(197 days)
The Mandibular Bone Distractor II is intended to be used in the treatment of conditions such as severe mandibular deficiency, post-surgical mandibular defects, or post-traumatic defects of the mandible. This device is intended to function as a stabilizer and mandibular lengthener. Bone transport procedures may also be performed. This device will allow linear and angular distraction of the mandible. The Mandibular Bone Distractor is intended for use in either adults or children.
The Mandibular Bone Distractor II is comprised of two arms, a central body which contains screws to adjust the angular relationship of the arms, and pin clamps. The pin clamps can accept 2mm or 3mm pins. All of the components of the Mandibular Bone Lengthener II are fabricated from stainless steel. The Mandibular Bone Distractor II is intended to be sold nonsterile. Sterilization instructions are included in the labeling.
This 510(k) summary for the Mandibular Bone Distractor II does not contain the level of detail necessary to answer all the questions regarding acceptance criteria and study data using the provided template. Medical devices like the Mandibular Bone Distractor II undergo various tests (e.g., mechanical, biocompatibility) to ensure safety and effectiveness, but the summary primarily focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting the results of detailed performance studies in the way you've outlined for AI/software-based devices.
Here's an attempt to answer based only on the provided text, highlighting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics with acceptance criteria for the Mandibular Bone Distractor II itself. Performance is inferred to be similar to the predicate devices.
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 and not provided. This section is typically relevant for studies involving data-driven devices like AI models, not for mechanical devices like a bone distractor, where performance is assessed through engineering testing (e.g., mechanical stress tests, biocompatibility assays) rather than analysis of a specific "test set" of clinical cases. The submission itself is for a mechanical device, and no clinical 'test set' in the context of data analysis is mentioned.
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 and not provided. The concept of "ground truth" established by experts for a test set of data is not relevant to the type of device described in this 510(k) summary. Performance validation for mechanical devices usually involves engineering tests and comparisons to established standards or predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. This is relevant to expert-based ground truth establishment for data-driven devices, not mechanical devices.
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 type of study is specifically for AI-assisted diagnostic or interpretative devices. The Mandibular Bone Distractor II is a physical medical device, not a software or AI tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is relevant for AI/software algorithms. The Mandibular Bone Distractor II is a physical device used by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable and not provided. The concept of "ground truth" in this context is mostly for diagnostic or prognostic systems. For a mechanical device, performance is typically validated against engineering specifications, material properties, and clinical outcomes (which are not detailed here but would be part of a broader clinical trial, not this 510(k) summary). The summary relies on "substantially equivalent" claims to predicate devices, inferring that if those devices were found safe and effective, this one, being similar, also is.
8. The sample size for the training set
Not applicable and not provided. As established, this is a mechanical device, not a data-driven AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable and not provided. Similar to the above, this concept doesn't apply to this type of device.
Summary of available information from the K960297 510(k) document:
The 510(k) submission for the Mandibular Bone Distractor II primarily relies on demonstrating substantial equivalence to previously cleared predicate devices. The arguments for equivalence are based on:
- Intended Use: Similar to existing external fixation devices for stabilization and distraction of bone, specifically in mandibular applications.
- Material: Uses stainless steel, which has a long history of successful clinical usage and is present in predicate devices.
- Design: Basic design features (pin clamps, connecting rods, screw mechanism) are similar to named predicate systems, with detailed comparisons for specific components.
- Operational Principles: The procedure for use (site preparation, pin placement, device construction, bone distraction) is similar to predicate devices.
Key takeaway: This 510(k) submission is for a traditional mechanical medical device, and therefore the criteria and study types typically associated with AI/software performance validation (e.g., test sets, training sets, ground truth establishment, MRMC studies) are not applicable. The "acceptance criteria" for a 510(k) are met by successfully demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective as the predicate.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.