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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

The provided document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed External Fixation Devices. It declares substantial equivalence to predicate devices but does not contain specific acceptance criteria or a study proving that the device meets such criteria.

The document states:
"Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
"Vanguard Reprocessed External Fixation Devices are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics."

Based on the provided text, I cannot complete the requested table and details because the information is not present. The document focuses on demonstrating substantial equivalence based on the identical technological characteristics and intended performance to predicate devices rather than providing detailed acceptance criteria and a study with specific performance metrics.

Therefore, the questions cannot be answered from the provided text.

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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.

External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

Rods. Rails and Modular Rails ~ Straight rods and rails are external fixation devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.

Rings and Ring Segments ~ Rings and ring segments are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.

Ring-to-Rod/Rail Clamps ~ Ring-to-rod/rail clamps are utilized to connect a Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or ring-to-wire clamps u Ring-to-Fin of Ring-to-Wire Or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.

Rod/Rail-to-Screw Clamps ~ Rod/Rail-to-screw clamps are utilized to 8 Rour Ran-to-Screw - Califfer - Califfer - Station raily affixed to the bone. connect an excential rination fail to a proscrews that are anchored in the bone.

DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.

Rail-to-Rail Couplings ~ Rail-to-Rail couplings are multi-element . Components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.

Rod-to-Rail Couplings ~ Rod-to-Rail couplings are multi-element . Kou-to-Kan - Couplines
components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.

Rod-to-Rod Couplings ~ Rod-to-Rod couplings are multi-element 제 Device components used to connect one rod to another in a range of positions Description defined by the individual clamp configuration. They are designed to (continued) denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rail-to-Clamp Couplings ~ Rail-to-clamp couplings are multi-element 트 components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rod-to-Clamp Couplings ~ Rod-to-clamp couplings are multi-clement 8 components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Clamp-to-Clamp Couplings ~ Clamp-to-clamp couplings are multi-element 해 components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel.

The provided text is a 510(k) summary for Vanguard Reprocessed External Fixation Devices. It describes the devices, their indications for use, and declares substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification, Product Codes.
• Predicate Devices: Listing the original equipment manufacturers and their trade names.
• Indications for Use: What the reprocessed devices are intended for.
• Contraindications: When the devices should not be used.
• Device Description: Detailed breakdown of components like rods, rings, clamps, and couplings, including materials (anodized aluminum, stainless steel, carbon fiber).
• Technological Characteristics: Stating that the reprocessed devices are essentially identical to OEM devices and perform as intended after cleaning, packaging, and performance testing.
• Conclusion: A declaration of substantial equivalence to predicate devices.
• FDA Approval Letter: Confirming the 510(k) clearance.
• Catalog Pages: Listing specific models, their descriptions, and materials.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement based on the provided text.

The statement "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective" is a summary conclusion, but the actual data, methods, acceptance criteria, or results of these tests are not present in this document. This kind of detailed study information is often found in the full 510(k) submission, which is typically much more extensive than the public summary.

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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used non-invasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight and curved rods, rod-to-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-to-rod, and ring-to-pin clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

The provided text describes a 510(k) summary for VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES but does not contain acceptance criteria for device performance nor any study details that prove the device meets such criteria.

The document primarily focuses on:

• Identification of the device: Vanguard Reprocessed External Fixation Devices, along with its classification, common name, and product code.
• Predicate devices: Listing of original equipment manufacturers (OEM) and third-party reprocessors for comparison.
• Indications for Use and Contra-indications: Specifies the medical conditions the device is intended to treat and situations where it should not be used.
• Device Description: Detailed explanation of the components of external fixation systems (rods, couplings, rings, clamps) and their materials.
• Technological Characteristics: States that the reprocessed devices are "essentially identical" to OEM devices and perform the same.
• Test Data (mentioned, but not detailed): A generic statement that "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, no specific acceptance criteria or results from these tests are provided.
• Conclusion: A declaration of substantial equivalence to predicate devices based on the information provided.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes, ground truth details, or specific study information because this information is not present in the provided document.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g., evaluation of arrhythmias or cardiac mapping.

Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The distal tip segment of the catheter is capable of unidirectional steering through manipulation of the hand piece. This remote manipulation of the distal tip segment facilitates precise positioning of the electrode array. The catheters are available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters:

The provided text (510(k) summary) describes a device undergoing FDA clearance, specifically a reprocessed medical device. For such devices, the primary focus of the regulatory submission is to demonstrate that the reprocessed device is substantially equivalent to its original, new counterpart (the predicate device). This often means demonstrating that the reprocessing does not negatively impact the device's original performance, safety, or effectiveness.

