(304 days)
The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
The Sintea Biotech's SPIDER™ expandable tamp is designed to compress cancellous bone as it expands. The SPIDER™ consist of a controlled expanding tamp at the distal end, a cannulated gauge, an awl, guided wires, and a reamer. The product has the same intended use as the predicate. The expandable tamp is made out of biocompatible Nitinol metal.
The provided text is a 510(k) summary for the Sintea Biotech Spider Spinal System. It does not describe a study that proves the device meets acceptance criteria, nor does it provide a table of acceptance criteria and reported device performance. The document focuses on regulatory submission for market clearance rather than detailed performance study results against specific criteria.
Therefore, most of the requested information cannot be extracted from this document because it outlines a regulatory submission rather than a clinical or performance study.
Here's what can be gathered based on the available text:
General Information from the Document:
- Device Name: SPIDER™ Spinal System
- Intended Use: To be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
Given that the document does not contain a detailed study proving the device meets acceptance criteria, the following points will be answered based on the absence of information in the provided text.
Acceptance Criteria and Device Performance:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Information not provided. The document states "There is no set standard of testing for this type of device."
- Reported Device Performance: Information not explicitly detailed in quantifiable acceptance criteria format. The document generically states that "Sintea Biotech has performed mechanical tests to verify the device meets the functional and performance specifications it was designed for. Please see section 18 of this 510(k) submission for detailed test and results." However, Section 18 is not included in the provided text.
Study Details (Based on absence of information):
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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 as no performance study details are provided in this summary. The document mentions "mechanical tests" but does not detail their methodology, sample size, or data provenance.
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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. No ground truth for a test set is discussed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication is discussed.
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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 surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for a study is discussed. The "performance data" mentioned refers to mechanical tests validating engineering specifications, not clinical outcomes or diagnostic accuracy against a ground truth.
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The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
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How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.