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The Prosurg's Neo-Arthroscope ™ -Digital Video Arthroscopic System (which includes Digital Video Arthroscope, Single use Outer Sheath is intended to provide an internal view or image of the interior of a joint through surgical opening during examination, diagnostic / operating, arthroscopic / endoscopic treatment procedures including examination, diagnostic & surgical procedures for treatment of knee, shoulder, ankle, elbow, Hip, wrist (Carpel Tunnel Syndrome), hand, TMJ (Temporal Mandibular Joint), Spine, Disc and feet (Planter fascia Release) using surgical devices and accessories.

The Single Use Digital Video Arthroscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end or in the sidewall, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the distal end of the Arthroscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The Single Use Neo- Arthroscope is designed to be completely isolated from irrigation and suction fluid pathways. The design of sealed distal end and proximal end of the outer sheath / cannula also prevents any fluid or tissue contact with Neo-Arthroscope.

The Neo-Arthroscope ™ - Digital Video Arthroscopic System consists of four main components:

• (a) Digital Video Arthroscope with CMOS Sensor & Built-in LEDs / Fiber optic. (Patient Contact Item)
• (b) Single Use, Outer Sheath / Cannula with Suction / Irrigation, a separate, dedicated channel for insertion of video Arthroscope and /or Trocar for insertion. (Patient Contact Item)
• (c ) Laptop /Tablet computer with windows Operating System, TV monitor module and Video processing Software. (Commercially Available, Non patient Contact Item)
• (d) USB 2.0 / HD Connecting Cables. (Commercially Available, Non Patient Contact Item)

The provided document focuses on the 510(k) premarket notification for the "Neo-Arthroscope™ - Single Use Digital Video Arthroscopic System." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a statistical performance against acceptance criteria in the context of a diagnostic AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in this document. This document describes a medical device (an arthroscope) and its physical and functional characteristics, not software or AI performance.

The document describes "Performance Testing (Bench Testing)" but these tests are for the physical device's safety and effectiveness, not for a diagnostic algorithm's accuracy.

Here's what can be extracted regarding the device's validation from the provided text:

Performance Testing (Bench Testing) Categories:

The manufacturer, Prosurg, conducted performance testing (Bench Test Evaluation) as per FDA Guidance Document to demonstrate the safety and effectiveness of the Neo-Arthroscope™ device for its intended use. The following tests were completed:

• Dimensional Measurements (Outer Diameter, Working Length)
• Field of View (in air)
• Image Resolution (Number of Pixels)
• Direction of View
• LED Brightness, Voltage & Current measurement.
• USB / HD Connection compatibility with Laptop / Tablet / Monitor
• Electrical Safety Test (IEC 601-1)
• Electromagnetic Compatibility (IEC 601-1-2)
• Thermal (Heat) Temperature at the Distal Tip (LED)
• Product Labeling & IFU Requirements & Accuracy
• Packaging Integrity & Sterility Assurance Test
• Accelerated Aging Test (one Year)
• Sterilization Assurance Level (ISO 11135-1:2007)
• ETO Residual Levels (ISO 10993-7:2008)
• Biocompatibility (ISO 10993-1:2009)

Conclusion from the document:
"The results of the performance testing demonstrate that proposed Neo- Arthroscope Single Use Digital Video Arthroscopy system performs as well as predicate device and is considered safe and effective for its intended use."

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The performance tests listed are general safety and engineering specifications, not statistical performance metrics for decision-making.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device clearance, not an AI algorithm. The "test set" here refers to physical performance tests of the arthroscope itself.
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 (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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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The Prosurg's Neo-Bronchoscope™ - Digital Video Bronchoscopy System -Rigid & Flexible (which includes Digital Video Bronchoscope, Single view (Volto Sheath) is intended for use for use for use for use for use for use for use for use for use for use for use for use for use for examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices and accessories.

The Single Use Digital Video Bronchoscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB Connector at the proximal end. The distal end of the Bronchoscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The NeoFlex™ - Bronchoscope , Flexible Video Bronchoscope device with an Articulating Tip is designed with built-in fluid suction / irrigation and working channel for Micro Instrument delivery.

