(140 days)
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.
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Predicate Devices:
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Basis for Substantial Equivalence:
- Intended use
- Design
- Material
- Technological characteristics
- Principles of operation
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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.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.