Search Results

The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.

The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.

The provided text describes the 510(k) premarket notification for the Peralta Stone Removal Catheter. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical testing. However, it explicitly states "No clinical data were provided in order to demonstrate substantial equivalence."

Therefore, based on the provided document, a study proving the device meets acceptance criteria related to clinical performance or human reader studies does not exist in this submission. The acceptance criteria and "study that proves the device meets the acceptance criteria" would primarily refer to the non-clinical testing performed.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission primarily relying on non-clinical testing and substantial equivalence, the "acceptance criteria" are derived from the performance standards and tests outlined. The document does not provide specific numerical acceptance criteria for each test, but rather states that the device "conforms to the performance specifications."

2. Sample size used for the test set and the data provenance:

• Biocompatibility: Not specified, but standard ISO testing involves specific sample sizes for tests like cytotoxicity and sensitization.
• Dimensional, Functional, Usability, Mechanical Testing: Not specified, but generally a representative sample of manufactured devices would be tested.
• Ex Vivo Testing: "Ex vivo testing in porcine ureters was performed." Sample size (number of ureters or experimental runs) is not specified.
• Animal Testing (In Vivo): "In vivo testing on four ureters in a porcine model." This implies a sample size of four ureters.
• Data Provenance: The studies were sponsored by Calcula Technologies, Inc., and performed as part of their 510(k) submission. The location of the studies is not explicitly stated in the document, but it is implied to be part of their regulatory compliance process for the US market. The studies are prospective in nature, as they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable in the traditional sense for this submission. For a medical device 510(k) that relies on non-clinical testing for substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes or images in the same way it would be for an AI/CADe device. The ground truth for the non-clinical tests is established by direct measurement, physical performance, and biological responses according to established protocols.
• The "experts" involved would be the engineers, scientists, and technicians conducting the performance, mechanical, and biocompatibility tests, following validated methods. Their qualifications are not specified but are implied to meet industry standards for such testing.

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

• None in the context of expert adjudication of clinical outcomes or images. The "adjudication" for non-clinical tests would involve review and approval of the test protocols and results by internal quality and regulatory personnel.

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, an MRMC study was NOT done. This type of study is relevant for AI-powered diagnostic or CADe devices where human readers' performance is augmented by AI. The Peralta Stone Removal Catheter is a physical medical device, not an AI/software device designed to assist human interpretation.

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

• No. This question is not applicable. The device is a physical catheter, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is based on:
  • Direct measurements (for dimensional verification).
  • Defined physical parameters and failure points (for functional and mechanical testing).
  • Biological responses (for biocompatibility, e.g., cell viability, irritation response).
  • Observation of performance in simulated environments (ex vivo and in vivo animal models demonstrating the ability to grasp, manipulate, and remove stones, and dilate ureters).
• In the animal study, the ground truth was the pre-placed urinary stones (3mm and 4.3mm) and the observed ability of the device to remove them.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

Ask a specific question about this device

The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.

I apologize, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Accordion Piccolo Stone Management Device." It describes the device, its intended use, predicates, and some benchtop performance tests.

However, it does not include any information about:

• Acceptance criteria for performance (beyond general safety and effectiveness claims compared to a predicate).
• Details of a clinical study or a test set with specific performance metrics.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes).
• Training set details or how ground truth for training was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering changes and benchtop mechanical testing, rather than a clinical performance study involving AI or diagnostic accuracy that would require the details you're asking for.

Ask a specific question about this device

The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.

The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.

The provided text is a 510(k) summary for a medical device (PercSys Accordion® Stone Management Device) and details its intended use, description, and substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria, device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The document states: "Bench top and clinical data from the literature were submitted in support of the proposed performance claims for this 510(k) submission, as well as in support of documenting that the changes in device materials and sterilization method has not affected design specifications." and "The bench top and clinical data show the Accordion device is as safe and as effective as the predicate devices and support the proposed advertising claims."

However, it does not provide the details of this data, making it impossible to answer the specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.

Ask a specific question about this device

The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.

The provided text mentions "Performance Data: Not required" for the Coaxial Accordion Stone Management Device. This implies that no specific performance study with acceptance criteria was conducted or necessary for its 510(k) clearance based on substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given document. The device received clearance based on its "same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices."

Ask a specific question about this device

The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.

The provided text is for a 510(k) premarket notification for a medical device called the "ACCORDION Urological Occluding Guidewire." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials for performance data.

Therefore, the document explicitly states:

"Performance Data Not required."

This means there is no acceptance criteria or study data provided in this document to prove the device meets acceptance criteria in the way you are asking (e.g., through clinical performance metrics, sample sizes, expert ground truth, or comparative effectiveness studies).