The Neo- Bronchoscope ™ Video Bronchoscopy System consists of four main components:

• (a) Digital Video Bronchoscope (Rigid / Flexible) with CMOS Sensor & Built-in LEDs / Fiber optic.
• (b) Single Use. Rigid Diagnostic / Operating Outer Sheath with Suction / Irrigation / Instrument channel and a separate, dedicated channel for video Bronchoscope insertion. Or a flexible Bronchoscope with suction / Irrigation & Instrument channel with Articulating tip deflection.
• (c ) )Laptop /Tablet computer with windows Operating System, Video Module and Video processing Software. (Commercially Available, Not supplied by Prosurg, Inc)
• (d) USB 2.0 / HD / S-Video Connecting Cables. (Commercially Available, Not supplied by Prosurg, Inc)

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Neo-Bronchoscope Digital Video Bronchoscopy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily describes bench testing performed to demonstrate safety and effectiveness, rather than specific performance metrics against pre-defined acceptance criteria with numerical targets. It lists the types of tests conducted.

Missing Information: The document states that these tests were "completed to demonstrate safety & effectiveness," but it does not provide the specific acceptance criteria (e.g., "Field of View must be > X degrees") nor the quantitative results from these tests. It only lists the types of tests performed.

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

The document explicitly states that "Prosurg has conducted performance testing (Bench Evaluation - As per FDA Guidance Document) of Neo- Bronchoscope™ device." This indicates that the testing was performed on physical devices in a laboratory setting.

• Sample Size: The document does not specify the sample size of devices used for the bench tests.
• Data Provenance: The data provenance is from bench testing conducted by Prosurg, Inc. The document does not mention human subject data, therefore, the concepts of "country of origin of the data," "retrospective or prospective" do not apply in the context of this summary.

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

This information is not applicable as the study described is a series of bench tests on the device's physical and functional properties, not a clinical study involving diagnosis or interpretation by experts. Therefore, no ground truth established by experts is mentioned in this context.

4. Adjudication Method for the Test Set:

This information is not applicable as the described study is a series of bench tests and does not involve human interpretation or 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:

This information is not applicable. The document describes the premarket notification for a bronchoscope, which is a medical device for direct visualization. There is no mention of AI or human reader improvement with or without AI assistance.

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

This information is not applicable. The device is an endoscope, which is directly operated by a human. It does not involve any algorithms functioning in a standalone capacity (without human-in-the-loop performance) that would be assessed.

7. The Type of Ground Truth Used:

As noted above, the study involved bench testing of device specifications and safety parameters. The "ground truth" for such tests would be the engineering specifications and regulatory standards (e.g., IEC 601-1, ISO 11135-1, ISO 10993-7, ISO 10993-1) that the device must meet.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes the premarket notification for a medical device that does not appear to involve machine learning or AI, and therefore would not have a "training set" in the computational sense. The "training" here refers to the manufacturing and design process.

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

This information is not applicable for the same reason as point 8.

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The Prosurg's Neoscope 3D™ -3D Digital Video Endoscopic System ( Rigid & Flexible) is intended to provide "Real -Time" 3D images and video to surgeons for endoscopic examination, diagnosis and treatment for Minimally Invasive surgical Procedures within Abdominal and Female Reproductive organs, using surgical devices and accessories.

The Neoscope 3D™ -3D Digital Video Endoscope design consists of two CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB / HD Connector at the proximal end. The distal end of the 3D Endoscope containing two CMOS sensors and LEDs / Fiber optic is protected by sealed, clear window to prevent any fluid passageway within 3D Endoscope. The NeoScope flex 3D ™ - Flexible Video Endoscopic device is designed with Articulating / Deflecting Distal tip controlled by lever mechanism in the handle.

The Single Use. NeoScope 3D™ - Rigid and Flexible models are provided sterile for use by physician. The Rigid Neoscope 3D is designed to provide zero (0) degree, thirty (30) degree and forty five (45) degree field of view. The Neoscope flex 3D™ Flexible endoscope is designed to provide minimum 90 degree tip deflection & field of view.

