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The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

It appears there has been a misunderstanding. The provided FDA 510(k) clearance letter for the MICOR 700 System is for a Phacofragmentation System, which is a medical device used for surgery, specifically for cataract removal.

This document does NOT contain information about any AI/ML-based device, nor does it detail acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/ML performance.

Phacofragmentation systems are mechanical and electronic devices, and their "performance" criteria are typically related to:

• Power output and control: How effectively and safely they fragment the lens.
• Aspiration rate and vacuum control: How efficiently they remove fragmented lens material.
• Irrigation flow: Maintaining proper eye pressure during the procedure.
• Safety features: Overpressure limits, heat generation, sterile components.
• Biocompatibility: Materials used.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on this document. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML algorithms, not to a traditional surgical device like the MICOR 700 System.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.

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AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

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The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia.

Fractional Effects:
The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.

UltraClear Fractional Laser System is a transportable device. The system includes the 15" touch screen, on/off switch, foot peddle, an emergency stop button, remote interlock, and calibration port.
The device console houses most of the power consuming components, including the laser module, medical grade power supply, the scanner drivers, software, TEC cooling module, water pump, fans, software controls, and all other electrical control components.
The laser energy is delivered during treatment via the handpiece. A 635 nm visible red laser diode aiming beam is used to visualize the location of the beam during laser treatment.

The provided text describes a medical device, the UltraClear Fractional Laser System, and its 510(k) premarket notification to the FDA. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for device performance in a clinical context.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results for an AI algorithm is NOT present in this document.

The document discusses non-clinical performance studies to confirm functional specifications and biocompatibility, as well as software verification and validation. However, these are engineering and regulatory compliance tests, not clinical efficacy or performance studies with specific statistical acceptance criteria for clinical outcomes.

The document does not provide the information requested in terms of acceptance criteria for clinical performance or details of a study proving such criteria are met.

Here's a breakdown of what is and is not in the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines technical specifications for the device and compares them to predicate devices, but no clinical acceptance criteria or performance metrics against such criteria are mentioned.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. No clinical test set or data provenance is mentioned.
• 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 provided. This is relevant for clinical studies, which are not detailed here.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. This is relevant for clinical studies, which are not detailed here.
• 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 provided. This device is a laser system, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm in the context of diagnostic AI.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the context of clinical performance. The "ground truth" for the non-clinical tests would be the design specifications and recognized standards.
• 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI algorithm.

Summary of what the document does provide regarding device "performance":

The document states that "Acclaro Corporation conducted non-clinical performance studies to confirm the overall functional specification testing of the UltraClear Fractional Laser System against its design specifications and intended use."

The specific non-clinical tests mentioned are:

• Biocompatibility Testing: Conducted in accordance with ISO-10993-1 to demonstrate the patient-contacting material of the handpiece is safe for transient use (≤24 hours of contact).
• Electromagnetic Compatibility & Electrical Safety: Underwent testing with passing results according to recognized standards:
  • IEC 60825-1, 2007
  • IEC 60601-1, 2005+A1:2012
  • IEC 60601-1-2 Ed. 3, 2007-03
  • IEC 60601-2-22 Third Edition, 2007-05
• Software Verification and Validation Testing: Demonstrated the software is appropriate for release and that the system performed as intended, verifying energy outputs meet design specifications.

These are standard regulatory compliance tests for medical devices, confirming safety and adherence to technical specifications, but they do not describe clinical efficacy or performance against clinical acceptance criteria.

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Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

• Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, including: foraminoplasty
• Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs; Neck pain with radiation down the arm; Symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes; MRI. CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; Positive electromyography and/or nerve conduction studies; No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)
• Percutaneous Thoracic Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs; Thoracic and intercostal intractable pain; Paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myelography; MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium:YAG laser system designed to deliver pulsed infrared laser enerqy with a wavelength of 2.1 µm and 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.

The provided document is a 510(k) summary for the Trimedyne Holmium Laser Systems, which describes the safety and effectiveness of a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with explicit performance metrics and comprehensive study results akin to a clinical trial for a novel drug or a software-as-a-medical-device (SaMD).

Therefore, the requested information, particularly regarding acceptance criteria, study design for meeting those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this type of regulatory document for this device. The regulatory pathway here is a 510(k), which typically relies on comparisons to already marketed "predicate" devices and existing scientific literature/data.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• No explicit acceptance criteria with performance metrics are stated. The 510(k) process focuses on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, quantitative performance targets for a novel functionality.
• No specific device performance metrics are reported in this summary. The document describes the technological characteristics of the laser system (wavelength, pulsewidth, maximum output) but doesn't provide data on its performance against any pre-defined acceptance criteria for its intended use.

