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The Boss Crossing Support Catheter (Boss CSC) is indicated to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The proposed device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018" and 0.035" guidewires, respectively. Both catheter shafts are composed of a high modulus thermoplastic material in a monolithic single layer construction. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. Like the predicate, Terumo NaviCross Support catheters, the distal end of the Boss CSC catheter is equipped with an RO marker band to enable visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity.

The 2.4Fand 3.9F catheters are packaged together in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. There are two versions of the device offered:

1. 3.9F/90cm length catheter packaged with a 2.4F/135cm length catheter
2. 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter

As stated, the 2.4F and 3.9F catheters are packaged together. Each catheter is individually inserted into a spiral HDPE protective hoop which is then secured to an HDPE backer card. The two catheter hoops and backer card are inserted into a Tyvek/Mylar pouch that is then placed into a cardboard outer shelf box. Five (5) individual pouches are then placed in a cardboard shelf box.

The provided text describes a medical device, the Boss Crossing Support Catheter (Boss CSC), and the testing conducted to support its substantial equivalence to predicate devices. However, it does not include the specific details you've requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document discusses various bench tests and biocompatibility tests to demonstrate the device's physical performance, material safety, and sterility. These tests are conducted to ensure the device performs as intended and is safe for use, but they are not related to the performance of an AI/ML diagnostic or assistive device that would have metrics like sensitivity, specificity, or reader improvement.

Below is a breakdown of why this document cannot provide the information you're looking for, and where such information would typically be found for an AI/ML device:

Reason for lack of requested information:

This 510(k) submission is for a physical medical device (a catheter), not an AI/ML-driven diagnostic or assistive technology. Therefore, the concepts of "acceptance criteria" as you've defined them (e.g., sensitivity, specificity, human reader improvement), "test set sample size," "ground truth establishment," or "multi-reader multi-case studies" are not applicable to this particular submission.

What is included (and would be equivalent for a physical device):

• Acceptance Criteria & Reported Performance: The document lists various performance tests (e.g., Kink Resistance, Tensile Strength, Flow Rate, Leak Test, Hydrophilic Coating Integrity, etc.). For each of these, the "acceptance criteria" would be defined in the test protocols (e.g., "no kinks observed under X force," "tensile strength > Y N," "flow rate within Z ml/min"). The "reported device performance" would be the actual measured values from these bench tests. The document states "The Boss CSC catheters submitted in this 510(k) have demonstrated similar performance characteristics to the predicate devices" and "The performance of the Boss CSC Catheters demonstrates substantial equivalence to the performance of the predicate devices," implying these criteria were met.
• Sample Size for Test Set: For physical devices, this would refer to the number of catheters tested for each performance characteristic. The document doesn't specify the exact number of devices tested for each bench test, but it notes "Testing was performed on aged and non-aged Boss CSC catheters."
• Data Provenance: Not applicable in the AI/ML sense. Data comes from bench testing of the manufactured device.
• Experts / Ground Truth: Not applicable for physical device performance. The "ground truth" is the physical measurement itself. For example, a "kink" is a directly observable physical event.
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance: The "standalone" performance for a physical device refers to its ability to meet its functional specifications directly, which is what the bench tests evaluate.
• Type of Ground Truth: Direct physical measurements and observations from bench testing.
• Sample Size for Training Set: Not applicable (no AI/ML model to train).
• How Ground Truth for Training Set was Established: Not applicable.

Hypothetical Example (if this were an AI/ML device):

If the Boss Crossing Support Catheter were, for instance, an AI-powered system designed to detect potential anatomical blockages during catheter insertion by analyzing real-time imaging, the requested information would look something like this:

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

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

• Sample Size: 500 patient cases (250 with blockages, 250 without), comprising 1500 image frames.
• Data Provenance: A multi-center retrospective dataset collected from hospitals in the United States (70%), Germany (20%), and Japan (10%).

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

• Number of Experts: 3
• Qualifications:
  • Expert 1: Interventional Radiologist, 15 years experience in peripheral vascular interventions, board certified.
  • Expert 2: Vascular Surgeon, 12 years experience, specializes in complex peripheral revascularization.
  • Expert 3: Interventional Cardiologist, 10 years experience, with a focus on peripheral artery disease.

4. Adjudication method for the test set

• Adjudication Method: 2+1 (Two experts independently reviewed each case. If they agreed, that was the ground truth. If they disagreed, a third senior expert was brought in to make the final decision).

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

• MRMC Study Done: Yes
• Effect Size: Average increase of 0.07 in ROC AUC (from 0.81 without AI to 0.88 with AI assistance) across all readers for detecting blockages, and a 15% reduction in reading time without compromising accuracy.