The NeoScope 3D ™- 3D Digital Video Endoscopic System (Rigid / Flexible) consists of four main components:

(a) Digital Video Endoscope with two CMOS Sensor & Built-in LEDs / Fiber optic in Stainless steel Tube. Or Single Use, NeoScope flex 3D- Flexible Endoscope with Articulating / Deflecting Distal Tip. (Patient Contact Item)

(b) Video Processing Module with USB 2.0 / 3.0 / HD / DVI connecting ports. (Commercially Available, Non -Patient contact item)

(c) 3D Laptop /Tablet computer with windows Operating System, 3D Monitor / 3D TV, USB 2.0 /3.0 / HD / S-Video Connecting Cables. (Commercially Available, Non- patient contact item)

The Single Use Neoscope 3D Video Endoscope consists of CMOS (2) imaging sensors & LED mounted at the distal tip. The 3D Laptop / Tablet computers is designed to power Imaging Sensors and LED. The Neoscope 3D is provided Sterile, for Single use only.

The provided document is a 510(k) summary for the NeoScope 3D™ - 3D Digital Video Endoscopic System. It outlines the device description, indications for use, technological characteristics, and a summary of performance testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define acceptance criteria as a quantitative threshold or present a detailed study with specific performance metrics against those criteria in the way one might expect for an AI algorithm performance study.

Instead, the performance testing section lists types of tests conducted to ensure safety, effectiveness, and substantial equivalence, rather than a statistical evaluation of diagnostic accuracy. The FDA's review concludes that the device is "substantially equivalent" based on these tests.

Since the document does not relate to an AI/ML algorithm or a diagnostic device where acceptance criteria typically refer to metrics like sensitivity, specificity, or AUC, many of the requested points are not applicable or cannot be extracted from the provided text.

Here is an attempt to address your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that are typically reported for AI/ML diagnostic devices. Instead, it lists various performance tests conducted to demonstrate the device's safety, effectiveness, and substantial equivalence to legally marketed predicate devices. The "reported device performance" is implicitly that the device passed these tests and was found substantially equivalent.

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

This information is not provided in the document. The performance testing appears to be bench testing on the device itself (e.g., measuring dimensions, resolution, electrical properties) rather than testing on a "test set" of patient data.

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

This information is not provided and is not applicable to the type of performance testing described (bench testing of an endoscopic system).

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not done and is not applicable, as this device is an endoscopic system providing 3D images, not an AI-assisted diagnostic tool for interpretation by human readers.

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

A standalone performance study for an algorithm was not done and is not applicable. The device itself is an imaging system designed for human-in-the-loop use by surgeons.

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

The concept of "ground truth" (in the context of diagnostic accuracy) is not applicable here. The "truth" for the performance tests listed would be the established engineering specifications, safety standards, and compliance with regulatory requirements. For example, the ground truth for "Dimensional Measurements" would be the engineering drawing specifications.

8. The sample size for the training set

This information is not provided and is not applicable, as this is hardware device clearance, not an AI/ML algorithm requiring a training set.

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

This information is not provided and is not applicable, as this is hardware device clearance, not an AI/ML algorithm requiring a training set with established ground truth.

Summary Explanation:

The provided document is a 510(k) premarket notification for a medical device (NeoScope 3D™ - 3D Digital Video Endoscopic System) that allows surgeons to visualize endoscopic procedures in 3D. The "acceptance criteria" and "performance study" described are focused on demonstrating that the physical device meets its specifications, safety standards (e.g., electrical safety, biocompatibility), and regulatory requirements, and that it is "substantially equivalent" to previously cleared predicate devices.

This is fundamentally different from a study proving the diagnostic performance of an AI/ML algorithm, which would involve evaluating its accuracy (e.g., sensitivity, specificity) against a clinical ground truth on a test set of patient data. Therefore, many of the questions asked, which are highly relevant for AI/ML device evaluations, do not apply to the traditional hardware device clearance described in this FDA document.

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The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ Digital Video System (which includes the Digital video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

The Prosurg's Neoscope (Hysteroscopce) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Prosurg, Inc. regarding their NeoScope™ Digital Video Endoscopic System. This document does not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, sample sizes, or expert qualifications.

The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing Prosurg, Inc. to market it. It outlines general regulations and compliance requirements but does not include any performance data or study specifics of the kind requested.

Therefore, I cannot provide the requested table and information based on the input text.

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Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children.

Specific Indications for Use:

• . Fractures of the cranium, mid-face, maxilla and chin.
• . Infant craniofacial surgery ( i.e. Craniosynostosis, Congenital malformations)
• . Le Forte ( I, II, III ) Osteotomies.
• . Pediatric Reconstructive procedures of Cranial facial Skeleton
• . Orthognathic or Reconstructive procedures of mid-face, maxilla & chin.
• Facial Craniotomy flap fixation. .

