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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.

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The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.

The Coaxial Accordion ERCP Device is a medical device intended for the endoscopic removal of stones in the biliary system and for contrast injection.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states "Performance Data: Not required" for this 510(k) submission. This indicates that Percutaneous Systems, Inc. did not conduct a specific performance study with defined acceptance criteria for this device. Instead, the device's clearance was based on demonstrating substantial equivalence to predicate devices already on the market.

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

Since a dedicated performance study was "Not required," there is no test set sample size or data provenance information provided in this submission for the Coaxial Accordion ERCP Device itself.

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

This information is not applicable as no dedicated performance study using a test set was conducted.

4. Adjudication Method for the Test Set

This information is not applicable as no dedicated performance study using a test set was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not conducted as no dedicated performance study was required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical device (biliary catheter), not an algorithm or AI product. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

This information is not applicable as no dedicated performance study was conducted.

8. The Sample Size for the Training Set

This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device that requires a training set.

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

This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device.

Summary of Device Acceptance and Study:

The Coaxial Accordion ERCP Device gained market clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices:

• Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc.
• Fusion Extraction Balloon with Multiple Sizing, Cook Medical

The study that proved the device met the acceptance criteria was the substantial equivalence comparison. This comparison focused on demonstrating that the Coaxial Accordion ERCP Device has the same intended use, indications for use, principles of operation, and very similar technological characteristics as the already legally marketed predicate devices. Because of this similarity, the FDA determined that a separate, dedicated performance study with specific acceptance criteria was "Not required" for this submission. The assumption of substantial equivalence implies that the new device carries the same safety and effectiveness profile as the predicate devices that have established performance.

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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."

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The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.

This document, K061766, is a 510(k) premarket notification for a medical device called the "Expressway Intermittent Catheter." The submission states that performance data is "Not required." This is because the device is being marketed as substantially equivalent to a legally marketed predicate device (SLIP Urology Catheter, Percutaneous Systems, Inc.) based on having the same intended use, indications for use, principles of operation, and technological characteristics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not provided in this submission, as no new performance studies were deemed necessary for this type of submission.

Here's a breakdown of why each section cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "Performance Data: Not required."
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance testing was required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was required.
4. Adjudication method for the test set: Not applicable, as no performance testing was required.
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 urological catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a urological catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance testing was required.
8. The sample size for the training set: Not applicable, as no 'training set' in the context of performance data would be relevant for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

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The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.

This document is a 510(k) summary for the CYSTOGLIDE INTRODUCER SHEATH, a medical device. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, the provided text does not contain the kind of detailed information requested about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment that would be present for an AI/ML device.

The "Performance Data" section merely states: "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices." This is a qualitative statement of equivalence, not a presentation of specific metrics against predefined acceptance criteria.

Based only on the provided text, I cannot complete the requested tables and information.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices." This is the core 'performance' claim. However, the specific acceptance criteria (e.g., a threshold for friction, ease of insertion, durability) that would define "no significant difference" are not detailed in this 510(k) summary.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable to this type of device submission. The device is a physical introducer sheath, not an AI/ML diagnostic tool using expert-labeled images/data.

4. Adjudication method for the test set:

• 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/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not applicable in the context of AI/ML ground truth. The "ground truth" for this device would be its physical properties and clinical function (e.g., lubricity, strength, biocompatibility), which are typically assessed through bench testing and potentially limited human use studies, but not in the sense of 'ground truth' for an AI model.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to facilitate the dilation of urethral strictures and the introduction of catheters or instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and as a guide for urological catheters or instruments and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film, a sheath, a stabilizing hub and a dilator. The device can be front-loaded onto a urological guidewire.

The provided 510(k) summary for the CYSTOGLIDE DILATING INTRODUCER SHEATH does not contain specific acceptance criteria or a detailed study proving the device meets explicit performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." This means the device's performance was compared to existing, legally marketed devices, rather than against predefined, quantitative acceptance criteria.

