(288 days)
The Longbow Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Longbow Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone and titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Longbow Spacer System components from any other system or manufacturer. The Longbow Spacer System components should never be reused under any circumstances.
The provided text describes a medical device, the Longbow Spacer System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance studies, nor does it detail a study proving the device meets specific acceptance criteria in the way described by your request.
Instead, this document (a 510(k) summary and FDA letter) focuses on demonstrating substantial equivalence to already approved devices rather than conducting a de novo performance study against pre-defined acceptance criteria.
Here's why the requested information cannot be fully provided from the given text:
- Acceptance Criteria and Reported Performance: The document doesn't list specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or specific biomechanical thresholds that must be met by a certain percentage) or report device performance against them.
- Sample Size, Ground Truth, Adjudication, MRMC Study, Standalone Performance, Training Set: These are concepts typically associated with performance studies of AI/ML or diagnostic devices where observational data is analyzed and compared against a ground truth. The Longbow Spacer System is an intervertebral body fusion device, which is a physical implant. The "performance data" mentioned refers to biomechanical testing, not clinical or diagnostic performance in the requested sense.
However, based on the biomechanical testing mentioned, we can infer a simplified "acceptance criteria" and the type of "study" performed:
Inferred Acceptance Criteria and Study for the Longbow Spacer System (based on biomechanical testing):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device must meet or exceed the static and dynamic compression and compressive shear requirements of ASTM F2077 for intervertebral body fusion devices. | "Static and dynamic compression and compressive shear testing according to ASTM F2077 was presented in conjunction with engineering analysis to demonstrate the substantial equivalency of the Longbow Spacer System." |
While specific numerical results are not provided in this summary, the statement implies that the device successfully met the requirements of this standard, thus demonstrating performance comparable to predicate devices. |
Further Breakdown of Requested Information (where applicable or inferable):
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A table of acceptance criteria and the reported device performance: See above. The acceptance criteria are "meeting ASTM F2077 standards," and the reported performance is that the device did meet these standards.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the biomechanical testing. Biomechanical tests typically involve a relevant number of device samples (e.g., 3-6) for each test condition, although exact numbers are not in this summary.
- Data Provenance: Not applicable in the sense of clinical data origin. The testing is laboratory-based biomechanical testing of the physical device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biomechanical testing is typically defined by engineering standards and measurement accuracy, not expert consensus on observations.
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Adjudication method for the test set: Not applicable.
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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 device is a physical implant, not a diagnostic or AI-assisted tool requiring human reader comparison.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For biomechanical testing, the "ground truth" would be the engineering specifications and performance thresholds defined by the ASTM F2077 standard, measured by calibrated testing equipment.
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The sample size for the training set: Not applicable. This refers to AI/ML context.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical implant, not a performance study for a diagnostic or AI-driven device. Therefore, many of your questions, which are highly relevant to AI/ML or diagnostic performance studies, do not apply to the context of this document. The "study" mentioned is biomechanical testing to demonstrate the physical integrity and performance of the implant according to established engineering standards (ASTM F2077).
§ 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.