It is important to note that this document does not describe a study involving AI or machine learning. Therefore, many of the requested points related to AI-specific evaluation (multi-reader multi-case studies, standalone algorithm performance, AI specific ground truth, training data) are not applicable.

Here's the information extracted and interpreted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Criteria: For reprocessed devices, the acceptance criteria are generally to demonstrate equivalence to the predicate device in terms of safety, effectiveness, and functional performance after reprocessing. The specific quantitative criteria for each performance aspect (e.g., electrical impedance within a certain range, mechanical durability) are typically detailed in the underlying test reports, but only a summary statement is presented in the 510(k) summary.

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

The 510(k) summary does not specify the sample size for the performance and biocompatibility testing. It only states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing" were conducted.

• Data Provenance: The studies were internal company validations and testing. The document doesn't specify if clinical data (e.g., from human patients) was used, but implies lab-based performance and biocompatibility testing relevant to the device itself. Given it's a reprocessed medical device, the focus is typically on whether the reprocessing impacts the device's physical and functional properties, rather than new clinical trials with human subjects.

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

This concept is not directly applicable in the context of this 510(k) summary. The "ground truth" for demonstrating substantial equivalence of a reprocessed device typically relies on validated laboratory testing methods and engineering analyses compared against the specifications of the original device, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, microbiologists, and other technical professionals specializing in sterilization, material science, and device performance testing. Their qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of diagnostic findings. Adjudication would not be a relevant concept for the performance testing of a reprocessed medical device's physical and functional characteristics.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-powered diagnostic tool, but rather a reprocessed diagnostic electrophysiology catheter. The concept of human readers improving with AI assistance is not relevant here.

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 is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the original design specifications and performance characteristics of the predicate device (EP Technologies EPT-Dx™). The reprocessed device must demonstrate that its performance (e.g., electrical properties, mechanical integrity, biocompatibility, sterility) meets these original specifications after reprocessing. The types of ground truth involved would be:

• Instrumental measurements: For performance characteristics like electrical conductivity, mechanical strength, dimensional accuracy.
• Chemical analysis: For material composition and degradation.
• Microbiological testing: For sterility and endotoxin levels.
• Biocompatibility testing: According to ISO standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being "trained" for this device.

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

Not applicable.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 - 8 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The catheters are available with various steerable distal curves for remote manipulation of the distal tip segment to facilitate precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream. In clinical use, diagnostic electrophysiology catheters are placed under fluoroscopy within the heart, near major structures of the conduction system. The effects of pacing on the conduction system and time intervals between waveforms are recorded, measured, and compared to baseline and normal values. The electrocardiogram normally has atrial, His, and ventricular components in order to obtain accurate interval measurements which are used to establish the baseline and current status of the conduction system.

This document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It describes the device, its indications for use, and a conclusion of substantial equivalence to predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective.

Specifically, the provided text is for a medical device (reprocessed catheters) and not an AI/ML powered device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "Test Data" section only generally states: "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." It does not provide any specific acceptance criteria or study details.

Since the input document is for a non-AI/ML device, I cannot fill out the requested information.

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When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.

Not Found

The provided text is a 510(k) clearance letter from the FDA for reprocessed arthroscopic wands. It confirms that the devices are substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving that the device meets such criteria in terms of performance metrics.

The letter explicitly refers to "supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002," and mentions that the FDA "reviewed your supplemental validation data." However, the content of that validation data, including acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or details of any comparative effectiveness studies, is not included in this clearance letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document acts as an approval notice, not the study report itself.

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Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.

Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 5-15cm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.

Trocar Obturator is available in shielded and non-shielded configurations sized 5-15mm. Models equipped with a safety shield are designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury. Non-shielded optical obturators are equipped with a clear tip and an 11-12mm video laparoscopy channel to allow trocar insertion under direct visual guidance and minimize the risk for internal injury.

The provided text describes a 510(k) summary for Vanguard Reprocessed Dilating Tip and Blunt Trocars. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the reprocessed device. Therefore, much of the requested information regarding detailed study design, statistical analysis, and clinician-based performance metrics is not available within this document.

Here's an attempt to answer based on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."

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

The document does not specify a separate "test set" in the context of evaluating algorithm performance or diagnostic accuracy. It refers to "cleaning, sterilization, packaging validations, and performance and biocompatibility testing" as the basis for demonstrating safety and effectiveness.

• Sample Size: Not specified for each type of testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's likely these were laboratory or bench tests conducted by Vanguard Medical Concepts, Inc.

