(85 days)
The Telescopic Distractor is an intraoral, subcutaneous distractor which is used for mandibular distraction osteogenesis. The device is indicated for use in patients with congenital micrognathia, post-traumatic mandibular deformities, or defects resulting from tumor resection. In conjunction with osteotomy or corticotomy, the Telescopic Distractor may be used for:
- mandibular body lengthening; .
- mandibular ramus lengthening;
- distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis; and
- transport distraction osteogenesis across a mandibular segmental . defect in the ramus, body, or symphysis.
Innova Corporation requests marketing clearance for the Telescopic Distractor, an intraoral subcutaneous device that permits either unilateral lengthening of the mandible. The device consists of forward and rear telescoping bodies that are held together by a central element. The subject device is designed with a central element that can be moved in opposing directions by turning an adjustment screw, producing the telescopic action. The telescoping bodies are attached to the inferior border of the mandibular osteotomy with bone plates and screws. The telescopic elements slide freely in the central element. The maximum amount of distraction possible between the two sections is 18 millimeters. A circular pin and a separate adjustment screw attaches the forward telescoping element to the forward bone plate. The circular pin provides a rigid, interlocking connection because of the snug fit within the opening in the forward telescoping element. The forward bone plate can be moved transversely relative to the telescopic elements by the adjustment screw. The rear telescopic element is similarly connected to the rear bone plate. The forward and rear bone plate elements are secured to the mandible with four bicortical stainless steel bone screws. Following placement of the distractor, the clinician waits for a period of 5 to 10 days to allow for intraoral healing prior to initiating distraction. The Innova Telescoping Distractor is made from wrought surgical grade stainless steel. The material conforms to ASTM F 138-97. This material is currently used in a variety of implanted devices such as bone plates and has a demonstrated biocompatibility by its long history of use for implant applications. The Telescoping Distractor is available in two models; unilateral and bilateral. The devices are operated and applied in an identical manner, except that the unilateral model is intended for distraction osteogenesis of either the right or the left side of the mandible. while the bilateral model is intended to be used for simultaneous distraction osteogenesis of both the right and left sides of the mandible.
The provided text is a 510(k) premarket notification for the Innova Telescopic Distractor. This type of FDA submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with acceptance criteria.
Therefore, the document does not report acceptance criteria or a study designed to prove the device meets such criteria in the way a clinical trial would. Instead, it focuses on comparing the new device to an existing, cleared device.
However, I can extract information related to the device's technical characteristics and intended use, which inherently imply certain performance expectations, and describe the comparison methodology used.
Here's a breakdown based on your request, adapted to the nature of a 510(k) submission:
Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence Claim)
Since this is a 510(k) submission, there aren't explicit "acceptance criteria" in the sense of predefined thresholds for a study to demonstrate safety and effectiveness. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The "device performance" reported is largely a description of its features and how they align with the predicate.
| Characteristic/Performance Aspect | Innova Telescopic Distractor (Subject Device) | Predicate Device (Howmedica Mandibular Distractor II, K960297) | Implied "Acceptance" (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Mandibular distraction osteogenesis | Mandibular distraction osteogenesis | Met: Both devices are intended for the same clinical purpose (mandibular lengthening). |
| Principle of Operation | Intraoral subcutaneous device; forward & rear telescoping bodies with adjustment screw | Stabilizer and bone lengthener through distraction of the mandible | Met: Both operate on the principle of distraction osteogenesis to lengthen the mandible. |
| Maximum Distraction | Up to 18 mm | Not explicitly stated in the provided text for predicate, but implied similar mechanism | Met: The mechanism allows for bone lengthening, with the subject device offering up to 18mm. |
| Patient Population | Adult, adolescent, or pediatric patients | Adults and children | Met: Both are indicated for a broad age range. |
| Device Material | Wrought surgical grade stainless steel (ASTM F 138-97) | Not explicitly stated in the provided text for predicate | Met: Use of a biocompatible and established surgical material. The text states the material "is currently used in a variety of implanted devices" and has "demonstrated biocompatibility by its long history of use for implant applications." |
| Sterilization | Supplied non-sterile; sterilization instructions included; single-use only | Supplied non-sterile; single-use only | Met: Both follow the same non-sterile supply and single-use sterilization protocol. |
| Models Available | Unilateral and Bilateral | Not explicitly stated in the provided text for predicate | Met: The availability of options addresses different clinical needs, aligning with the functional scope of distraction devices. |
| Indications for Specific Procedures | Mandibular body lengthening, ramus lengthening, distraction across segmental defect, transport distraction osteogenesis | Same general indications as the subject device (mandibular lengthening, stabilization) | Met: Both cover similar specific applications within the broader mandibular distraction osteogenesis. |
| Overall Technological Characteristics | Intraoral subcutaneous device, telescoping bodies, adjustment screw, bone plates/screws for attachment | Intraoral device, similar principle of operation for distraction | Met: The submission explicitly states "The devices share similar technological characteristics," focusing on the intraoral, subcutaneous nature and the distraction mechanism. |
Study Information (Relevant to a 510(k) Submission)
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Sample size used for the test set and the data provenance:
- No "test set" in the traditional sense. A 510(k) notification primarily relies on design and performance characteristics comparison to a predicate device, rather than a prospective clinical study with a "test set" of patients. The "data" used is the description and specifications of both the subject device and the predicate device.
- Data Provenance: The 'data' for the subject device comes from the manufacturer's own design specifications, material selections, and labeling. The 'data' for the predicate device (Howmedica Mandibular Distractor II, K960297) would come from its own 510(k) clearance documentation and publicly available information. This is retrospective in the sense that it relies on existing device data and clearances.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" with ground truth established by experts in a clinical study context. The "ground truth" for a 510(k) is the regulatory finding of "substantial equivalence" by the FDA. The experts involved are the FDA reviewers (e.g., Sandra L. Shire, DMD, MP, Dental Officer), whose qualifications are implied by their roles within the FDA.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set and thus no adjudication method for ground truth. The "adjudication" is the FDA's regulatory review process itself, culminating in the "substantially equivalent" determination.
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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:
- No MRMC study was done. This device is a mechanical surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, the concept of "human readers improve with AI" is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical "ground truth." As discussed, the "ground truth" in a 510(k) is the FDA's determination of substantial equivalence, based on a comparison of device characteristics, intended use, and technological principles.
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The sample size for the training set:
- Not applicable. There is no "training set" for an algorithm, as this is a mechanical device.
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How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm.
§ 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.