(115 days)
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
The AccuLIF TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). As with the predicate expandable AccuLIF TL and PL Cage devices, the device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.
This document is a 510(k) summary for a medical device called AccuLIF® TL and PL Cage. It informs the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device. The document does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving clinical performance against specific metrics.
Here's a breakdown of why the requested information about acceptance criteria and a study proving performance isn't fully applicable or available in this type of document, but how some related information can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" are typically related to demonstrating that the new device is as safe and effective as a predicate device. This is often achieved through comparison of technological characteristics and performance data (bench testing, not clinical performance for this type of device). Specific numerical acceptance criteria for a "device performance" in terms of clinical accuracy (like sensitivity/specificity) are not typically defined or presented in a 510(k) for an intervertebral body fusion device.
- Reported Device Performance: The document states: "Design verification testing was conducted to assess the device modification. The non-clinical test results demonstrate that the modified device is substantially equivalent to the predicate." This implies that the performance in non-clinical (bench) tests met the criteria for substantial equivalence to the predicate, likely in mechanical properties, material properties, and functionality of the expansion mechanism. Specific numerical results are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This is a medical implant (intervertebral fusion device), not an AI/ML diagnostic or prognostic tool. Therefore, there isn't a "test set" of patient data in the typical sense for evaluating algorithm performance.
- The testing mentioned ("Design verification testing") refers to bench testing (e.g., mechanical strength, material compatibility, functionality). The sample sizes for these types of tests would be determined by engineering and statistical requirements for mechanical testing, not by patient data.
- Data provenance for such tests would be related to the lab where the tests were conducted, not patient demographics or origin.
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. There is no "ground truth" to be established by medical experts for the performance of this device in the context of this 510(k) submission. The "performance" being evaluated is the physical and mechanical characteristics of the implant and its accessories.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as there is no expert review or adjudication of a test set of clinical data.
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 not an AI/ML device, and therefore, no MRMC study would be conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable, as this is not an algorithm or AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of clinical "ground truth." The "truth" for this device's performance would be against engineering specifications, material standards (ASTM F136-08, ASTM F138-08), and functional requirements tested through design verification.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, 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" or a ground truth established in this context.
In summary, the provided document is a 510(k) clearance letter for an intervertebral body fusion device. It demonstrates substantial equivalence to a predicate device primarily through non-clinical (bench) testing of its physical properties and functionality. This type of submission does not typically involve the kinds of clinical performance studies, datasets, expert reviews, or AI/ML specific evaluations that your questions are designed to uncover.
§ 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.