Adjustable Bone Plates™- Bioabsorbable, Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable, Self Compression Bone Fixation plates, meshes, fixation screws, fasteners, tacks, tenion wires and anchor pins designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable, self compression, Bone fixation plates are offered in various sizes and configurations to meet anatomical needs of the patients. TheAdjustable Bone Plates™- Bioabsorbable Craniofacial Bone Fixation plates, mesh, screws .tension wires, tacks and anchor pins are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ). The bone plates and meshes are designed to be used with 1.8mm and 2.1 mm screws, tacks and anchor pins for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm conventional screw driver or deployed with endoscopic device.

The provided text describes a 510(k) premarket notification for a medical device and not a study that evaluated an AI/ML device. Therefore, the requested information for acceptance criteria and a study proving the device meets them, specifically in the context of AI/ML, cannot be fully extracted.

However, I can provide the information that is present concerning the device's comparison to a predicate device, which is a form of "acceptance criteria" for 510(k) submissions.

Here's a breakdown of what can be extracted, heavily acknowledging the limitations:

No AI/ML device is described in the provided text. The device is a physical craniofacial bone fixation system.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified quantitatively. The text only mentions "Preclinical testing was performed" and "Laboratory product testing has indicated that the Adjustable Bone Plates™..." It does not provide specific numbers of units tested for mechanical properties.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is "Preclinical testing" and "Laboratory product testing", suggesting controlled lab environments rather than clinical data.

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

• Not applicable. This relates to diagnostic interpretation, which is not relevant for a physical bone fixation system. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication method for the test set

• Not applicable. This also pertains to expert interpretation, not physical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This type of study is for evaluating human performance, often with or without AI assistance, in diagnostic tasks. The device described is a physical implant.

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

• No. This refers to AI/ML algorithm performance. The device is a physical product.

7. The type of ground truth used

• Direct physical measurement/bench testing. The "ground truth" for the mechanical properties (tensile strength, breakage force, degradation time, pull force during installation) was established through laboratory testing and measurement of the device itself.

8. The sample size for the training set

• Not applicable. The device is not an AI/ML system that requires a "training set."

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

• Not applicable. As above, no training set for an AI/ML model is involved.

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The CranioClamp™ - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "CranioClamp™ - Bioabsorbable Cranial Bone Flap Fixation System." This type of document does not contain the detailed information required to describe acceptance criteria and a study proving those criteria are met.

Here's why and what kind of information is missing based on your request:

• Focus of a 510(k) letter: The letter primarily states that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It confirms regulatory class, product codes, and general controls. It does not delve into the specific details of the performance testing or clinical studies conducted by the manufacturer.
• Missing information: All the points you've asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are typically found in the manufacturer's 510(k) summary document or the full 510(k) submission, not in the FDA's clearance letter itself.

Therefore, based only on the provided text, I cannot answer your request.

To provide the information you're seeking, I would need access to the full 510(k) submission document or the publicly available 510(k) summary for K071138, which would detail the performance data and the studies conducted.

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General Indication for Use: Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children. Specific Indications for Use: - Fractures of the cranium, mid-face, maxilla and chin. - Infant craniofacial surgery (i.e. Craniosynostosis, Congenital malformations) . - Le Forte ( I, II, III ) Osteotomies. . - Pediatric Reconstructive procedures of Cranial facial Skeleton . - Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. ● - Facial Craniotomy flap fixation. ●

Xsorb™ Bicabsorbable Craniofacial Bone Fixation System & Accessories consists of single use, bioabsorbable Bone Fixation plates, meshes, fixation screws, fastners and tacks designed for use in trauma and reconstructive procedures for craniofacial skeleton, mid-face, maxilla and chin in adult and children. The single use, bioabsorbable Bone fixation plates and meshes are offered in various sizes and configurations to meet anatomical needs of the patients. The Xsorb™ - Bioabsorbable Craniofacial Bone Fixation pltaes & screws / wires are made from bioabsorbable co-polymer material of Poly (L -Lactide & DL-Lactide-70:30 or 85:15 ) . The bone plates and meshes are designed to be used with 1.8mm screws and 2.1 mm emergency screws for trauma and reconstructive procedure. The bioabsorbable screws can be tightened with 1.8mm screw driver.

