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The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Omnispec™ ED1000 is a portable, self-contained Shock Wave Therapy unit. It employs an electro-hydraulic method of creating shock waves. With this technique, an electrode, located within a water-containing stainless-steel reflector chamber called Shock Wave Applicator (SWA), ignites an electrical discharge, evaporating a small portion of the water and creating a shock wave reflecting outward off the reflector through a flexible membrane. The result is a shock (pressure) wave that passes through a conducting medium (patient). The shock wave is transmitted through the skin surface of the patient to the treatment site. The device provides focused pressure pulses where the second focus (F2) occurs within the membrane of the applicator.

The provided document is a 510(k) summary for the Medispec Omnispec ED1000, a therapeutic massager. It details the device's characteristics, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML model's performance. The performance testing section specifically refers to hardware and software validation, biocompatibility, safety standards, and physical parameters of the shockwave output. It emphasizes that this device is a physical therapeutic massager, not an AI/ML powered device.

Therefore, I cannot provide the requested information regarding AI/ML model acceptance criteria, study design, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as these elements are not present in the provided document for this specific device.

The "Performance Testing" section states:
"Verification and validation testing were performed and demonstrated that Omnispec™ ED1000 met the design specifications and it was safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed successfully."

And the "Clinical Testing" section states:
"Not applicable"

This indicates that the device's performance was evaluated through non-clinical, engineering, and bench testing, rather than studies involving AI/ML performance metrics.

In summary, none of the specific requests related to AI/ML model acceptance criteria and validation studies can be fulfilled from the provided text because the device described is not an AI/ML device.

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The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.

Medispec Ltd.'s Econolith™ EM1000 system is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.

The EM1000 device includes a shock wave generator which is based on an Electromagnetic shock wave head and is to be used in conjunction with a multi axes Motorized Treatment Table, a C-Arm X-ray/fluoroscope imaging unit, an ECG monitor, and an anesthesia apparatus, which may be supplied by the user. The device also contains the necessary interface for optional Ultrasonic imaging devices. The EM1000 includes the following components for patient handling, positioning and shock wave generation:

• Shockwave Generator
• Electromagnetic Shock wave head,
• High-Voltage System.
• Water System,
• Treatment Table Control,
• ECG System.
• Control and Timing Circuitry, and
• Front Panel Controls

The provided text describes a 510(k) premarket notification for the Medispec Econolith™ EM1000, an Extracorporeal Shock Wave Lithotripter (ESWL). This document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI diagnostic might.

No specific acceptance criteria values or a detailed study proving the device meets them are provided. The submission relies on establishing substantial equivalence to existing devices and compliance with FDA guidance and performance standards.

Here's an analysis based on the provided text, addressing the requested points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "All specifications are in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards." However, it does not list these specific criteria or the EM1000's performance against them.

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission for a medical device (lithotripter), not an AI diagnostic algorithm. There is no mention of a "test set" in the context of evaluating an algorithm's performance on data. The evaluation for this device would typically involve bench testing, engineering specifications, and a comparison to predicate devices, not data-driven performance metrics on a specific dataset.

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

Not applicable. As this is not an AI diagnostic, there is no "ground truth" established by experts on a test set in the sense of image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging systems or AI software, often comparing human reader performance with and without AI assistance. This document describes a physical medical device (lithotripter) and does not involve human readers interpreting data.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical lithotripter system, not a standalone algorithm. Its operation inherently involves a human operator (e.g., a urologist) and other medical equipment.

7. Type of Ground Truth Used

Not applicable in the context of an AI diagnostic. For this medical device, the "ground truth" would relate to its engineering specifications, safety, and effectiveness in fragmenting stones, which would be evaluated through pre-clinical testing (e.g., in vitro stone fragmentation studies, animal studies) and clinical experience with predicate devices, rather than a diagnostic 'ground truth'. The document confirms the device's "Intended Use" as "non-invasive fragmentation of upper urinary tract stones."

8. Sample Size for the Training Set

Not applicable. As this is not an AI diagnostic, there is no "training set."

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

Not applicable.

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The Econolith™ E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.

