(88 days)
(Constitution™ PLIF. Continental TM ALIF. PATRIOT™ Spacers TransContinental™ LLIF and Signature™ TLIF Spacers) are interbody fusion devices 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
The PATRIOT™ Spacers (Constitution™ PLIF, Signature™ TLIF . Continental™ ALIF, and TransContinental™ LLIF Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. Each of the PATRIOT™ Spacers provides a different shape to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal, anterior). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT™ Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
The provided text does not contain information about acceptance criteria or a study proving device performance in the sense of clinical effectiveness or diagnostic accuracy for the PATRIOT™ Spacers.
Instead, the document is a 510(k) summary and an FDA clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving performance based on specific statistical acceptance criteria from a clinical trial.
Here's a breakdown of what the document does state in relation to your questions, and what it does not provide:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for clinical outcomes or diagnostic accuracy. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence under the "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.
- Reported Device Performance: The document states, "PATRIOT™ Spacers have been evaluated in accordance with the 'Class II Special Controls Guidance Document: Intervertebral Fusion Device', June 12, 2007 and have been found to meet the criteria set forth in the guidance document in terms of indications, design, and performance." This broadly indicates compliance with regulatory expectations for safety and effectiveness, but does not provide specific performance data (e.g., fusion rates, complication rates, improvements in patient-reported outcomes) that would be derived from a clinical study with predefined acceptance criteria. This is typical for 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through other means (e.g., design, materials, intended use, non-clinical testing).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical "test set" or patient data from human trials are mentioned for establishing device performance. The evaluation was done against guidance documents.
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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, as no clinical test set or ground truth determination by experts for performance evaluation is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the same reason as above.
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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 not an AI/diagnostic imaging device, an MRMC study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical intervertebral fusion device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the context of clinical performance evaluation is mentioned. The "ground truth" for this submission is adherence to the "Class II Special Controls Guidance Document" and demonstrating substantial equivalence to the predicate device (BAK Interbody Fusion System P95002).
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The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of machine learning or an algorithm for this physical device.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
In summary: The provided document is a regulatory submission demonstrating the device's substantial equivalence to a predicate device based on regulatory guidance and design principles, not a study presenting clinical effectiveness data with specific acceptance criteria and a test set. Therefore, most of your requested information regarding performance studies, sample sizes, and ground truth is not present in this document.
§ 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.