The provided text describes a 510(k) submission for the Xsorb™ Bioabsorbable Craniofacial Bone Fixation System & Accessories. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not typically a study proving performance against strict acceptance criteria like those for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of submission.

However, I can extract information related to "performance data" as mentioned in the document for the device itself, rather than an AI/ML algorithm.

Here's a breakdown of the requested information based on the provided text, focusing on what is available and noting what is not applicable for this type of device clearance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the way an AI/ML study would define performance thresholds (e.g., specific sensitivity/specificity targets). Instead, it refers to the device performing "as intended" and being "satisfactory" compared to predicate devices. The "performance" is based on mechanical testing.

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

• Sample Size for Test Set: Not specified. The performance data section refers to "Preclinical testing" and "Laboratory product testing," which typically involves specific test articles (e.g., plates, screws) but doesn't quantify a "sample size" in terms of cases or patients as an AI/ML study would.
• Data Provenance: Not specified. This relates to laboratory testing of the physical device, not patient data derived from a specific geographic location.
• Retrospective or Prospective: Not applicable. The testing described is mechanical/laboratory testing of the device itself.

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

• Not applicable. This device is a physical craniofacial fixation system, not an algorithm that requires expert ground truth labeling. Performance is assessed through mechanical properties.

4. Adjudication method for the test set

• Not applicable. This is not an AI/ML study requiring adjudication of expert opinions.

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. This is not an AI/ML device, so an MRMC study is not relevant or performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not applicable / Mechanical Properties. The "ground truth" for this device's performance is objective mechanical measurements (tensile strength, breakage force, degradation time) compared against established standards for predicate devices or biomechanical requirements for the intended application.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.

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MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.

The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.

The provided text details a 510(k) summary for the MiniSling™ device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, the document does not contain a comprehensive study proving the device meets specific acceptance criteria in the format typically associated with a clinical trial or a detailed performance validation report. Instead, it relies on preclinical testing and comparison to legally marketed predicate devices for substantial equivalence.

Here's a breakdown of the information that can be extracted from the provided 510(k) summary, structured to address your request as much as possible, while also highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document states that "Preclinical testing was performed," but it does not specify what the quantitative acceptance criteria for "satisfactory performance," "tensile strength," or "breakage force" were. It only states that the device met these unquantified criteria and that the tensile strength and breakage force were "equal or more than the predicated devices."

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

The document does not provide details on the sample size used for the preclinical testing. Therefore, the data provenance (e.g., country of origin, retrospective/prospective) cannot be determined from this text.

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

This information is not provided in the 510(k) summary. The preclinical testing described appears to be laboratory-based mechanical testing, not a study involving expert assessment or clinical ground truth establishment in the typical sense.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described is preclinical mechanical testing, not a study requiring adjudication of expert interpretations.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on preclinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This is not applicable and not mentioned. The device is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the preclinical testing described is based on predefined mechanical and performance parameters (e.g., tensile strength, breakage force, pull force) measured in a laboratory setting. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this safety and effectiveness summary.

8. Sample Size for the Training Set

This information is not applicable and not provided. As this is a physical device, not an algorithm or AI system, there is no "training set" in the context of machine learning.

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

This information is not applicable and not provided, for the same reasons as above.

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The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)

LaserTx™ - Diode Laser & Delivery System

The provided text is a 510(k) clearance letter for a medical device called the LaserTx™ - Diode Laser & Delivery System. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended uses and indications for the device.

It does not contain information about acceptance criteria, device performance metrics, clinical study design (sample size, data provenance, ground truth establishment, adjudication methods), or multi-reader multi-case comparative effectiveness studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study design elements you specified based solely on this document. The document confirms that the device is cleared for marketing based on its substantial equivalence to an existing predicate device, but it does not detail the specific performance validation data for the current device.

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TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.

TURBT- RF electrodes and Electrosurgical devices

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA to Prosurg, Inc. for "TURBT-RF electrodes and Electrosurgical devices." This document primarily discusses the regulatory approval of the device based on substantial equivalence to predicate devices. It does not contain any information regarding:

• Acceptance criteria or reported device performance for a study.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Ask a specific question about this device