The primary purpose of this 510(k) submission is to assert that the ACCORDION Urological Occluding Guidewire is substantially equivalent to existing, legally marketed predicate devices. This equivalence is based on:

• Same intended use: "The ACCORDION Urological Occluding Guidewire is intended to be used The ACCORDION Orological Other a two-part guidewire with a removable handle." (This sentence appears to have a transcription error, but the "Intended Use" section on the first page clarifies: "The ACCORDION Urological Occluding Guidewire is intended to be used endoscopically to entrap instrumention within the ureteral tract" and the "Indications for Use Statement" on page 4 provides a more detailed description).
• Same indications for use: "The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract."
• Similar technological characteristics: "The ACCORDION Urological Occluding Guidewire has the same intended The ACCORDION Orologiour Orologiour Oroclading Coperation and Very similar use, Indications for doe, ans as the predicate devices. Thus, the technological charactenstics as the prodicate about - Includes devices." (Again, some transcription issues in the text, but the intent is clear).

In the context of this 510(k) submission, the "acceptance criteria" for the device's market clearance largely revolve around demonstrating this substantial equivalence to predicate devices, rather than meeting specific performance thresholds from a de novo study.

Ask a specific question about this device

Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.

SterilMed's reprocessed stone retrieval baskets consist of a handle, shaft/sleeve, and a wire basket which serves as the stone capturing mechanism. They come in diameters ranging from 1.9 French to 8.0 French, and lengths ranging from 70 cm to 220 cm. The baskets are available in 3 to 8 wire configurations and flat or helical wire designs.

The provided document describes the 510(k) premarket notification for SterilMed's Reprocessed Stone Retrieval Baskets. This is a medical device submission for reprocessing existing devices, not a new AI/ML-driven device. Therefore, many of the requested categories in the prompt, such as acceptance criteria based on performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable here.

The "device" in this context is the reprocessed version of existing stone retrieval baskets, and the study focuses on validating the reprocessing methods to ensure the reprocessed devices are substantially equivalent to new, predicate devices.

Here's the information that can be extracted from the provided text, framed within the context of a medical device submission for reprocessing:

Acceptance Criteria and Study for SterilMed's Reprocessed Stone Retrieval Baskets

1. Table of Acceptance Criteria and Reported Device Performance

The FDA's substantial equivalence determination implies that the reprocessed devices perform functionally similar to the predicate devices. |
| Cleaning Validation | Reprocessing procedures effectively clean the device to remove biological and other contaminants. | "Process validation testing was done to validate the cleaning [...] procedures." |
| Sterilization Validation | Reprocessing procedures effectively sterilize the device, rendering it free of viable microorganisms. | "Process validation testing was done to validate the [...] sterilization procedures." |
| Packaging Validation | Repackaged device maintains sterility and integrity until point of use. | "Process validation testing was done to validate [...] the device's packaging." |
| Visual and Functional Inspection | Each reprocessed device meets quality standards before release. | "In addition, the manufacturing process includes visual and functional testing of all products produced." |
| Substantial Equivalence (Overall) | The reprocessed device is as safe and effective as a legally marketed predicate device. | "SterilMed's Reprocessed Stone retrieval baskets are substantially equivalent to: Boston Scientific Corporation's Stone Dislodger Baskets (K970121, K951309, K936721), Wilson-Cook Medical Inc.'s Stone Extractor (K851965), The counterpart devices from the original manufacturers."

This conclusion is based on "...these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and principles of operation." |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document states "Representative samples" were used for bench testing and process validation. A specific numerical sample size is not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's bench testing and process validation, it's likely internal laboratory testing conducted by SterilMed, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable to this type of submission. "Ground truth" for this device relates to objective physical and biological properties (e.g., cleanliness, sterility, mechanical function) rather than expert interpretation of data. The validation work would be conducted by qualified engineers and microbiologists, but they are not "experts establishing ground truth" in the same way as, for example, radiologists interpreting images.

4. Adjudication method for the test set

• This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations or annotations, typically in fields like medical imaging. The tests performed here (bench testing for function, process validation for cleaning/sterilization) involve objective measurements and established protocols, not subjective expert judgment 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, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device, not an AI/ML diagnostic or assistive tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used

• The "ground truth" here is based on objective measurements and validated protocols demonstrating device function, cleanliness, sterility, and packaging integrity. This is derived from:
  • Bench test results (e.g., mechanical performance specifications).
  • Microbiological testing results (e.g., sterility assurance levels, residual protein/bioburden).
  • Packaging integrity tests.
  • Visual and functional inspection criteria.

8. The sample size for the training set

• This concept is not applicable. There is no "training set" as this is not an AI/ML algorithm.

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

• This concept is not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

Ask a specific question about this device

The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.

