(30 days)
InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The InFill™ intervertebral body fusion device is a radiolucent implantable device The in in in - fine PEEK and tantalum (marker material). The implant is available in manatatored 110 11011 * 11011 * 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
The InFill™ intervertebral body fusion device is provided sterile, for single use only.
The provided text is a 510(k) summary for the InFill™ Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device for a minor modification rather than presenting a novel device with extensive new performance data. Therefore, the information required for a detailed acceptance criteria and study description, especially for AI/ML devices, is largely absent.
Here's an analysis based on the provided text, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical/Biological Integrity (Implicitly assumed for intervertebral body fusion devices, but not explicitly stated as acceptance criteria in the document for the modified device's 510(k) Summary) | "The modified InFill™ intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions." |
| Substantial Equivalence to Predicate Device (K103729) | "The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill™ intervertebral body fusion device is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill™ intervertebral body fusion device (K103729)." |
| Safety and Effectiveness (General) | "All testing was performed on test units representative of finished devices." (Implied to demonstrate safety and effectiveness, but no specific metrics or targets are given.) |
Explanation: The document does not specify quantified acceptance criteria (e.g., "tensile strength must be >X MPa" or "fatigue life >Y cycles"). Instead, it broadly states that "all specified criteria" were met, implying that the device was tested against established standards for intervertebral body fusion devices, and it performed comparably to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
- The document implies that "testing was performed on test units representative of finished devices," but states no specific sample sizes for mechanical, material, or other performance tests.
- The provenance of any data (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document.
- This device is a physical intervertebral body fusion device, not an AI/ML diagnostic or therapeutic device that would typically involve expert-established ground truth from a test set of medical images or patient data.
- The evaluation is focused on the device's physical and material properties, and its substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document.
- Similar to point 3, adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation or AI model performance on qualitative data. This device's evaluation does not involve such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided in the document.
- MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This submission is for a physical medical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document.
- Standalone performance studies are for AI algorithms. This is an implant.
7. The Type of Ground Truth Used
This information is not applicable in the context of typical AI/ML ground truth (expert consensus, pathology, outcomes data).
- For this device, the "ground truth" for its performance would be engineering specifications, material properties, biomechanical test standards, and successful performance against those standards and comparison to the predicate device. The document generally states "met all specified criteria."
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document.
- There is no AI/ML algorithm involved in this device submission, therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document.
- As there is no training set for an AI/ML algorithm, this question is irrelevant to this submission.
Summary of the Study (Based on the document):
The study described is not a clinical trial or an AI/ML performance study. It is a design verification and validation process for a minor modification to an already cleared intervertebral body fusion device. The "study" aims to demonstrate substantial equivalence to the predicate device (InFill™ Intervertebral Body Fusion Device, K103729).
- Objective: To verify that the modified InFill™ Intervertebral Body Fusion Device performs as intended and introduces no new safety or performance concerns, making it substantially equivalent to the predicate device.
- Methodology: "Performance Data: All testing was performed on test units representative of finished devices." The document implies that this testing included evaluations of the device's material properties, mechanical strength, and other relevant characteristics for an intervertebral body fusion device, against predetermined engineering specifications and industry standards.
- Proof: The key "proof" of meeting acceptance criteria is the statement: "The modified InFill™ intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions." This, coupled with the assertion that "The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device," forms the basis for the FDA's determination of substantial equivalence.
In essence, the "study" is a comparison of the modified device's characteristics and performance to existing requirements and the predicate device, rather than a novel investigation with detailed clinical or AI performance metrics.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.