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

• Standalone Performance Done: Yes, as reported in the table above (Sensitivity 92.5%, Specificity 84.1%).

7. The type of ground truth used

• Type of Ground Truth: Expert Consensus (adjudicated by 3 experts based on angiographic images and clinical reports).

8. The sample size for the training set

• Training Set Sample Size: 10,000 patient cases (approximately 30,000 image frames).

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

• Ground Truth for Training Set: Established by a team of 5 clinical residents and 2 junior interventional radiologists, with periodic audits and quality checks performed by a senior interventional radiologist. Cases flagged for ambiguity were escalated for consensus review by senior staff. Pathology reports and outcomes data were sometimes used as secondary confirmation where available for specific types of blockages.

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The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.

The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.

This document describes the non-clinical performance testing for the BOSS 8F Balloon Guide Catheter, a medical device. There is no information regarding a study of an AI device. As such, I cannot provide details on factors like sample size, ground truth, expert qualifications, or comparative effectiveness studies related to AI.

However, I can provide the acceptance criteria and reported device performance based on the non-clinical bench testing for the BOSS 8F Balloon Guide Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is uniformly reported as "Pass" for all tests, indicating that "All samples met the pre-determined acceptance criteria" or similar outcomes for biocompatibility (e.g., "Noncytotoxic," "Non-hemolytic"). The reference standards listed for each test effectively serve as the basis for the acceptance criteria.

The following information is Not Applicable (N/A) as the provided document describes non-clinical performance testing for a physical medical device (catheter), not an AI/Software as a Medical Device (SaMD).

2. Sample size 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 bench testing of a physical device.
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. "Ground truth" in this context would refer to objective material properties or performance under specified conditions, measured by instrumentation.
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. The "ground truth" for this device's testing is implicitly defined by the quantifiable limits and observable characteristics specified in the referenced ISO and FDA standards.
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 BOSS Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The BOSS Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS Balloon Guide Catheter is a 90 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.

This document is a 510(k) Summary for the BOSS™ Balloon Guide Catheter, a medical device. It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices, which means no clinical studies were required. Therefore, the information typically associated with AI/ML device studies (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance) is not applicable here as this is a medical device, not an AI/ML diagnostic tool.

The "acceptance criteria" for this device are the pre-determined thresholds for various physical, functional, and biocompatibility tests, as detailed in the "NONCLINICAL PERFORMANCE TESTING SUMMARY" and "Biocompatibility Testing Summary" sections. The "study that proves the device meets the acceptance criteria" refers to the successful completion of all these non-clinical (bench and animal) tests.

Here's a breakdown of the requested information based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" or similar for the non-clinical bench tests. While the exact numerical sample size for each test is not explicitly listed, it implies that a sufficient number of devices were tested to meet the requirements of the referenced standards (e.g., ISO 10555-1, FDA guidances). For the animal study, the sample size is not specified but it states "an acute porcine model."
• Data Provenance:
  • Country of Origin: Not specified for the bench tests. The animal study used an "acute porcine model."
  • Retrospective or Prospective: All testing was prospective, designed specifically to evaluate the device against established standards and criteria for regulatory submission.

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

This information is not applicable. The "ground truth" for this medical device 510(k) submission is established by the performance standards (e.g., ISO, ASTM, FDA guidances) and the physical properties of the device itself (e.g., dimensions, strength, material characteristics). Experts were involved in setting these standards and conducting the tests, but not in the "ground truth" establishment in the sense of labeling data for an AI/ML model for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results in the context of an AI/ML model. The "adjudication" is inherent in whether the device "passes" or "fails" the pre-defined engineering and performance criteria.

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

Not applicable. This is a medical device (catheter) and the submission is based on non-clinical performance and substantial equivalence to predicate devices, not an AI/ML diagnostic tool requiring MRMC studies.

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

The "ground truth" in this context is based on:

• Established international and national standards for medical devices (e.g., ISO 10555 series, ISO 10993 series, AAMI, ASTM).
• FDA guidance documents for specific device types (e.g., PTCA Catheters).
• Pre-determined engineering specifications and performance criteria for the device.
• Results from a non-GLP (Good Laboratory Practice) animal study.

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. There is no training set for this device.

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Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.

Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for an AI/algorithm-based medical device.

The document is a 510(k) premarket notification for the BOSS Toe Fixation System, which is a physical implant (a hemi-arthroplasty implant for the metatarsophalangeal joint).

