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The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.

The provided text is a 510(k) summary for the "Mesh Fenestrated Introducer Needle." This document is part of the FDA regulatory process for medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving performance against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found within the provided text. The document describes the device's intended use and design, and states that its characteristics are substantially equivalent to predicate devices, but it does not include a performance study with acceptance criteria.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This type of information is typically found in a detailed performance study report. The 510(k) summary provided here does not contain such a table or specific performance results.
2. Sample sizes used for the test set and the data provenance: No performance study details are provided, so no sample sizes or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This relates to a performance study with a test set, which is not included in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, this refers to a performance study that is not detailed in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This type of study is specifically relevant to AI/diagnostic imaging devices. The device described (Mesh Introducer Needle) is a surgical instrument and not an AI-powered diagnostic device, so an MRMC study would not be applicable, and thus is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Similar to point 5, this is relevant to AI/algorithm-based devices, which this is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, no ground truth methodology is described.
8. The sample size for the training set: This is relevant for machine learning models, which are not part of this device.
9. How the ground truth for the training set was established: Again, this is relevant to machine learning models, which are not part of this device.

The 510(k) process for a device like the Mesh Introducer Needle primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) through comparisons of intended use, design, materials, and technological characteristics, as well as bench testing or sometimes limited clinical studies to ensure aspects like biocompatibility, sterility, and mechanical integrity. The provided text only covers the "substantial equivalence" argument, not a performance study against specific acceptance criteria.

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1. The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
2. The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components: The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter. The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion. In addition the system consists of accessory tools.

The provided text describes a 510(k) premarket notification for a medical device, the "Meta-Fix and Fixion FA Intramedullary Nailing Systems." This document is a regulatory submission for substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, device performance studies, or clinical trial details as typically found in a clinical study report or performance evaluation report.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on:

• Device Identification: Trade/Proprietary Names, Common Name, Classification Name, Product Code.
• Predicate Devices: Listing previously cleared devices to which the current device claims substantial equivalence.
• Intended Use: Specific clinical applications for the device.
• System Description: Brief overview of components and materials.
• Substantial Equivalence Claim: Stating that the new devices are substantially equivalent to predicate devices in intended use, design, materials, technological characteristics, and principles of operation.
• FDA Communication: The FDA's letter confirming the substantial equivalence determination and allowing the device to be marketed.

In summary, the provided text does not contain the information necessary to fulfill your request regarding acceptance criteria and performance study details.

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The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebrai compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence Fenestrated Introducer Needle, a part of the Confidence Cement Delivery System, is combined of a cannula and a stylet. The cannula has a diamond-shape closed distal tip, and has numerous holes located around its distal section.

This document, K063067, is a 510(k) Summary for the Confidence Fenestrated Introducer Needle, a component of the Confidence Bone Cement Delivery System. This submission is for a medical device, not an AI/ML powered device, therefore the information requested cannot be fully extracted.

Here's a breakdown of what can be inferred and what cannot based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Not applicable: This document describes a physical medical device (an introducer needle) and not an AI/ML system. Therefore, there are no "acceptance criteria" or "reported device performance" in terms of algorithmic metrics (like accuracy, sensitivity, specificity) that would be relevant to an AI/ML device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, technological characteristics, and principles of operation.

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

• Not applicable: No test set in the context of AI/ML validation is mentioned. This is a physical device.

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 adjudication method 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: No MRMC study is mentioned. This is a physical device, not an AI system designed to assist human readers.

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

• Not applicable: No standalone algorithm performance is mentioned.

7. The type of ground truth used

• Not applicable: As this is a physical device, the concept of "ground truth" as it applies to AI/ML model training or validation does not apply. The validation for this type of device typically involves demonstrating manufacturing and functional equivalence to a predicate device, as well as adherence to relevant standards, not a comparison against expert-labeled data.

8. The sample size for the training set

• Not applicable: No training set is mentioned as this is a physical medical device, not an AI/ML product.

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

• Not applicable: No training set or associated ground truth is mentioned.

Summary of available information:

• Device Name: Confidence Fenestrated Introducer Needle
• Intended Use: For percutaneous delivery of bone cement during vertebroplasty/kyphoplasty procedures.
• Predicate Devices: Confidence High Viscosity Bone Cements (K060300, K062424)
• Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation to the predicate device.

To reiterate, the provided document pertains to the regulatory clearance of a physical medical instrument and does not contain the kind of information relevant to the validation of an AI/ML powered medical device.

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The Disc-O-Tech Confidence EX High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence EX High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (22.5 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

The provided text is a 510(k) summary for a medical device (bone cement), and it does not contain information typically found in a study proving a device meets acceptance criteria for an AI/software as a medical device (SaMD) product. The document focuses on establishing substantial equivalence for the bone cement itself, primarily based on material properties and intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as these concepts are not applicable to the content of this 510(k) summary. These details would be relevant for a software-based device that performs a diagnostic or prognostic function, not for a PMMA bone cement.

