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The Hansen Medical Sensei® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include a series of software enhancements and a new E-Stop button.

The provided document is a 510(k) summary for the Hansen Medical Sensei X Robotic Catheter System. It describes a device that is an updated version of a previously cleared device. Therefore, the "study" described is a design verification and validation testing to confirm that the modifications do not alter the substantial equivalence of the device to its predicate.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All of the pre-determined acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves or the specific quantitative results for each test. It only lists the types of testing performed.

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

The document does not specify the sample sizes used for the software, E-Stop, or system testing. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

This information is not mentioned in the provided text. The testing described appears to be engineering verification and validation against design specifications, rather than clinical efficacy studies requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are engineering and functional checks, not involving interpretation by multiple experts.

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

A MRMC comparative effectiveness study was not conducted (or at least, not described in this document). The document explicitly states: "No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes." This indicates that no studies comparing human readers with and without AI assistance were performed or deemed necessary for this 510(k) submission.

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

This is not applicable as the Sensei X Robotic Catheter System is a robotic control system for catheters, inherently designed for human-in-the-loop operation, not a standalone AI algorithm. The described testing is primarily focused on the functional performance of the system and its components (software, E-Stop).

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned (Software Testing, E-Stop Button functional testing, System testing) would be based on the design specifications and requirements of the device. For example, for software testing, the ground truth would be that the software performs according to its functional and performance specifications. For E-Stop testing, the ground truth would be that the button successfully halts the system as designed. This is engineering verification, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not describe an AI model with a training set. The Sensei X Robotic Catheter System is a robotic control system with software enhancements, but it's not presented as an AI/ML device that learns from a training dataset in the way a diagnostic algorithm would.

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

This is not applicable as no training set for an AI model is described.

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Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour

Silicone Malar Implant – For the augmentation or reconstruction of the malar contour

Silicone Chin Implant -- For the augmentation or reconstruction of the chin contour

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the Hanson Medical Facial Implants. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily serves as an FDA clearance letter for a medical device, which is different from a study report detailing performance metrics.

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For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

The Monarch Nasal Implant is a Class II Device. The Monarch Nasal Implant is available in 48mm and 44mm lengths and is 1cm wide at the ends. The thickness is 1.5mm to 2mm around the edges. The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique. The Monarch Nasal Implant is comprised of ePTFE and Medical Grade Titanium Alloys.

The provided text is a 510(k) summary statement for the Monarch Nasal Implant. It states the intended use of the device and information about its materials, sterilization, and sizing. However, it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested table and study information based on the input text. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies.

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HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars

HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in managing would and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.

I am sorry, but the provided text does not contain information on acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device. The document is a 510(k) summary statement and a clearance letter for a medical device called "HANSON SCAR ADE," which is a silicone gel for scar management. It primarily focuses on the device's classification, intended use, and substantial equivalence to a predicate device (Kelo-Cote topical gel).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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The Hanson Medical Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Calf Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Hanson Medical Calf Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Calf Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part. liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.

Hanson Calf Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

The provided text is related to a 510(k) submission for the Hanson Medical Calf Implant. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and clinical efficacy data typically found for diagnostic AI devices.

Therefore, the information requested in your prompt (especially regarding acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance) is not present in the provided document. The document describes the device, its intended use, and its substantial equivalence to previously marketed devices, but does not detail a study proving its performance against specific acceptance criteria in the manner you've outlined for an AI-enabled device.

To directly answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence based on materials, manufacturing methods, and dimensions compared to predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of an AI performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-enabled device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-enabled device and no algorithm performance is mentioned.
7. The type of ground truth used: Not applicable. The "ground truth" here is the established safety and efficacy of the predicate devices.
8. The sample size for the training set: Not applicable. No training set for an AI model is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set for an AI model is mentioned.