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

• Not applicable/Not provided. The document states that "Animal data and human clinical data from published literature were included." This indicates a reliance on existing, retrospective data rather than a newly conducted, primary clinical study with a defined test set. The exact sample sizes or provenance (country of origin, retrospective/prospective) of this published literature are not detailed in this summary.

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

• Not applicable/Not provided. Since a specific "test set" and a process for establishing its ground truth are not described (as reliance is on published literature), there is no information on experts for this purpose.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. No "test set" requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC study was done or reported. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key aspect. The Trimedyne Holmium Laser System is a surgical instrument.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The Trimedyne Holmium Laser System is a physical surgical laser device, not an algorithm or software. Its performance is intrinsically linked to its operation by a human user.

7. Type of Ground Truth Used:

• Not explicitly defined for a new study. The document refers to "Animal data and human clinical data from published literature." For a surgical device, "ground truth" in efficacy and safety would typically come from clinical outcomes, histological analysis of ablated/treated tissue, or direct observation of the surgical effect. However, the document does not elaborate on how ground truth was established within the cited literature for the purpose of this 510(k).

8. Sample Size for the Training Set:

• Not applicable/Not provided. As this is a hardware device relying on existing literature for safety and effectiveness, there is no "training set" in the context of machine learning or AI.

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

• Not applicable/Not provided. (See point 8).

Summary of Device Acceptance Criteria and Study:

Based on the provided K013974 510(k) summary, the device's "acceptance criteria" and "proof of meeting them" are framed within the context of the substantial equivalence pathway.

• Acceptance Criteria (Implied by 510(k)): The device must be deemed "substantially equivalent" to legally marketed predicate devices in terms of its intended use, technological characteristics, and demonstrated safety and effectiveness for its proposed applications.
• Study That Proves the Device Meets Acceptance Criteria:
  • The study consists of a comparative analysis against existing "standard surgical instruments, such as knives and forceps" (the predicate device) as well as relying on a review of "Animal data and human clinical data from published literature."
  • The submission outlines the technological characteristics of the Trimedyne Holmium Laser System (2.1 µm wavelength, 350 microseconds pulsewidth, 100 watts max power) and asserts that these are comparable or suitable for the stated indications.
  • The intended uses for incision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, specifically percutaneous cervical, lumbar, and thoracic disc decompression/discectomy, are supported by the literature review to be safe and effective.

In essence, the "study" is a compilation and synthesis of existing scientific evidence from published literature, used to argue that the Trimedyne Holmium Laser System performs similarly or adequately for its intended use compared to established methods and devices, thereby demonstrating "substantial equivalence." There are no explicit performance metrics, custom test sets, or dedicated expert reviews described for a novel performance goal within this 510(k) summary.

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NotFound

Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H; Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201

This FDA 510(k) letter for the Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager and Infrared Massager Set (models KM-213H and KM-201, respectively) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.

The letter is primarily a declaration of substantial equivalence to previously marketed predicate devices, which allows the manufacturer to market the new devices. It confirms that the devices are regulatory Class II and are subject to general controls.

Therefore, I cannot provide the detailed information requested in the prompt based on this document. The document primarily focuses on regulatory approval based on equivalence, not on specific performance metrics or studies.

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• RELIEVES MINOR MUSCLE ACHES AND PAINS
• DRY HEAT THERAPY FOR BODY SURFACES

Not Found

The provided document is a 510(k) premarket notification response from the FDA regarding two infrared massagers (Models KM-213H and KM-201) manufactured by Windmere Corporation. This type of document declares substantial equivalence to previously marketed devices and permits the devices to be marketed, subject to general controls.

Therefore, this document does not contain any information about acceptance criteria or supporting studies because it is a regulatory clearance letter, not a device performance report or clinical study summary.

Specifically:

• It does not list any acceptance criteria for device performance.
• It does not describe any study conducted to prove the devices meet such criteria.
• It does not include any of the detailed information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the determination is based on the devices being similar enough to existing devices, not on new performance studies against specific acceptance criteria for these particular models.

The "Enclosures" mentioned in the letter might contain the indications for use and potentially documentation from Windmere Corporation's 510(k) submission, which could include performance data if it was relevant for comparison to a predicate device. However, this specific letter does not provide that information.

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