(136 days)
The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
The FORZA® PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.
The FORZA® PTC Spacer System is comprised of a variety of implants that have a PEEK core as described by ASTM F-2026 with two integrated porous Titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.
The FORZA® PTC Spacer System is not intended to be used as a standalone device. The FORZA® PTC Spacer System must be used with a supplemental fixation system. The FORZA® PTC Spacer System implants are provided sterile.
The provided text describes a 510(k) premarket notification for a medical device called the FORZA® PTC Spacer System. This submission aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
However, the document focuses on non-clinical performance data (mechanical and material testing) to establish substantial equivalence for a medical implant, not on a study proving a device meets acceptance criteria in the context of an AI/software device that needs performance metrics like accuracy, sensitivity, or specificity.
Therefore, based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving device performance in the manner requested.
The questions you've asked (about sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically relevant for evaluating the performance of AI/Machine Learning-based medical devices or diagnostic tools. The document describes a traditional medical device (an intervertebral body fusion device) and its premarket submission process, which relies on demonstrating mechanical, material, and design equivalence to previously approved devices, rather than clinical performance metrics from a human-in-the-loop or standalone AI study.
To directly address your request, I will state that the information is not present in the provided text.
Here's an explanation of why each point cannot be answered:
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A table of acceptance criteria and the reported device performance: The document reports mechanical test results (Static and Dynamic Axial Compression, Static and Dynamic Compression Shear, Static Torsion, Subsidence, Expulsion, Taber abrasion, tensile testing, coating shear strength, wear test). It states that these results "demonstrated that FORZA® PTC Spacer System is substantially equivalent to the predicate FORZA Spacer System K103111." However, specific numerical acceptance criteria (e.g., "must achieve > X% compression strength") and the exact numerical performance values are not provided, nor are they presented in a table. The primary acceptance criterion here seems to be "substantially equivalent" to predicates based on these tests.
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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): Not applicable or not provided. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset of patient information. The number of physical units tested is not specified, nor is "data provenance" in the sense of patient data.
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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. "Ground truth" in this context would refer to material properties or mechanical performance, which are established through standardized ASTM tests, not expert consensus on patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of patient data, which is not what this document describes.
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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 an implant, not an AI diagnostic tool that would be evaluated with an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the mechanical performance is the established standards and specifications for material properties and mechanical strength as defined by ASTM standards (e.g., ASTM F2077-11, ASTM F2267-04, ASTM F1978, ASTM F1147, ASTM F1044, ASTM F1877).
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The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of medical device's performance evaluation.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the document provides information about a regulatory submission for a physical medical device (intervertebral spacer) and its evaluation through non-clinical, mechanical, and material testing to demonstrate substantial equivalence. It does not contain the type of clinical or AI performance study data that your questions are designed to ascertain.
§ 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.