Therefore, providing a table of acceptance criteria and reported device performance as requested, along with details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not possible based on the information given. The document does not provide these types of details because the approval pathway is substantial equivalence, not a demonstration of meeting specific performance endpoints.

However, I can extract and summarize the available information related to performance and study references:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only refers to "Performance data."

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

• Not applicable/Not specified. The document does not describe a study involving human expert evaluation for establishing ground truth or performance.

4. Adjudication method 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 physical medical device (dilating introducer sheath), not an AI/software device that would involve human readers or comparative effectiveness studies with AI assistance.

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

• Not applicable. This is a physical medical device.

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

• Not applicable/Not explicitly stated. The "performance data" likely refers to bench testing or animal model studies assessing physical properties and functionality mimicking the intended use, rather than clinical ground truth as understood in diagnostic AI/imaging studies. The comparison is to a predicate device's performance.

8. The sample size for the training set

• Not applicable. This is for a physical device, not an algorithm requiring a training set.

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

• Not applicable.

Summary based on available information:

The 510(k) submission for the CYSTOGLIDE DILATING INTRODUCER SHEATH demonstrates substantial equivalence based on a comparison to predicate devices, specifically stating "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." The document does not provide details on quantitative acceptance criteria, specific study designs (e.g., sample sizes, provenance), expert involvement, or AI-related metrics as it pertains to a physical medical device rather than a diagnostic algorithm or AI system.

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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.

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The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The UPDATED SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The UPDATED SLIP Urology Introducer Sheath consists of a membrane sheath, outer tube, stabilizing ring, and an obturator. The outer tube is pre-loaded with the membrane sheath.

The provided text describes a 510(k) premarket notification for a medical device, the "UPDATED SLIP Urology Introducer Sheath." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a detailed clinical study with acceptance criteria, sample sizes, and expert evaluations as typically seen for novel or higher-risk devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this specific submission.

Here's a breakdown of the available information:

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

• Acceptance Criteria: Not explicitly stated as performance metrics with numerical targets. The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This is a qualitative statement, not a numerical performance value against a defined criterion.

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

• Sample Size: Not specified. The document refers to "Performance data" but does not detail the nature, size, or methodology of any testing that generated this data.
• Data Provenance: Not specified.

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. This type of expert assessment to establish ground truth for a test set is not typically part of a 510(k) submission for a device like an introducer sheath, which is focused on physical and functional equivalence rather than diagnostic accuracy or specific clinical outcomes requiring expert interpretation.

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

• Not Applicable. As no specific "test set" and expert ground truth establishment are described, there is no adjudication method.

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. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance. This device is an introducer sheath, a different class of medical device, and does not involve AI or human readers in the way an MRMC study would assess.

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

• Not Applicable. This device is not an algorithm or AI system. It is a physical medical device.

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

• Not Applicable. For this type of device and submission, the "ground truth" equivalent would be the established performance and safety profile of the predicate device, against which the new device is compared in terms of its technological characteristics and the absence of new safety/effectiveness questions.

8. The sample size for the training set

• Not Applicable. Training sets are relevant for AI/machine learning models. This device is not an AI/ML product.

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

• Not Applicable. (See point 8).

Summary of what is known from the document regarding "performance data":

The document explicitly states: "Performance data demonstrated no significant difference in the performance of the UPDATED SLIP Urology Sheath and the predicate device." This indicates that some form of comparative evaluation was conducted to support the claim of substantial equivalence. However, the details of what kind of performance data (e.g., mechanical strength, lubricity, insertion force, biocompatibility), how it was collected, the sample size, or the specific methodology are not provided in this summary. For a 510(k), this level of detail is typically found in the full submission, not necessarily in the brief summary provided. The focus of the 510(k) is on the device's technical characteristics and intended use being similar to a legally marketed predicate device, ensuring no new questions of safety or effectiveness are raised.

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The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.

