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To provide irrigation during endoscopic surgical procedures

Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.

Here's an analysis of the provided text regarding the Spyglass Irrigation System's acceptance criteria and study, structured to address your specific points:

The provided 510(k) summary for the Spyglass Irrigation System offers very little detail regarding specific acceptance criteria or a comprehensive study demonstrating direct performance against those criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

• Intended Use
• System Components
• Flow rate adjustments
• Min/max flow rate
• Min/max Pressures
• Pump Type |

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

• Sample Size for Test Set: Not mentioned. The document only states "Bench testing was performed." It doesn't specify if this involved multiple devices, repeated trials, or a representative sample.
• Data Provenance: Not mentioned. Given the nature of a 510(k) submission and "bench testing," it's highly likely to be internal R&D data from the manufacturer (Medical Scientific Corporation) in the USA. It is prospective testing, as it's for premarket notification.

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

• Not applicable/Not mentioned. The testing described is "bench testing," which typically involves objective measurements by engineers or technicians against specifications, rather than expert judgment for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The described testing is bench testing, which doesn't involve this type of adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document focuses on technical bench testing and comparison to a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an irrigation pump, not an AI-assisted diagnostic tool.

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

• Yes, in a sense, a standalone evaluation was performed through "bench testing." This type of testing assesses the device's technical specifications and functionality independent of direct human operational variables beyond standard use. However, it's not an "algorithm only" study as the device is mechanical/electronic, not AI-driven.

7. Type of Ground Truth Used

• Bench Test Specifications/Predicate Device Data: The ground truth for the bench testing would be the pre-defined technical specifications for flow rate, pressure, and operational parameters, often benchmarked against the predicate device's known performance characteristics.

8. Sample Size for the Training Set

• Not applicable/Not mentioned. The Spyglass Irrigation System is a medical device, not an AI/machine learning algorithm, so it doesn't have a "training set" in the conventional sense of data used to train a model.

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

• Not applicable. As there's no training set for this type of device, no ground truth needed to be established for it.

Summary of Study limitations based on the provided text:

The provided document (a 510(k) summary) is very high-level and intentionally brief. It aims to demonstrate substantial equivalence, not to provide a detailed report of all validation testing. Key information regarding specific performance metrics, the methodology of the "bench testing," sample sizes, and detailed acceptance criteria are omitted for brevity in this public summary. Such details would be present in the full 510(k) submission, which is not publicly available in this format.

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To provide irrigation during endoscopic surgical procedures

Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.

The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data for the SpyGlass Irrigation System.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance study details as might be found in a full clinical trial report or engineering validation document.

Here's what can be extracted and what is missing based on your template:

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

Missing: Specific numerical values for flow rate ranges, pressure ranges, or other quantifiable performance metrics are not detailed in this summary. The acceptance criteria essentially appear to be "substantially equivalent to the predicate device" in these identified characteristics.

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

Missing. The document only states "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended." It does not describe any specific test set, sample size, or data provenance.

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)

Missing. No information on expert involvement or ground truth establishment is provided.

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

Missing. No information on adjudication methods is provided.

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 an irrigation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

Not Applicable. This is a hardware irrigation system, not a software algorithm.

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

Missing. The concept of "ground truth" as typically applied to AI or diagnostic studies is not directly applicable or discussed for this irrigation hardware device. Performance would likely be evaluated against engineering specifications and predicate device performance.

8. The sample size for the training set

Missing. No training set is mentioned as this is a hardware device, not a machine learning model.

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

Not Applicable. See point 8.

Summary of the Study (Based on the Provided Text):

The document submitted for the SpyGlass Irrigation System (K063700) is a 510(k) summary. The primary "study" or justification presented is a comparison of technological characteristics to demonstrate substantial equivalence to predicate devices (Endogator Endoscopy Irrigation Pump - K060962, K031773).

The comparison covered:

• Intended Use
• System Components
• Flow rate adjustments
• Minimum/maximum Pressures
• Pump Type

The statement "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended" indicates that some internal testing was conducted, but the details of this testing (e.g., methodology, results, data, sample sizes, specific acceptance criteria beyond "performs as intended") are not included in this public 510(k) summary. The FDA's letter confirms that based on the information provided, the device was found substantially equivalent to predicate devices.

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The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.

The provided text describes a 510(k) summary for the "CSS" (Coagulation Device) a modification to the MSI Bipolar Sheath. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific quantitative or qualitative acceptance criteria beyond "substantially equivalent" and "no new safety/efficacy concerns."
• Detailed performance metrics (e.g., coagulation time, tissue effect, safety margins for specific power differences).
• Actual data demonstrating how the device met these criteria.

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

• Sample Size: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified. It's bench testing, so likely conducted in a lab setting, but no country of origin is mentioned. The testing is retrospective, as it's for verification of a device.

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

• Not applicable. The study involved bench testing, not human interpretation or clinical data requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set:

• Not applicable. As this was bench testing, there's no mention of an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This device is an accessory for surgical procedures, and the testing described is bench testing, not a clinical study involving human readers interpreting cases.

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

• Yes, in a way. The "bench testing" can be considered a standalone performance evaluation of the device itself (not an algorithm), without human-in-the-loop performance influencing the device's basic functionality. However, it's not "algorithm only" as there's no explicit algorithm described.

7. The Type of Ground Truth Used:

• For the bench testing, the "ground truth" would be engineering specifications and design input requirements for functionality, materials, and power characteristics. This is based on engineering/design specifications for the device.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

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

• Not applicable, as no training set is mentioned.

In summary, the provided document describes a 510(k) submission for a medical device accessory (CSS) that relies on demonstrating substantial equivalence through bench testing to established predicate devices. It does not provide the detailed study design, specific acceptance criteria, or quantitative results typical of studies for novel devices or AI/software as a medical device (SaMD).

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The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars

The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.

The provided document is a 510(k) premarket notification for the Evanesce Scar Management System, a silicone elastomer sheeting intended for the topical management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria and performance data for the new device itself.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Here's why and what information is present:

• 510(k) Summary: The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through comparison of indications for use, technological characteristics, and safety and effectiveness information with the predicate.
• Predicate Device: The document identifies "SCAR HEAL" (510(k) K971468) from Specialty Systems, Inc. as the predicate device.
• Device Description and Intended Use: These are provided for the Evanesce Scar Management System, highlighting it as a sheet of soft, flexible, translucent silicone elastomer for over-the-counter topical treatment of hypertrophic and keloid scars.
• FDA Letter: The FDA's letter confirms their review and finding of "substantial equivalence" to devices marketed prior to May 28, 1976, allowing the device to be marketed. This letter signifies regulatory clearance, but it does not detail specific performance studies of the Evanesce system.

To answer your request, if this were a document that contained such information, it would typically look like this (hypothetical example, NOT from the provided text):

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

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