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

Since this is a reprocessed medical device approval, not an AI/diagnostic software approval, the concept of "ground truth" derived from experts in a clinical diagnostic context does not apply in the same way. The ground truth for the reprocessed device's safety and effectiveness would be established through:
* Bench testing: Measuring physical properties, functional performance against specifications.
* Sterilization validation: Demonstrating sterility.
* Biocompatibility testing: Ensuring material safety.

No "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy are mentioned or relevant here.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic study requiring expert adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC comparative effectiveness study was done, as this is a device reprocessing approval for physical instruments, not a diagnostic AI or imaging interpretation system requiring human-in-the-loop performance evaluation.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

As this concerns a reprocessed physical device, the "ground truth" refers to established engineering standards, material science specifications, and regulatory requirements for sterility and biocompatibility.

• Engineering Specifications: Functional performance validated against the original equipment manufacturer's (OEM) device specifications.
• Sterility Assessment: Meeting established sterility assurance levels (e.g., 10^-6).
• Biocompatibility Standards: Adherence to ISO 10993 or similar standards.
• Cleaning Efficacy Standards: Demonstrating removal of organic and inorganic contaminants to acceptable levels.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

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

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Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

A Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.

Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-100mm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.

Trocar Obturator is available in bladed and non-bladed configurations sized 5-15mm. Bladed models are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated so as to reduce the risk for vascular or visceral injury.

Non-Bladed obturators have either a rounded (blunt) tip or sharply tapered (dilator) tip to allow trocar insertion following a cut down and minimize the risk for internal injury.

Vanguard receives previously used trocars from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.

This document describes the reprocessing of previously used trocars by Vanguard Medical Concepts, Inc. The submission is for "Vanguard Reprocessed Bladed and Non-Bladed Trocars" (US Surgical/AutoSuture Series). It outlines the device description, technological characteristics, and a conclusion of substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., "device must achieve X% accuracy"). Instead, it describes a demonstration of equivalence and performance through various validations. The "performance" is implicitly stated as performing "as intended" and being "safe and effective."

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

The document does not specify the exact sample size used for performance testing of the reprocessed devices. It broadly mentions "cleaning, test data, biocompatibility testing."

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given this is a 510(k) for a reprocessed medical device, the testing would likely be a combination of in-house (Vanguard Medical Concepts) laboratory testing and potentially contract lab testing, using the specific devices being reprocessed.

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

This type of information is generally not applicable to a 510(k) submission for reprocessing a medical device like a trocar. The "ground truth" for these devices is typically established through engineering specifications, regulatory standards, and performance characteristics of the original predicate device. Expert panels are not usually used to establish "ground truth" for the functionality of a reprocessed instrument, but rather to evaluate the clinical impact or equivalence. The document does not mention any expert panels.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human judgment is involved in establishing a definitive diagnosis or outcome, for example, in medical imaging studies. For the performance testing of a physical medical device, objective measurements against specifications are used, not human adjudication in this sense.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human readers' performance is compared with and without AI assistance across multiple cases. This submission is for the reprocessing of a surgical instrument.

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

Not applicable. A "standalone" performance study refers to the performance of an AI algorithm alone. This submission is for a reprocessed medical device, not an AI algorithm. The device itself is "standalone" in the sense that its functionality is evaluated independently of human surgical skill, but this is a different context than what is meant by "standalone" for AI.

7. The Type of Ground Truth Used

The ground truth used for this type of device (reprocessed trocars) would be:

• Engineering Specifications and Performance Standards: The reprocessed devices must meet the design and performance specifications of the original predicate devices (e.g., seal integrity, blade sharpness, safety shield function, structural integrity).
• Regulatory Standards: Adherence to FDA guidance for reprocessed single-use devices, including sterility, biocompatibility, and cleaning validation.
• Predicate Device Performance: The original predicate devices set the benchmark for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. A "training set" refers to data used to train an AI algorithm. This submission is for a reprocessed medical device, not an AI algorithm.

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

Not applicable, as there is no training set mentioned in the context of an AI algorithm. The "ground truth" for the processes (cleaning, sterilization, etc.) would be established by validated scientific methods and regulatory requirements for medical device reprocessing.

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The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.

The provided text is a 510(k) summary for a reprocessed medical device, specifically a Hand-Activated Ultrasonic Scalpel. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and biocompatibility testing of the reprocessed device itself, rather than a clinical study evaluating its performance against specific acceptance criteria.

As such, none of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies is present in the provided text. The document is about the reprocessing process validation and comparison of device characteristics to those of new predicate devices, not about a clinical performance study with AI.

