
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)
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is 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
- Not applicable. This device is a surgical cutting and coagulation tool, not an AI-assisted diagnostic tool or system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth is described as being established for a performance study.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not an AI/ML algorithm that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is described.
In summary: The provided 510(k) summary for the Olympus Heat Scissors system does not describe a study to prove acceptance criteria in the way envisioned by the prompt. It focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and biocompatibility, negating the need for new clinical performance data.
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(50 days)
Heat Probe Unit HPU-20: The Olympus Heat Probe Unit HPU-20 has been designed for thermal cautery with the Olympus Heat Probes.
Heat Probe CD-110## /120##: The Olympus Heat Probe has been specifically designed to thermo-cauterize bleeding sites within the gastrointestinal tract under endoscopic observation.
The Heat Probe Unit HPU-20 and its associated accessories have been designed for thermal cautery. The Heat Probe Unit HPU-20 and its accessories consist of the heat probe unit, water container, water pump, foot switch and heat probe. Bleeding sites are thermo-cauterized by the heat that is conveyed via a non-stick coating from the tip of the heat probe to the tissue surface. The system is easy to use, poses no electrical hazard to the patient or physician, and is extremely effective as a means of nonsurgically treating severe bleeding in the gastrointestinal tract. The probes are available in two diameters (3.4 mm and 2.7 mm) and are designed to be used through the biopsy channel of any standard flexible endoscope. The system will deliver a selected amount of thermal energy, from five through thirty joules, directly to the bleeding site.
The provided text describes the Olympus Heat Probe Unit HPU-20 and its accessories, primarily for thermal cautery. However, the document does not contain information regarding the acceptance criteria, specific studies, or performance metrics in the format requested.
The document mainly focuses on:
- Device Identification: Manufacturer, contact, device name, common name, classification, and predicate device.
- Device Description: Functionality, components (heat probe unit, water container, water pump, foot switch, heat probe), and mechanism of action for thermal cautery in the GI tract.
- Intended Use: Thermal cautery with Olympus Heat Probes, specifically for thermo-cauterizing bleeding in the gastrointestinal tract under endoscopic observation.
- Technological Characteristics Comparison: Mentions changes in water pump, heat probe heater element, and materials compared to the predicate device.
- Non-clinical Tests: States compliance with voluntary safety standards (IEC 60601-1, IEC 60601-1-2, CISPR 11) and biocompatibility (ISO 10993-1).
- Substantial Equivalence Conclusion: Asserts no significant changes affecting safety or effectiveness compared to the predicate device.
- FDA Clearance Letter: Confirms substantial equivalence for the stated indications for use.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details from the provided text. The document is a 510(k) summary, which typically provides an overview for substantial equivalence determination but does not usually include detailed study protocols, results, or acceptance criteria in this level of detail.
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(60 days)
The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.
Warning: The facility should contact the manufacturer of the products to be placed inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags and bottles.
The Medical Solutions Heat Stack warming cabinet is designed to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, ec. prior to their use, using forced heated air.
This document is a letter from the FDA to a medical device manufacturer, confirming the substantial equivalence of a device. It does not contain any information about acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information.
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(90 days)
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