(89 days)
The INDEPENDENCE™ Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The INDEPENDENCE™ Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws which accompany the implant.
The INDEPENDENCE™ Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The INDEPENDENCE™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.
The provided text describes the INDEPENDENCE™ Spacer, an intervertebral body fusion device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.
The document is a 510(k) summary and an FDA clearance letter, which focus on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The response in the table below reflects the absence of this information in the provided document.
Acceptance Criteria and Device Performance Study Information
The provided document describes the INDEPENDENCE™ Spacer and its FDA 510(k) clearance based on substantial equivalence to predicate devices. However, the document does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies (e.g., sample sizes, ground truth establishment, expert involvement, adjudication) that would typically accompany a clinical or performance study demonstrating that the device meets defined acceptance criteria.
The basis for substantial equivalence is stated as compliance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. This guidance document would outline the types of tests and considerations for performance, but the results of such tests against specific quantitative acceptance criteria are not presented in this 510(k) summary.
Therefore, the following table and subsequent sections will reflect the absence of this detailed performance study information in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|
| No specific quantitative acceptance criteria are provided in the document. | No specific quantitative device performance results are provided in the document. |
| The device was evaluated in accordance with the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007. | Found to meet the criteria set forth in the guidance document in terms of indications, design, and performance, leading to substantial equivalence determination. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text. The document refers to evaluation against a guidance document, implying a regulatory review process, but not a specific clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not mentioned in the provided text.
4. Adjudication method for the test set
- This information is not mentioned in the provided text.
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
- This information is not applicable and not mentioned in the provided text. The device is a physical interbody fusion spacer, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not mentioned in the provided text. The device is a physical interbody fusion spacer.
7. The type of ground truth used
- This information is not mentioned in the provided text.
8. The sample size for the training set
- This information is not mentioned in the provided text.
9. How the ground truth for the training set was established
- This information is not mentioned in the provided text.
§ 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.