(154 days)
The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.
The Transcorp Spinal Access System is an instrument system used for minimally invasive visualization and access to the anterior spine. The system includes the following components:
- Left and right orientation guides with 5°-15° of angulation
- Fixation pins, 12-16mm
- Drills, 2-6mm Diameter x 10-18mm Depth
- Cannulated Drills, 2-6mm Diameter x 10-18mm Depth
- Guide Pin Adapter
- Guide Pins
- Quick Disconnect Handle
- Fixation Pin Driver
- Tamp
- Mallet
The provided document describes a 510(k) premarket notification for the "Transcorp Spinal Access System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The review process for 510(k) devices focuses on demonstrating substantial equivalence, rather than establishing de novo safety and effectiveness through extensive clinical trials.
Therefore, the information for acceptance criteria and a study proving the device meets those criteria will be framed within the context of a 510(k) submission and the concept of "substantial equivalence."
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Similar Technological Characteristics: Device should have similar design, materials, and intended function to the predicate device. | The Transcorp Spinal Access System shares the same technological characteristics, including the types of instruments included, the material (stainless steel), and the function as the predicate system (TranS1 Trans-Sacral Spinal Access and Preparation K032891). It includes components like orientation guides, fixation pins, drills, guide pins, and handles, similar to what would be expected for a spinal access system. |
| Similar Intended Use: Device should have the same intended purpose as the predicate device. | The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone. This is consistent with the general function of spinal access systems, implying a similar intended use to its predicate. |
| Non-Clinical Performance: Device should perform at least as safely and effectively as the legally marketed predicate device, as demonstrated through non-clinical testing. | "Cadaver performance testing, functional testing, and comparison to the predicate demonstrated that the Transcorp Spinal Access System can be used in accordance with the Indications for Use." The conclusion states: "Nonclinical tests demonstrate that the Transcorp Spinal Access System is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device." |
| Safety and Effectiveness (comparative): The device is as safe and effective as the predicate. | The FDA letter confirms: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core finding of a 510(k) process – that the device meets the substantial equivalence standard. |
Regarding the Study (or evidence) that proves the device meets the acceptance criteria:
The primary "study" described is a Non-Clinical Testing Summary, which included:
- Cadaver performance testing: This type of testing would assess the device's ability to be used successfully in a simulated surgical environment (on cadavers) for its intended purpose (minimally invasive access to the anterior spine).
- Functional testing: This likely involved benchtop tests to evaluate the physical and mechanical properties of the instruments (e.g., strength of drills, accuracy of guides, durability of materials).
- Comparison to the predicate: This involved direct comparison of the Transcorp system's features, materials, and performance against the legally marketed predicate device (TranS1 Trans-Sacral Spinal Access and Preparation K032891) to demonstrate similarity and equivalent performance.
The conclusion drawn from this non-clinical testing was that the Transcorp Spinal Access System is "as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device." This finding enables the FDA to determine that the new device is "substantially equivalent" to an already marketed device, which is the "acceptance criteria" for a 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document explicitly mentions "Cadaver performance testing." While it confirms cadavers were used, it does not specify the number of cadavers used for the performance testing.
- Data Provenance: Not specified, but generally, cadaver studies for medical device testing are conducted in controlled laboratory environments. The country of origin for the data is not mentioned. The description of testing indicates a prospective assessment of the device.
3. 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)
- The document does not specify the number or qualifications of experts involved in establishing any "ground truth" for the non-clinical tests. For cadaver and functional testing, it's typically engineers, surgeons, or anatomists who evaluate performance, but their specific involvement and qualifications are not detailed. In the context of a 510(k), the "ground truth" is largely the performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not mention any adjudication method as it relates to expert review or consensus for the non-clinical tests. Such methods are typically relevant for clinical studies or image interpretation tasks, which are not detailed here.
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
- No MRMC comparative effectiveness study was done. This type of study (MRMC) is generally performed for diagnostic imaging devices involving human interpretation, often when Artificial Intelligence (AI) is involved to assess its impact on reader performance. The Transcorp Spinal Access System is an instrument system, not a diagnostic imaging device with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Transcorp Spinal Access System is a set of surgical instruments, not an algorithm or software-only device. Therefore, a standalone performance assessment in the context of "algorithm only" is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device and submission, the "ground truth" is effectively:
- Functional performance standards: Whether the instruments perform their intended mechanical actions (e.g., drills cut, guides guide).
- Cadaveric anatomical access: Whether the system allows appropriate visualization and access to the anterior spine in cadaver models.
- Comparison to predicate: The established safe and effective performance of the legally marketed predicate device upon which substantial equivalence is based.
8. The sample size for the training set
- Since the submission is based on non-clinical testing and comparison to a predicate, and there is no mention of an algorithm or machine learning component, there is no "training set" in the conventional sense (e.g., for AI model development).
9. How the ground truth for the training set was established
- As there is no training set for an algorithm, this question is not applicable.
§ 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.