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The Disc-O-Tech Confidence High Viscosity Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

The Confidence High Viscosity Bone Cement is a radiopaque, self-curing, high viscosity PMMA bone cement. It is provided sterile, as a two-component system (20 g powder (polymer) and 9.2 g liquid (monomer)), which are mixed prior to use to form the cement. The powder component contains 30.07 % barium sulfate.

This document, a 510(k) summary for the "Confidence High Viscosity Bone Cement," describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) process is primarily a demonstration of "substantial equivalence" to a legally marketed predicate device, not typically a full clinical efficacy or performance study against predefined acceptance criteria in the way a PMA (Premarket Approval) might require.

Therefore, I cannot populate the requested table and answer many of your questions based solely on the provided text.

Here's a breakdown of why and what I can or cannot answer:

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

• No information in the provided text. The document describes the device's composition, intended use, and states its substantial equivalence to predicate devices based on various characteristics, but it does not specify quantitative acceptance criteria (e.g., "tensile strength must be > X MPa") or report specific performance data against such criteria.

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

• No information in the provided text. This document is a regulatory submission for substantial equivalence, not a detailed study report. It does not mention any test set, sample sizes, or data provenance from a specific study.

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/No information in the provided text. Ground truth is typically relevant for studies evaluating diagnostic accuracy, machine learning algorithms, or clinical outcomes. This document does not describe such a study.

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

• Not applicable/No information in the provided text. Same as above.

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/No information in the provided text. This device is a bone cement, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to its regulatory submission as described here.

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

• Not applicable/No information in the provided text. This device is a physical product (bone cement), not an algorithm.

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

• Not applicable/No information in the provided text. See points 3 and 4.

8. The sample size for the training set

• Not applicable/No information in the provided text. This device is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable/No information in the provided text. See point 8.

Summary of what the document does provide:

• Device Name: Confidence High Viscosity Bone Cement
• Applicant: Disc-O-Tech Medical Technologies Ltd.
• Date Prepared: January 2006
• Classification: Class II, PMMA Bone Cement (For Vertebroplasty), 21 CFR §888.3027
• Predicate Devices:
  • Kyphon Inc.'s KyphX® HV-RTM Bone Cement (K041584)
  • Stryker Corp.'s Spineplex™ Radiopaque Bone Cement (K032945)
  • Cook Inc.'s Vertefix™ Radiopaque Bone Cement (K042691)
• Intended Use: For the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures, for painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
• System Description: Radiopaque, self-curing, high viscosity PMMA bone cement, two-component system (powder + liquid), contains 30.07% barium sulfate.
• Basis for Substantial Equivalence: Intended use, chemical composition, material properties, biocompatibility, principles of operation, technological characteristics, performance, and clinical application are substantially equivalent to predicate devices.

Conclusion:

The provided text serves as a 510(k) summary, demonstrating "substantial equivalence" of the new device to existing predicate devices. It focuses on comparing characteristics and intended use, rather than presenting a performance study against specific acceptance criteria. Therefore, the detailed information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth validation that you've requested is not present in this type of regulatory document.

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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine; hand, tibia; radius and calcaneus. In the spine, it may be used in combination with polymethylmethacrylate (PMMA) bone cernents that are legally marketed for use in vertebroplasty or kyphoplasty procedures.

The SKy System consists of the following components:

• Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
• Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set - a set of accessories to assist in insertion and location of the device.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the SKy Bone Expander System, outlining its intended use, description, and substantial equivalence to previously cleared devices. It does not include details about performance testing, sample sizes, ground truth establishment, or clinical studies.

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The SKy Bone Expander System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components:

• Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced diameter configuration and expanded within the bone.
• Delivery System used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set a set of accessories to assist in insertion and location of the device.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. SKy Bone Expander System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and the study proving the device meets them, as that information is not present in the given input.

The document discusses:

• Company and Product Information: Name, contact, date prepared, trade/proprietary name, classification.
• Predicate Devices: Lists similar devices.
• Intended Use: Specifies the medical application of the device.
• System Description: Describes the components of the SKy System.
• Substantial Equivalence: Highlights similarities between the modified SKy System and its previously cleared version, and other predicate devices, focusing on operating principles, design, materials, packaging, and sterilization.
• FDA Correspondence: Official letter from the FDA confirming the substantial equivalence determination and allowing the device to be marketed.
• Indications for Use Form: A standard form reiterating the intended use.

None of these sections include data from performance studies, acceptance criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods typically found in effectiveness or validation studies.

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The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of:

• Femoral head and/or neck fractures or non-unions.
• Aseptic necrosis of the femoral head and/or neck.
• Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement.

