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510(k) Data Aggregation
(257 days)
The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.
The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.
This document describes the aap Cannulated Headless Bone Screws, a medical device for bone fixation. Since this is a 510(k) summary, the core of the submission is to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing brand-new performance criteria for a novel device. Therefore, the "acceptance criteria" here are largely defined by demonstrating that the new device performs at least as well as and shares similar characteristics with the predicate devices.
Here's an analysis of the provided information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit acceptance criteria with numerical targets as one might see for a novel device, the "acceptance criteria" here are met by demonstrating similarity and comparable performance to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated in the submission) |
|---|---|
| Intended Use: The device must have the same or similar intended use as the predicate devices. | The aap Cannulated Headless Bone Screws have the same intended use as the primary predicate K111316 and reference devices K130590 and K131459, and similar technological characteristics for bone fracture fixation (bone screws and K-Wire). |
| Technological Characteristics: The device must have similar technological characteristics (e.g., design, materials, operating principles) as the predicate devices. | The subject device bone screws have similar ranges of thread diameters, threaded lengths, and screw designs to the primary predicate K111316 and reference device K130590. The K-Wire dimensions are within the range of K-Wires cleared in K131459. |
| Material Composition: The device materials must be identical or equivalent to those of the predicate devices. | The screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3, using materials and processes identical to predicate devices. The K-Wire is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1, also using processes identical to predicate devices. |
| Biocompatibility: The device must be biocompatible, demonstrated by using identical/equivalent materials and manufacturing processes as predicate devices. | Biocompatibility for the subject device materials was referenced from K111316, K130590, and K131459, indicating identical materials and processes as previously cleared devices. |
| Sterilization: The device must be able to be sterilized to a sterility assurance level (SAL). | The devices are provided non-sterile and are to be sterilized to a SAL of 10-6 by the end user using the same sterilization method (moist heat) and parameters as previously cleared devices. Analysis showed the subject devices do not create a new worst case for moist heat sterilization. |
| Mechanical Performance: The device must meet recognized industry standards for mechanical performance. | Mechanical testing of the subject device screws was performed according to ASTM F543. While specific quantitative results aren't provided in this summary, the implication is that they meet the standard to support substantial equivalence. |
| Packaging and Shelf Life: The device packaging and shelf-life characteristics must be consistent with predicate devices. | Packaging and shelf life information for the subject devices was referenced from K111316, K130590, and K131459. |
| Manufacturing Process: The device must be manufactured using identical or similar processes as predicate devices. | All subject device final finished components are manufactured in the same facilities using identical manufacturing processes as used for previously cleared aap device components. |
| Pediatric Population Use Support: The device's use in pediatric populations must be supported by comparison to predicate devices. | Reference device K161616 is used to support the use of the subject screws in the pediatric population. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or clinical cases for this submission's testing. The non-clinical performance data mentions "mechanical testing of the subject device screws according to ASTM F543." ASTM F543 outlines test methods, but the specific number of screws tested is not provided in this summary.
- Data Provenance: The data is primarily non-clinical performance data which includes mechanical testing, sterilization validation, and references to previous submissions (K111316, K130590, K131459, K161616) for biocompatibility, packaging, and shelf-life. There is no clinical data included in this submission. The origin of the reference data for predicate devices is not specified, but previous 510(k) submissions would have their own established provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not on establishing ground truth via expert review of clinical cases.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There's no test set requiring human adjudication for diagnostic or interpretive tasks. The evaluation is based on engineering specifications, material standards, and mechanical test results.
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 medical device (bone screws and K-wires), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
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 or software.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications and Material Standards: Compliance with recognized standards like ASTM F136, ISO 5832-3, ASTM F138, ISO 5832-1, ASTM F543, ISO 17665-1, ISO 10993-1. These standards define the acceptable properties and performance for such devices.
- Bench Testing: Mechanical testing data according to ASTM F543.
- Referencing Predicate Devices: The established regulatory clearances and performance data of the cited predicate devices (K111316, K130590, K131459, K161616) serve as a de-facto "ground truth" for comparison under the substantial equivalence pathway.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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