The provided text, a 510(k) summary for the MICROVERTER Ureteral Access Sheath, states that "Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device." However, it does not explicitly list acceptance criteria nor detail the study that proves the device meets specific criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices were deemed to meet performance and safety requirements, and the new device is substantially equivalent, it is also considered to meet those requirements.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for any performance testing or the provenance (e.g., country of origin, retrospective/prospective) of the data. It merely mentions "Performance data."

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

The document does not mention the involvement of experts to establish ground truth for any test set.

4. Adjudication Method:

The document does not describe any adjudication method as it does not detail a study involving expert assessment of a test set.

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

The document does not mention or describe a MRMC comparative effectiveness study. As such, no effect size for human reader improvement with AI assistance can be reported. The device itself is a medical tool, not an AI diagnostic system.

6. Standalone Performance Study:

The document does not explicitly describe a standalone (algorithm only) performance study. The "Performance data" mentioned is likely a comparison of the device's functional characteristics to the predicate device, rather than an "algorithm only" study, as this is a physical medical device.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used. Given the nature of the device (ureteral access sheath), "ground truth" would likely relate to objective measurements of physical properties, functionality (e.g., ease of introduction, lubricity, fluid injection capabilities, integrity), or potentially in-vivo performance in animal models, rather than expert consensus on images or pathology. However, specific details are not provided.

8. Sample Size for the Training Set:

The concept of a "training set" is generally applicable to machine learning or AI models. Since this is a physical medical device and the document doesn't indicate the use of AI, the notion of a training set as typically understood does not apply in this context. The document does not provide information on any "training set" sample size.

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

As the concept of a training set is not applicable (see point 8), the document does not describe how ground truth for a training set was established.

Summary of the Study (as inferred from the 510(k) Summary):

The "study" referenced in the 510(k) summary is not described in detail but broadly refers to the generation of "Performance data." The primary objective of presenting this data was to demonstrate that the MICROVERTER Ureteral Access Sheath has "no significant difference in the performance" compared to its predicate devices (PSI SLIP Urology Introducer Sheath, Cook Flexor Ureteral Access Sheath, Boston Scientific Navigator Ureteral Access Sheath). This approach is standard for 510(k) submissions, where substantial equivalence to legally marketed predicate devices is the pathway to clearance. The specific methods, sample sizes, or detailed results of this performance evaluation are not provided in the publicly available summary.

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The SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

The SLIP Urology Catheter consists of a sheath, pusher tube, a twist ring, and a guide ring. The pusher tube is pre-loaded with the sheath.

This 510(k) summary is for a medical device (SLIP Urology Introducer Sheath) seeking substantial equivalence to a predicate device, not for an AI/ML-driven device that typically undergoes performance studies with acceptance criteria, test sets, and ground truth establishment.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not applicable to this document.

Here's an explanation based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts "identicality" to a predicate device rather than presenting new performance data against specific criteria.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): Not applicable. No performance study, as typically understood for new AI/ML devices, was conducted or presented.
• Type of Ground Truth: Not applicable. This concept is relevant for performance studies where a reference standard is needed to evaluate the device's output. Since no new performance data was provided, no ground truth was established for the SLIP Urology Introducer Sheath.
• Training Set Sample Size and Ground Truth Establishment (for training): Not applicable. This device is not an AI/ML model requiring a training set.

Summary of what can be extracted from the document:

The core of this 510(k) submission is based on substantial equivalence.

• Device: SLIP Urology Introducer Sheath
• Predicate Device: Memcath's Urology Introducer Sheath
• Key Argument for Substantial Equivalence: The submitter states: "The SLIP Urology Introduction Sheath is identical to the Memcath Urology Introduction Sheath (except for the trade name). The SLIP Urology Introduction Sheath has the same intended use, indications for use, technological characteristics, and principles of operation."
• Performance Data: "No performance data were provided" because the device is claimed to be identical to the predicate.

In a traditional 510(k) for a device like this, the 'study' to prove it meets acceptance criteria is often a comparison to a legally marketed predicate device demonstrating that it's just as safe and effective, without raising new questions of safety or effectiveness. For an identical device, the "acceptance criteria" can implicitly be considered "is identical to the predicate."

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