However, I can extract the available information which primarily relates to the device itself and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or clinical efficacy. The implicit acceptance criterion is that the reprocessed device performs "as intended" and is "safe and effective," demonstrating substantial equivalence to the original predicate devices without negative impact due to reprocessing. This is shown through the following:

  • Technological Characteristics Equivalence: Device materials, specifications, and technological characteristics are equivalent to OEM devices.
  • Performance and Test Data: Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate the reprocessed devices perform as intended.

• Reported Device Performance:

  • Device Description: Functions to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. 5mm diameter, 36cm functional length, pistol-type grip, 360° rotation, curved active blade, integrated push buttons for power control.
  • Equivalence Claim: Vanguard Reprocessed Hand-Activated Ultrasonic Scalpels are "essentially identical" and "substantially equivalent" to currently marketed Original Equipment Manufacturer (OEM) devices.

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

• The document describes validation and testing of the reprocessed device itself (e.g., cleaning, sterilization, biocompatibility, performance), not a clinical study on patient data. Therefore, there is no "test set" in the context of patient data; instead, there are batches of reprocessed devices tested.
• The sample sizes for these internal device validation tests are not specified in the provided text.
• Data provenance: Not applicable in the context of clinical patient data. The testing is internal to Vanguard Medical Concepts, Inc. (later Ascent Healthcare Solutions).

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 document pertains to the regulatory clearance of a reprocessed medical device, not an AI or diagnostic study requiring expert-established ground truth on patient data.

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

• Not applicable. As above, this is not a study assessing diagnostic performance where adjudication of ground truth would be needed.

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 document does not describe any AI component or human-in-the-loop performance evaluation.

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

• No. This document is about a reprocessed surgical instrument, not an algorithm or AI system.

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

• Not applicable in the context of clinical AI performance. The "ground truth" for the device's performance is established through engineering and biological safety testing (e.g., sterility testing, material strength testing, biocompatibility assays) to ensure it meets specifications and performs equivalently to new devices.

8. The sample size for the training set

• Not applicable. There is no AI component or "training set" of data described.

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

• Not applicable. There is no AI component or "training set" of data described.

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The Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down.

The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade.

Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.

The provided documentation is a 510(k) Summary for the Vanguard Reprocessed Ultrasonic Scalpel. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a performance study.

Here's what can be inferred from the provided text, and what is explicitly missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The "acceptance" for this regulatory submission is demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: The document states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." However, it does not provide specific performance metrics (e.g., cutting force, coagulation time, re-use cycle durability) or the numerical results of these tests against any pre-defined acceptance criteria.

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

• Missing: This information is not provided. The document mentions "performance and biocompatibility testing" but offers no details about the sample sizes of devices tested, the type of data collected, or its origin.

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: This is not applicable in the context of this 510(k) submission. The "ground truth" here is typically established through engineering and laboratory testing for reprocessing efficacy and device function, not through expert consensus on diagnostic images or clinical outcomes.

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

• Missing: Not applicable for this type of submission.

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 is not relevant to this device. This device is an ultrasonic surgical scalpel, not an AI-powered diagnostic tool.

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

• No: This is not an AI algorithm. It is a reprocessed physical medical device.

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

• Inferred Ground Truth: For a reprocessed surgical instrument, the "ground truth" would typically involve:
  • Cleaning efficacy: Absence of residual biological material (e.g., protein, hemoglobin) after reprocessing, confirmed by laboratory assays.
  • Sterilization efficacy: Confirmation of sterility (e.g., sterility assurance level, bacterial endotoxin testing).
  • Functional performance: Verification that the reprocessed device performs according to OEM specifications (e.g., cutting ability, coagulation, instrument articulation, electrical isolation) through mechanical and electrical testing.
  • Biocompatibility: Confirmation that reprocessing does not introduce cytotoxic or allergenic residues.
• Explicitly Stated: The document refers to "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."

8. The sample size for the training set:

• Missing: This document is not about an AI device that would have a training set.

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

• Missing: Not applicable as it's not an AI device.

Summary of what the document focuses on:

The entire submission focuses on establishing substantial equivalence to existing, legally marketed ultrasonic scalpels. The core argument for substantial equivalence of the reprocessed device rests on:

• Identical Technological Characteristics: "The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed Ultrasonic Scalpels possess identical technological characteristics."
• Demonstrated Safety and Performance: Through "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing."

The 510(k) process for a reprocessed device primarily requires demonstrating that the reprocessing method reliably restores the device to its original performance specifications and that the device remains safe and effective for its intended use, without significantly altering its fundamental technology or indications for use. It does not typically involve the kind of elaborate clinical or AI performance studies requested in the prompt.

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