Summary based on the document:

The Hanson Medical Calf Implant is presented as substantially equivalent to existing predicate devices (Hanson Medical Silicone Carving Block, AART, Inc and Silimed LLC Calf Implants). The basis for this equivalence is that it employs "the same materials, methods of manufacture, and are identical in dimension and very similar in others." The intended use is for augmentation or reconstruction to minimize muscular defects, and the device is carvable for customization. The regulatory review acknowledges the substantial equivalence to these predicate devices for the specified indications for use.

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The Hanson Medical Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery. The Hanson Gluteal Implant will be carvable, allowing the physician to customize the device shape for muscular defects.

Hanson Medical Gluteal Implants are intended for augmentation, or as reconstruction to minimize muscular defects. The Hanson Gluteal Implant is carvable, allowing the physician to adapt the device shape to individual patient contours. They are manufactured using heat cured, medical grade, two part, liquid silicone system (LSR), silicones that meet FDA requirements for replacement of Dow's discontinued medical grade silicone analogues.

Hanson Gluteal Implants will be offered non-sterile. The implants will be packaged in autoclavable peel pouches labeled with a detachable traceability tab for patient record files. Autoclave sterilization details are provided in the package insert. The implants are finally boxed with package insert materials and labeled for shelving and shipping traceability.

This document is a 510(k) summary statement for the Hanson Medical Gluteal Implant. It states that the device is substantially equivalent to previously marketed devices (Hanson Medical Silicone Carving Block, AART, Inc and Silimed LLC Gluteal Implants) based on similar materials, manufacturing methods, and dimensions.

However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory submission focused on demonstrating substantial equivalence, not on presenting performance data from a specific study.

Therefore, I cannot fulfill your request for an acceptance criteria table, study sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, or training set information because that information is not present in the provided text.

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The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile.

Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.

The provided text is a 510(k) summary for the Hanson Medical Pectoralis implant. It states that the device is substantially equivalent to a predicate device, meaning it's similar enough to an existing legally marketed device that it does not require significant new testing or data.

Therefore, this document does not describe acceptance criteria for device performance or a study proving the device meets said criteria. Instead, it focuses on demonstrating equivalence to an already approved device based on material composition, manufacturing processes, and intended use.

Here's an explanation of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence rather than establishing new performance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned for performance.
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. This device is a silicone implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a silicone implant.
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. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence based on material and intended use similarity, not a performance study with acceptance criteria.

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Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination.

Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .005 inch, nasal septal repair, tendon anastomosis, neural repair - . 007 inch. correction of strabismus .010 inch, repair - . 020 inch, orbital floor repair . 040inch, galea hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis . 007inch, repair of urethral strictures . 007inch, staged repair of omphalocoel .020inch, repair of orbital floor fractures .040inch.

Durasil I and Durasil II Silicone Elastomer Sheeting are made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone and Nusil Technologies' MED 4750. There is essentially no difference between these two products saving for the short term and long term indications which are for marketing considerations only. Durasil I and II are available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 607.

The provided text describes a 510(k) submission for Durasil Sheeting, which is a silicone elastomer product. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting evidence in the way a contemporary AI/Software as a Medical Device submission would.

Therefore, for aspects like "reported device performance," "sample size," "experts used," "adjudication method," "MRMC study," "standalone study," or "training set details," the information is not applicable in this context, as these are typically part of a clinical performance study for a new device's efficacy, not a substantial equivalence submission for a material.