The Fixion® Hip System is indicated as a total hip replacement in cases of:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The Fixion® Hip Stem is intended for cemented or non-cemented use.

The Fixion® Hip System is composed of an implant, inflation device (pump) and an instrumentation set.

• Implant comprises femoral stem and head ball, and for total hip replacement - acetabular cup and liner and cancellous bone screws, as detailed below:
  • A stainless steel Stem, including stem body and neck, which is inserted into the femoral medullary canal and expanded following insertion.
  • A Head Ball, assembled on the stem neck and articulates within the acetabulum (in hemi-hip replacement) or acetabular cup and liner (in total hip replacement). A unipolar stainless steel head (for hemi- hip replacement), and a cobalt chromium head (for total hip replacement) are available.
  • A porous coated, cobalt chromium Acetabular Cup, inserted and fixated within the acetabulum.
  • A UHMWPE Acetabular Cup Liner, which is seated inside the acetabular cup.
  • Cobalt chromium Cancellous Bone Screws, intended to fixate the acetabular cup to the acetabulum, in cases additional stabilization of the cup is required.
• Instrumentation Set - a set of accessories to be used with the Fixion® Hip implants.
• Inflation Device (Pump) - a manual pump used to expand the Fixion® stem.

The provided text describes the 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. Fixion® Hip System, which is a medical device application. Medical device regulatory submissions like 510(k) summaries do not typically include the detailed study design elements you are asking for, such as specific acceptance criteria and detailed performance reporting from a clinical study, sample sizes for test and training sets, ground truth establishment methods, or multi-reader multi-case (MRMC) study results with effect sizes.

Instead, 510(k) submissions demonstrate "substantial equivalence" to legally marketed predicate devices. This is typically achieved through:

• Comparison of technological characteristics: Showing that the new device has the same intended use, design features, materials, and operating principles as one or more predicate devices.
• Performance testing (benchtop/mechanical): Ensuring the device meets relevant industry consensus standards (e.g., ISO, ASTM) to demonstrate safety and effectiveness for its intended use, often through engineering tests rather than clinical trials with human subjects.
• Biocompatibility testing: As required.

The document states: "The Fixion® Hip System intended use, design, materials, technological characteristics and principles of operation are substantially equivalent to those of Disc-O-Tech's Fixion® Unipolar Modular Hemi-Hip System (K014072, K030972), Fixion® Interlocking PF Intramedullary Nailing System (K010988, K012967, K023437), United Orthopedic Corporation' U1 Hip System (K994078 Orthopaedics' Elite® Modular Hip System (K871867) and S-ROM® Total Hip System (K851422, K913231, K954935, K961939 and others), and the Link America Inc.' Link® MP® Hip System (K955296)."

It also lists several Performance Standards (ISO and ASTM) that were referred to. These standards define the mechanical and material properties that such an implant should meet. Meeting these standards comprises the "acceptance criteria" for the mechanical performance of the device.

Therefore, I cannot provide the specific details you requested because they are not typically part of a 510(k) summary for a hip implant system, which focuses on substantial equivalence rather than a clinical study demonstrating performance against a detailed set of acceptance criteria with human subjects or AI algorithms.

However, I can extract the closest analogous information from the document regarding acceptance criteria and performance:

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

Note: The "reported device performance" is inferred from the statement of "substantial equivalence" and the reference to these standards. Regulatory bodies accept that if a device design, materials, and mechanical properties meet these established standards, it is inherently performing acceptably for its intended use, similar to predicate devices that have also met these standards.

The following information cannot be extracted from the provided text for the reasons explained above, as this document is a 510(k) summary focused on substantial equivalence rather than a clinical trial report:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The SKy System is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.

The SKy System consists of the following components:

• √ Expandable Tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.

• Delivery System used for the insertion, expansion, and retrieval of the expandable tube.

• V Instrumentation Set a set of accessories to assist in insertion and location of the device.

This 510(k) summary (K034037) for the SKy Bone Expander System primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information regarding acceptance criteria, performance studies, or quantitative results often found in submissions for novel or higher-risk devices.

Therefore, many of the requested sections cannot be fully populated from the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or a reported device performance table. The submission is a 510(k) seeking substantial equivalence, which implies that the device's performance is expected to be "as safe and effective as, and performs as well as or better than" the predicate devices. Performance is likely demonstrated through substantial equivalence arguments and engineering testing rather than a clinical study with stated acceptance criteria.

Study Information

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

• Acceptance Criteria: Not explicitly stated in the provided text. For a 510(k) based on substantial equivalence, acceptance criteria would typically relate to mechanical performance, biocompatibility, sterilization, and sometimes clinical equivalence to predicate devices.
• Reported Device Performance: Not explicitly reported in a quantitative table within the provided text. The document states similarities to the predicate device in terms of intended use, operating principles, design principles, materials, packaging, and sterilization methods.

