(167 days)
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ESL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time.
As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.
The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
The provided 510(k) summary for the Biomet Spine ESL® Spinal System does not contain information on a study proving the device meets specific acceptance criteria in the manner typically seen for AI/ML-based devices or studies requiring performance metrics like sensitivity, specificity, or various accuracy measures.
Instead, this submission is focused on demonstrating substantial equivalence to predicate devices for a physical medical implant (intervertebral fusion device). The "study" here refers to the comparisons made to existing devices and mechanical testing, rather than a clinical performance study with specific quantitative acceptance criteria of AI/ML algorithms.
Here's a breakdown based on the provided text, addressing the points where information is available and noting where it is not applicable or not provided:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The ESL® Spinal System is a physical medical device designed for spinal applications. Its acceptance for market clearance via a 510(k) submission is based on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific performance thresholds derived from a clinical study comparing AI outputs to ground truth.
The "study" that proves the device meets acceptance criteria primarily involves:
- Comparison of technological characteristics (material, design, sizing, intended use, indications, principles of operation) to predicate devices.
- Mechanical testing to ensure the device's performance is equivalent to, or better than, predicate devices for its intended use, particularly for restoring biomechanical integrity.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate devices) | Reported Device Performance (Summary from text) |
|---|---|---|
| Intended Use | Must be similar to predicate devices. | "Substantially equivalent to its predicate devices with respect to intended use and indications." |
| Indications for Use | Must be similar to predicate devices. | "Substantially equivalent to its predicate devices with respect to intended use and indications." |
| Technological Characteristics | Material, design, and sizing must be the same as, or similar to, predicate devices. | "The technological characteristics (material, design and sizing) of the ESL® Spinal Spacer is the same as, or similar to, the predicate devices." |
| Principles of Operation | Must be similar to predicate devices. | "Substantially equivalent to its predicate devices with respect to ... principles of operation." |
| Safety and Effectiveness | Must not present any new issues of safety or effectiveness compared to predicate devices. | "do not present any new issues of safety or effectiveness." |
| Biomechanical Integrity | Must be capable of restoring biomechanical integrity. (Implied from indications for use and mechanical testing). | "The ESL Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column..." |
| Mechanical Performance | Must be substantially equivalent for its intended use to other spacers on the market. | "Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) submission, as it relates to a physical implant and not an AI/ML algorithm requiring a test set of data. The "test set" would primarily refer to the physical devices undergoing mechanical testing, but no numerical sample size for these tests is provided in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable. "Ground truth" in the context of AI/ML refers to objective labels for input data (e.g., expert annotations on images). For a physical medical device like the ESL® Spinal System, there isn't a "ground truth" established by experts in this manner. The evaluation relies on engineering principles, material science, and mechanical testing standards.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or evaluations of AI/ML algorithms where multiple readers assess the same data and resolve discrepancies.
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. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance for diagnostic tasks. The ESL® Spinal System is a surgical implant, not a diagnostic AI tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The ESL® Spinal System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically defined for AI/ML performance is not applicable here. The "truth" for this device's acceptance is established through:
- Compliance with predicate device characteristics: The device's material, design, and indications must align with devices already cleared by the FDA.
- Mechanical testing standards: Performance under various load conditions to ensure structural integrity and durability. These are engineering-based "truths" rather than expert consensus on images or pathology results.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of a physical medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As there is no training set, there is no ground truth established for it.
§ 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.