Here's how to break down the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

• Materials meet or exceed Class VI USP Standards for biocompatibility (including Teratogenicity, Mutagenicity, Carcinogenicity, Toxicity Testing).
• Consistent with materials used in predicate device (Duralastic I and II). | - Made from HCRP-50 (Applied Silicone) and MED 4750 (Nusil Technologies), both biocompatible silicone high consistency rubbers.
• Materials meet FDA Biocompatibility Guidelines and exceed/meet Class VI USP Standards (Teratogenicity, Mutagenicity, Carcinogenicity, and Toxicity Testing). Referenced in Applied Master File - MAF 607 and Nusil Master File MAF 500.
• Chemically, Durasil II is dimethylpolysiloxane. |
  | Manufacturing Process | - Same manufacturing processes as predicate device. | - "Made from the same materials using the same processes" as predicate device. It is a "vulcanized calendared cured rubber." |
  | Physical Properties | - Consistent physical properties (hardness, elongation, tensile strength, tear strength, specific gravity) with predicate device. | - Hardness: 45-55 Durometer (Shore A).
• Elongation: 800 percent.
• Tensile Strength: 1600 psi.
• Tear Strength: 190 psi (Tear Die C).
• Elasticity: Greatly reduced in polyester reinforced sheets.
• Specific Gravity: 1.16.
• Details referenced in Masterfile MAF 607 (Applied Silicone) and MAF 500 (Nusil Technologies). |
  | Device Size and Thickness | - Same sizes and thicknesses as predicate device. | - "Made in the same sizes and thicknesses" as predicate device. Mentioned specific thicknesses in "Intended Uses" for Durasil II (e.g., .005 inch, .007 inch, .010 inch, .020 inch, .040 inch, .060 inch). |
  | Intended Use | - Same intended uses (short-term and long-term applications) as predicate device. | - Durasil I (Short Term): Nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, guided tissue regeneration between teeth and gingival margin, external ear canal, temporary joint spacers, and other short-term uses.
• Durasil II (Long Term):
  • Nonreinforced: Tympanic membrane repair, dural covering, nasal septal repair, tendon anastomosis, neural repair, correction of strabismus, orbital floor repair, galea hemodialysis shunt anchors.
  • Reinforced: Facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel, repair of orbital floor fractures. |
    | Sterilization | - Validated sterilization cycle. | - Sterilized via gamma radiation 2.5 - 4.2 Megarads.
• Validation by STI Corporation (Brea, CA) using Method 1 Testing as defined in ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization." |

Study Proving Device Meets Acceptance Criteria:

The primary "study" in a 510(k) submission for substantial equivalence is a comparison to a legally marketed predicate device.

• Substantial Equivalence Statement: The claim is that "These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses for the same intended use, it is SE to the predicate devices."

This is not a traditional scientific study with experimental results in the sense of a clinical trial. Instead, it's a demonstration that the new device (Durasil Sheeting) is as safe and effective as a device already on the market (Duralastic I and II) through direct comparison of materials, manufacturing, physical properties, dimensions, and intended uses.

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. This is a substantial equivalence submission based on material and design comparison, not a clinical performance test set. The "data" used is a direct comparison of specifications and intended use to the predicate 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 the context of device performance studies, is not established for this type of submission. The "truth" is established by the accepted specifications and performance of the predicate device.

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

• Not Applicable. No test set or adjudication method is described.

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 physical medical device (silicone sheeting), not an AI or imaging device that would involve human readers or AI assistance.

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

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

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

• Comparative Basis / Predicate Device Specifications: The "ground truth" for this submission is the established safety and efficacy, and the detailed specifications (material, physical properties, manufacturing process, intended use, sterilization validation) of the legally marketed predicate device (Duralastic I and II, K971480).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not Applicable. See point 8.

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Duralastic Nasal implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

To augment or reconstruct the nasal contour

Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562 and Nusil Technologies's MAF 612 for their MED 4211 Silicone Rubber -Unrestricted. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.

I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for Duralastic Nasal Implants from 1997, and it focuses on product description, substantial equivalence to a predicate device, intended use, physical/chemical properties, sterilization, and packaging. It also includes the FDA's clearance letter.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (clinical or otherwise) designed to prove the device meets acceptance criteria.
• Information on sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, as these are typically associated with performance evaluations of diagnostic or AI-driven devices, not simply material properties and substantial equivalence claims for an implantable medical device like this one.

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