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The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

As an NMES device, indications are for the following conditions:

• Relaxation of muscle spasms
• Retardation or prevention of disuse atrophy
• Increasing local blood circulation
• Re-educating muscles
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain

The CyMedica Orthopedics QB1 System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The QB1 system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The OB1 NMES and TENS systems are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

In NMES mode, the QB1 system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The OB1 NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.

In NMES mode, the OB1 system consists of a Conductive garment with an incorporated NMES pod, User Interface device with a battery charger, NMES electrodes, and electrode gel.

The QB1 device also offers a TENS program for pain management. The QB1 TENS system consists of a TENS pod. User Interface device with a battery charger. TENS electrodes, and electrode gel.

The QB1 User Interface is programmed with an embedded software to manage the treatment programs and communicate with the User Interface touchscreen, NMES conductive garment, and TENS pod. The User Interface allows the user to select a treatment from the available treatment programs stored in the memory component of the NMES conductive garment and TENS pod. The User Interface utilizes a touchscreen and tactile buttons for user control. The User Interface device is powered by an internal rechargeable 3.7 V Lithium Ion battery that, when fully charged, can deliver at least three-20 minute treatments before requiring a recharge. The QB1 USB charger can fully recharge the battery in approximately five hours.

The QB1 system accessories include:

• . OB1 electrodes for NMES application
• OB1 electrodes for TENS application
• QB1 electrode gel ●

The provided text describes a 510(k) premarket notification for the CyMedica Orthopedics QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS). This document contains information about the device's indications for use, technological characteristics, and performance data, primarily focusing on non-clinical testing to demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria for a study demonstrating device performance as requested in the prompt, nor does it specify a study with acceptance criteria being met.

Therefore, many of the requested details cannot be extracted directly from this document. The document describes several non-clinical tests conducted to establish safety, effectiveness, and substantial equivalence, but not a study designed to meet specific performance acceptance criteria in the way envisioned by the prompt.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

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

• Cannot be provided. The document lists various standards the device was tested against (e.g., IEC 60601-1, IEC 60601-2-10 for electrical safety, ISO 10993 for biocompatibility, IEC 62366 for usability), and states that the device "meets all standard requirements" or "complies" with these standards. It also mentions "low current and voltage values" and "maximum current densities of QB1 are lower than Kneehab XP and MediStim XP." However, it does not explicitly define specific "acceptance criteria" (e.g., a minimum sensitivity or specificity_ and then report the device's performance against those criteria. The performance reported is primarily compliance with established safety and efficacy standards and lower electrical outputs compared to predicates.

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

• Cannot be provided for performance metrics related to acceptance criteria. The document states that a "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." It doesn't specify the sample size for this usability study. For other tests (electrical safety, EMC, software verification, biocompatibility, risk management), these are typically bench tests or analyses, not studies involving human subjects with a "test set" in the sense of clinical performance data.

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/Cannot be provided. This question is typically relevant for studies evaluating diagnostic or prognostic algorithms where expert consensus establishes ground truth (e.g., image interpretation). This document describes a medical device (muscle stimulator) undergoing non-clinical testing for safety and functional equivalence, not a diagnostic algorithm.

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

• Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving the interpretation of data, where multiple experts might disagree and an adjudication process is needed. The testing described here does not involve such a process.

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. This device is a muscle stimulator, not an AI-powered diagnostic or interpretive tool that assists human "readers" (like radiologists). Therefore, an MRMC comparative effectiveness study of the type described would not be relevant. The document's effectiveness claims are based on meeting safety standards and having comparable or lower electrical output parameters than predicate devices.

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

• Not applicable/No. This device is an electrotherapy device with hardware and embedded software. Its "performance" is its ability to deliver specified electrical stimulation safely and effectively. The tests are effectively "standalone algorithm" tests in that they evaluate the device itself (including its software), but not in the diagnostic performance sense often implied by this question. The device's operation inherently involves user interaction (e.g., selecting programs, adjusting intensity), so it's not strictly an "algorithm-only" performance without any human involvement for its intended use, but the testing focuses on the device's adherence to technical standards.

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

• Not applicable/Cannot be provided in the context of diagnostic "ground truth." For this device, "ground truth" would relate to the physical and electrical parameters it's designed to produce. Compliance with standards (e.g., IEC 60601-2-10 for nerve and muscle stimulators) and comparison to predicate device characteristics serve as the reference for its functional performance and safety.

8. The sample size for the training set

• Not applicable/No training set. This is a hardware medical device with embedded software, not a machine learning model that requires a distinct "training set." The software validation mentioned is about verifying requirements, not training a model.

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

• Not applicable/No training set. As above, there is no training set for this type of device.

Summary of available information regarding performance and testing (not explicitly "acceptance criteria met by a study"):

Device: QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS)

Performance Data and Basis for Substantial Equivalence:

The submission relies on non-clinical testing data to demonstrate substantial equivalence, focusing on safety and function.

• Safety: The QB1 system was tested for:

  • Electrical safety: Compliance with IEC 60601-1, IEC 60601-2-10 ("Particular requirements for the basic safety and essential performance of nerve and muscle stimulator"), and IEC 60601-1-11 ("Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"). The system "compiles with" these standards.
  • Electromagnetic compatibility (EMC): Compliance with IEC 60601-1-2. The system "compiles with" this standard.
  • Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
  • Risk Management: Compliance with ISO 14971.
  • Usability: Compliance with IEC 60601-1-6 and IEC 62366. A "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." The "results of the study support the instructions for successfully using the device as intended" and "substantiates the acceptability of the risks identified."
  • Software Verification & Validation Testing: Validated in accordance with FDA Guidance (May 11, 2005). The tests "demonstrated that the software version meets its design requirements."

• Effectiveness/Functional Equivalence:

  • The document implies effectiveness by demonstrating that the QB1 system's electrical output parameters (waveform, shape, voltage, current, duration, frequency, etc.) are comparable to or "lower" than predicate devices (Kneehab XP, K110350, and MediStim XP, K082011), ensuring it "poses no new safety risks" and "is substantially equivalent to the predicate."
  • Specifically, in "OB1 Design Verification & Validation, QB-0030-034, Section 018", it is stated that "the maximum current densities of OB1 are lower than Kneehab XP and MediStim XP" despite differences in electrode size. It also notes that "OB1 waveforms are at lower voltage and current and therefore power levels than the Kneehab XP and MediStim XP."

This information focuses on technical compliance and comparative electrical characteristics rather than specific performance metrics against pre-defined acceptance criteria in a clinical study.

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