Medispec Ltd.'s Econolith™ E3000 uses shock waves generated outside the patient's body to fragment urinary calculi within either the kidney or upper ureter. The device consists of an electrony draulic shock wave generator, control panel, and motorized patient table. Although the device does not provide imaging or monitoring functions, it does contain dedicated interfaces for the requisite fluoroscopic imaging and ECG monitoring.

The shock wave generator is a self-contained unit which includes an underwater electrode, a control system, and a high voltage power supply system.

The treatment table is specifically designed for use with the Econolith™ Lithotripter. The table can position the patient in multi-dimensions and also provides access to the patient's lumbar region through removable inserts.

The provided document is a 510(k) summary for the Medispec Ltd. Econolith™ E3000, an Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the format requested.

Therefore, the document does not contain the detailed clinical study information required to fill out a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or adjudication methods for a standalone study designed to prove the device meets specific performance metrics.

The document primarily states that the device's "Technological Characteristics" are "in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards." This implies that the device was evaluated against existing standards and guidance, but the specifics of that evaluation (e.g., breakdown of performance metrics, sample sizes, and ground truth establishment) are not provided in this summary.

Based on the provided text, I cannot complete the requested information for a clinical study proving the device meets specific acceptance criteria.

The document's purpose is to show substantial equivalence, not to detail the results of a primary clinical study establishing performance against new acceptance criteria.

Information that can be extracted from the provided text, but does not directly answer the requested questions:

• Intended Use/Indications for Use: Non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
• Predicate Device: HealthTronic's Lithotron Lithotripsy System (P970019).
• Basis for Substantial Equivalence: Similar intended use, principle of operations, ancillary equipment, and technological specifications.
• Regulatory Guidance: FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000, and all applicable performance standards.

Conclusion: The provided 510(k) summary does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving a device meets them through empirical data. It serves as a regulatory document demonstrating equivalence to an already approved device.

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The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.

The LITHOSPECTM is a direct contact intracorporeal lithotripter which fragments bladder, ureteral and renal calculi by utilizing direct endoscopic techniques. The electromechanical technique ensures the delivery of high impact mechanical fragmentation power to the stone while eliminating the possibility of thermal injury. Four reusable Probes, having diameters: 0.8 mm, 1.6 mm, and 2.0 mm, are provided with the system. The LITHOSPEC™ is operated using standard endoscopic equipment.

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of typical AI/ML medical device evaluations (e.g., sensitivity, specificity, AUC, human reader studies).

Instead, this document is a 510(k) summary for a mechanical intracorporeal lithotripter (LITHOSPEC™), a physical medical device for crushing kidney stones. The "performance" described here refers to its mechanical capabilities and safety compliance, not AI algorithm performance.

Therefore, I cannot fulfill the request as the type of information requested (acceptance criteria and study design for AI/ML performance) is not present in the provided context for this particular device.

Here's why and what can be inferred:

• Type of Device: The LITHOSPEC™ is a physical surgical tool, an "Intracorporeal Lithotripter," not an AI/ML diagnostic or predictive algorithm.
• Performance Standards: The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Instead, it complies with general electrical safety and EMC (Electromagnetic Compatibility) standards like IEC 601.1.2, IEC 801.1-801.5, EN 55011, and EN 50081-1. This is typical for electromechanical devices.
• Substantial Equivalence: The primary "proof" of its safety and effectiveness for a 510(k) clearance is its "substantial equivalence" to predicate devices (EMS SWISS LITHOCLAST LITHOTRIPTER cleared under K951531 and K963285) in terms of intended use, technological characteristics, performance, and labeling. This means it is presumed to be as safe and effective as devices already on the market without needing extensive new clinical trials for performance metrics like sensitivity/specificity.

To directly answer your specific points based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable/Not provided in the context of AI/ML performance. Performance mentioned relates to compliance with electrical safety and EMC standards.
2. Sample sized used for the test set and the data provenance: Not applicable. No "test set" in the AI/ML sense is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: Not applicable in the AI/ML diagnostic sense. The "ground truth" for this device would be its mechanical ability to fragment stones safely, likely evaluated through bench testing, animal studies, and/or clinical experience demonstrating equivalent function to predicate devices, rather than a diagnostic 'truth'.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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