(61 days)
The INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device is the result of integrating the cleared fluoroscopy imaging device - 3Dscope and lithotripter. INTEGRA also contains the necessary interfaces for ultrasonic imaging devices.
INTEGRA includes the following features:
- EM Shockwave generator with parabolic reflector for focusing mechanism A
- High Level of integration: the shock wave generator is fully integrated with A the fluoroscopic system and stationary patient table.
- In lieu of the patient table movement the reflector is moved in three A directions
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In-line X-Ray localization system which is executed with lateral movement
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Off-line movable Ultrasound transducer
The provided text describes the Integra Extracorporeal Shock Wave Lithotripter (ESWL) and its FDA 510(k) submission. However, it does not contain specific acceptance criteria or reported device performance data in a quantitative format related to clinical outcomes or device efficacy for stone fragmentation.
The document primarily focuses on:
- Device Description and Intended Use: Fragmenting urinary stones in the kidney and upper ureter.
- Predicate Devices: Storz Modulith SL-20/(SLX), Storz Modulith Lithotripter Model SLK, Direx Tripter X - 1 Compact Duet, Direx 3Dscope.
- Performance Testing (Engineering Standards): Compliance with various IEC, FDA CDRH, ANSI/AAMI/ISO, and CISPR standards related to electrical safety, EMC, and radiation control.These are technical safety and performance standards for the device itself, not clinical efficacy metrics.
- Clinical Tests: It states that a "Confirmatory study was conducted according to 'Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000, Chapter 8 subchapter D: (Clinical Performance Testing, confirmatory clinical study)'." However, the results or specific acceptance criteria from this clinical study are not provided in this document excerpt.
- Substantial Equivalence Argument: Comparing Integra's features (shockwave generation, focusing, X-ray and Ultrasound localization) to its predicate devices.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from the provided text. The text indicates that a clinical study was performed, but the details of that study, including the acceptance criteria and its results, are missing.
Here's a breakdown of what can be extracted or inferred, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text for clinical efficacy. | Not specified in the provided text for clinical efficacy. The document states that a "Confirmatory study was conducted" following FDA guidance, but the outcomes or specific metrics (e.g., stone-free rate, fragmentation success rate) are not detailed. |
| Compliance with various safety and performance standards (e.g., IEC 60601-1, FDA CDRH 21CFR 1020.30, etc.) | The device was tested according to these standards, implying compliance, but specific results (e.g., measured EMI levels, radiation leakage) are not listed. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: The document states a "Confirmatory study was conducted," implying clinical data, but the country of origin, retrospective/prospective nature, and specific details are not available in this excerpt.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not mentioned. This device is an ESWL lithotripter, a therapeutic device, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study related to human readers improving with AI assistance would not be applicable or expected for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a hardware therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "Confirmatory study," it would likely involve outcomes data directly related to stone fragmentation and removal (e.g., post-procedure imaging for stone-free status or residual stone size). However, this is inferred, not explicitly stated, and specific details are not available.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable, as this is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable, as this is not an AI/ML algorithm requiring a training set.
Summary of Missing Information: The provided 510(k) summary explicitly refers to a "Confirmatory clinical study" but does not include the details of its methodology (sample size, ground truth establishment, expert involvement, etc.) or its results (acceptance criteria, device performance). The document primarily addresses engineering performance standards and argues for substantial equivalence based on device features rather than clinical efficacy data within this excerpt.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)