The AMS Foreign Body Extractor is made of stainless steel and consists of an obturator, sheath, grasper, seals, handle, security clip, telescope stabilizers and ACMI adaptor ring. The AMS Foreign Body Extractor Accessory Kit contains replacement security clip, telescope stabilizers, ACMI adaptor ring, and seals. To facilitate insertion into the urethra and bladder, the obturator is placed inside the sheath. Once inside the bladder, the obturator is removed and the grasper is placed within the lumen of the sheath. The handle is then attached and the telescope inserted into the sheath. The grasping jaws are operated by moving the handle to open and close the grasping jaws to capture and remove the foreign body.

The provided document, a 510(k) Premarket Notification for the AMS Foreign Body Extractor, describes the device and its intended use but does not contain detailed acceptance criteria or a comprehensive study demonstrating that the device meets specific performance criteria through clinical trials or extensive bench testing with quantifiable results.

The document states:

• "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."
• "All components are verified to ensure that only those meeting all parameters are released for sale."

However, it does not provide the specifics of these "descriptive data," "test plan," "test results," or the "parameters" used for verification. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer many of the subsequent questions based solely on the provided text.

Here's what can be inferred and what is missing:

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

Regarding the study that proves the device meets the acceptance criteria:

The document describes "Bench Testing" but provides no details on the study design, sample sizes, or specific results. It only states: "American Medical Systems has provided descriptive data on the test plan and test results for the Foreign Body Extractor. These data support that the function and characteristics of the device are suitable for its intended use."

Here's a breakdown of the other requested information based on the provided text, highlighting what is unavailable:

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

• Sample size: Not specified.
• Data provenance: Not specified. It's likely bench testing conducted by American Medical Systems, Inc. in Minnetonka, MN, USA. However, whether "descriptive data" implies internal prospective testing or retrospective analysis is not stated.

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/Not specified. The testing described appears to be bench testing, not involving expert interpretation or ground truth establishment in a clinical sense.

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

• Not applicable/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

• Not applicable. This device is a surgical instrument, not an AI-based diagnostic tool.

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

• Not applicable. This is a manual surgical instrument.

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

• Not specified. For bench testing, "ground truth" would likely refer to engineering specifications and performance metrics (e.g., grasping force, retraction distance, material strength).

8. The sample size for the training set

• Not applicable. This is a direct-use medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable.

Ask a specific question about this device

The intended use for the foreign body grasping forceps is in urological procedures to endoscopically remove, manipulate or grasp calculi (i.e. stones) and other foreign objects.

The COMEG Endoscopy devices that we intend to market are foreign body Grasping Forceps. These forceps are composed of stainless steel. They have diameters of 7 and 9 French and lengths of 40 cm. Each model has an alligator jaw with a standard double action mechanism.

The provided text is a summary of safety and effectiveness for grasping forceps (K970489) and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or any details about AI/algorithm performance. It primarily focuses on the regulatory submission details for a medical device (grasping forceps) in 1997, comparing it to a legally marketed substantially equivalent device.

Therefore, I cannot extract the requested information based on the provided input. The document describes a medical device and its intended use, rather than a study evaluating device performance against acceptance criteria using expert-reviewed data.

Ask a specific question about this device

Ask a specific question about this device

Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

The Bard® Platinum Class™ 3 French Ureteroscopic Instrument product line consists of three separate instruments or stone dislodgers: the Flat Wire Stone Basket, the High-Torque Helical Stone Basket, and the Grasping Forceps. These instruments are each constructed of three main assemblies: a handle assembly, shaft assembly, and stone capture mechanism consisting of an expandable basket or grasping forceps assembly. Stone dislodgers (baskets or grasping forceps) may be used in the removal of renal and ureteral stones and calculi by inserting the stone basket or grasping forceps (while in a closed position) through the working channel of an endoscope and into the ureter or renal pelvis. The tip of the basket or forceps is advanced past the stone and the expandable basket or forceps is opened, manipulated and closed around the stone, thereby capturing it for removal. Once the stone has been captured, the basket or forceps should be partially closed to keep the stone from dislodging while the device and endoscope are being withdrawn. The devices have a 3 Fr. outer diameter shaft size and each is available in three different lengths, 70cm, 90cm and 115cm.

This K961248 document describes a medical device submission for the Bard® Platinum Class™ 3 French Flat Wire Stone Basket, High-Torque Helical Stone Basket, and Grasping Forceps, intended for the endoscopic removal of renal and ureteral stones and calculi.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Submitter's Information: Details of C. R. Bard, Inc.
• Device Names: Trade and common names, classification names.
• Predicate Device Names: Mentions the same devices as predicate.
• Device Description: Explains the construction and general use of the stone baskets and grasping forceps.
• Intended Use: Specifies the indications for each type of instrument.
• Technical Characteristics: Lists the biocompatible materials used in construction.

Therefore, I cannot provide the requested table or study details based on the information given. This document is a 510(k) Summary of Safety and Effectiveness Information, which typically summarizes the device and its intended use, rather than detailing the full extent of performance testing and acceptance criteria. Such detailed study information is usually found in the full 510(k) submission, which is not provided here.

Ask a specific question about this device