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

• The provided text does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing the new device to previously cleared predicate devices.
• Data Provenance: Not applicable in the context of a clinical test set in this document. The manufacturer is Disc-O-Tech Medical Technologies Ltd., based in Herzliya, Israel.

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. The document does not describe a clinical study requiring ground truth establishment by experts.

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

• Not applicable. The document does not describe a clinical study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. The device (SKy Bone Expander System) is a physical surgical implant/instrument, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable. The device is a physical surgical implant/instrument, not an algorithm.

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

• Not applicable. The document does not describe a study involving ground truth in a clinical context. Substantial equivalence for this type of device is typically demonstrated through engineering testing (e.g., mechanical strength, fatigue), biocompatibility testing, and comparison of design features and materials to predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of available information regarding the device and its clearance:

• Device Name: SKy Bone Expander System (SKy System)
• Applicant: Disc-O-Tech Medical Technologies, Ltd. (Israel)
• Date Prepared: December 2003
• Classification: Class II
• Predicate Devices:
  • B-Twin Bone Expander System (K032358), by Disc-O-Tech Medical Technologies Ltd.
  • KyphX Inflatable Bone Tamp (K981251, K010246, K032212), by Kyphon Inc.
• Intended Use: As a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius and calcaneus.
• System Description: Consists of an Expandable Tube, Delivery System, and Instrumentation Set.
• Substantial Equivalence Argument: Based on having the same intended use, operating principles, design principles, similar/same materials, same packaging, and same/equivalent sterilization method as the B-Twin BE System predicate.
• FDA Determination: FDA found the device substantially equivalent (K034037) to legally marketed predicate devices, allowing it to proceed to market under general controls.

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The B-Twin Bone Expander System (B-Twin BE System) is intended for use as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus.

The B-Twin BE System consists of the following components:

• Expandable tube a tube-like component, mounted on a delivery system. Inserted into the bone in reduced 5-mm diameter configuration and expanded within the bone.
• Delivery system used for the insertion, expansion, and retrieval of the expandable tube.
• Instrumentation Set a set of accessories to assist in insertion and location of the device.

This 510(k) premarket notification for the B-Twin Bone Expander System focuses on substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a De Novo submission or a more comprehensive PMA. Therefore, most of the requested information regarding specific acceptance criteria, performance tables, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from the provided text.

Here's what can be inferred or explicitly stated from the document:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in a quantitative or qualitative manner, nor does it provide a table of reported device performance against such criteria. The submission is based on the claim of substantial equivalence to predicate devices. This means the device is deemed acceptable if it is as safe and effective as a legally marketed device and shares similar technological characteristics and intended use.

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

• Sample size for the test set: Not provided. The submission focuses on claims of substantial equivalence rather than a new clinical study with a test set.
• Data provenance: Not provided.

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 to this type of submission, as a "test set" and "ground truth" as typically defined in performance studies for diagnostic devices are not described. The basis for approval is substantial equivalence to existing devices.

4. Adjudication method for the test set:

Not applicable for the reasons mentioned above.

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. The B-Twin Bone Expander System is a physical medical device (bone tamp), not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant.

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

Not applicable. The B-Twin Bone Expander System is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable. The approval is based on substantial equivalence to predicate devices, not on proving effectiveness against a specific ground truth in a clinical trial setting detailed in this document.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI models that require a training set.

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

Not applicable for the same reasons as above.

Summary of available information related to equivalence:

The submission focuses on demonstrating "substantial equivalence" of the B-Twin Bone Expander System to currently marketed predicate devices.

• Predicate Devices:

  • KyphX Inflatable Bone Tamp (K981251, K010246) by Kyphon Inc.
  • Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967, K023437) by Disc-O-Tech Medical Technologies, Ltd.

• Basis for Substantial Equivalence:

  • Intended use
  • Design
  • Material
  • Technological characteristics
  • Principles of operation

• Specific Equivalence Claims:

  • "In general, the B-Twin BE System intended use, design, material, technological characteristics and principles of operation are substantially equivalent to those of Kyphon's KyphX Inflatable Bone Tamp (K981251, K010246)."
  • "In addition, with respect to certain issues like sterilization, equivalence is claimed to the different Fixion Intramedullary Nailing Systems (e.g., the Fixion PF - K010988, K012967, K023437)."
  • "Expandable Tube material equivalence is claimed to polymeric tubes for medical applications."

In essence, the "study" proving the device meets "acceptance criteria" in this context is the comparison against the predicate devices for substantial equivalence, as documented in the 510(k) submission itself. The FDA's decision letter (K032358) confirms that, based on the submitted information, the device was determined to be substantially equivalent.

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