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance (for an algorithm)
• Sample size used for the test set and the data provenance (for an algorithm)
• Number of experts used to establish the ground truth for the test set and their qualifications (for an algorithm)
• Adjudication method (for an algorithm's ground truth)
• 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
• If a standalone performance study was done (for an algorithm)
• The type of ground truth used (for an algorithm)
• The sample size for the training set (for an algorithm)
• How the ground truth for the training set was established (for an algorithm)

The document focuses on demonstrating substantial equivalence to an existing predicate device based on its indications for use, operating principle, materials, instrumentation, packaging, sterilization, and non-clinical tests (mechanical strength, cadaveric evaluation, bacterial endotoxins test). These tests are standard for a physical implant, not for an AI/algorithm.

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8-15 mmHg Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8
10-20 mmHg Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility.
15-20 mmHg Moderate Firm - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs - Helps prevent deep vein thrombosis for long distance travelers and edema
20-30 mmHg - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling - Helps prevent deep vein thrombosis for long distance travelers and edema
30-40 mmHg Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema - Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy

Not Found

This document is a 510(k) clearance letter for "Bossong Hosiery Medical Support Stockings." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information on acceptance criteria, a study proving device performance against those criteria, or any of the detailed study parameters requested (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance). The letter is a regulatory approval document and not a scientific study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided document.

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BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

DEVICE COMPONENTS AND OPERATION:

• 1. Insulated Handle:
     The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.

There are two flow control mechanisms so the flow of saline (one directly on the handle and a roller clamp just proximal to the handle). Saline flow can be regulated by the user within the sterile field. The saline delivery tubing is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

• 2. Shaft and Electrode Tip:
     The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.

These devices use technology substantially equivalent to the Aquamantys SS4.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the utilization of high frequency radiofrequency energy and saline.

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

These devices conform to the requirements of safety standard IEC 60601-2-2. There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices. There are no new questions raised regarding safety or effectiveness.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence. It focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and a comprehensive study report with clinical performance metrics as one might find for a novel device or a clinical trial. Therefore, some of the requested information (especially regarding clinical performance, expert involvement for ground truth, and human-in-the-loop studies) is not present in this type of regulatory submission and cannot be extracted.

Acceptance Criteria and Device Performance Study for BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for clinical performance. The "acceptance criteria" here are implicitly related to meeting the fundamental safety and effectiveness requirements by being similar to already approved devices. The "study" refers to the comparison made against the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical "test set" with a specific sample size in the way one would for a clinical trial assessing performance. The evaluation is based on a comparison to predicate devices, focusing on technological equivalency, intended use, and safety standards. Therefore, there is no discrete sample size used for a test set or information on data provenance (e.g., country of origin, retrospective/prospective) in the context of clinical performance data in this 510(k) summary. The "test" is largely a comparison of specifications and design to the predicates, combined with compliance to safety standards.

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

This information is not provided as the submission is a 510(k) for substantial equivalence and does not detail a study where expert-established ground truth for a test set would be required for performance evaluation in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical "test set" requiring adjudication.

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

This information is not applicable/not provided. The device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human cognitive performance or AI assistance would not be relevant.

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

This information is not applicable/not provided. The device is a surgical instrument and does not involve standalone algorithm performance in the context of AI or diagnostic imaging.

7. The Type of Ground Truth Used

The 'ground truth' in this 510(k) context is implicitly the established safety and effectiveness of the predicate devices (TissueLink: Aquamantys 2.3 Bipolar Sealer and 6.0 Bipolar Sealer, and Aquamantys SS4.0 Bipolar Sealer). The submission aims to demonstrate that the new device operates similarly and meets the same safety profiles as these already approved devices. Therefore, the "type of ground truth" is regulatory approval and established performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. As explained, the device is an electrosurgical tool, not an AI or machine learning model that would require a "training set."

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

This information is not applicable/not provided for the reasons stated in point 8.

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The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.

Not Found

This is a medical device marketing authorization from the FDA for a powered wheelchair, the "Scout Boss." It is not a study describing a device that uses AI/ML or an algorithm-based diagnostic. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document.

This document is a 510(k) clearance letter, which means the device (a powered wheelchair) was found to be "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often through engineering tests and comparisons rather than clinical studies in the context of diagnostic accuracy.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Not Found

This document package is a 510(k) premarket notification decision letter from the FDA regarding a vacuum erection device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device, named "Boss-2000-3 Vacuum Erection Device (Over-the-Counter Use)", is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information.

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The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

Not Found

The provided document is a 510(k) premarket notification approval letter for the "Boss-2000-2 Vacuum Erection Device." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

This letter primarily focuses on the regulatory determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It outlines general regulations and responsibilities but does not detail performance data, study designs, or acceptance metrics.

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

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