(34 days)
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated.
Instrumed Retractors (frame, arm, blades, tubes) provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement and positioning of the retractor posterior, anterior cervical and down to the laminalspine, with its attachment to a rigid frame or a flexible arm to provide a self locking method of access to the spinal site through which a endoscope and/or surgical instruments can be manipulated.
The provided document, K071771, is a 510(k) Pre-Market Notification Summary for the Instrumed Retractors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with acceptance criteria for device performance as would be expected for novel devices or higher-risk classifications.
Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication methods, and ground truth establishment is not present in this document because it is not typically required nor performed for a 510(k) submission of this nature.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no quantitative table of acceptance criteria or specific device performance reported in a measurable way (e.g., accuracy, sensitivity, specificity, mechanical durability numbers). The 510(k) submission for the Instrumed Retractors relies on demonstrating "substantial equivalence" to predicate devices, meaning it performs similarly and is as safe and effective.
The summary states:
"The presented data that was conducted on the Instrumed Retractors shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness."
This is a general statement of equivalency rather than specific, quantified performance against predefined acceptance criteria. Testing likely involved mechanical testing to ensure the device performs its intended function (e.g., maintaining position, retracting tissue) and material safety, but specific performance metrics are not listed.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical "test set" in the context of a prospective study to evaluate new performance metrics. The claim is based on comparison to predicate devices and the fact that "All models that are covered by this 510(k) premarket notification have been on the market (international) for many years with no device failures." This implies real-world usage data, but a formal "test set" with a defined sample size as for a new performance study is not discussed.
- Data Provenance: The statement "have been on the market (international) for many years with no device failures" suggests the data provenance is historical, real-world usage from established markets, likely outside the US initially, given the international mention. This is retrospective observational data rather than a controlled prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment by experts for a specific test set is described, as the submission relies on substantial equivalence and historical performance rather than a new clinical performance study requiring such an assessment.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is not mentioned or implied. The device is a surgical retractor, not an imaging or diagnostic device that would typically involve a multi-reader study. The comparison is between the new device and predicate devices based on design, materials, and intended use, not human reader performance with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:
Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable in the conventional sense of establishing a medical diagnosis. The "ground truth" here is implied to be the proven safety and effectiveness of the predicate devices over time, coupled with the assertion that the new device shares similar characteristics and has also performed reliably ("no device failures") in prior (international) market use. The safety of the materials is also a "ground truth" established through prior research and use.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set, as this is not an AI/algorithm-driven device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this type of device submission.
In summary, for K071771, the "study" that proves the device meets (implied) acceptance criteria is a demonstration of substantial equivalence to predicate devices and the historical safety record of the Instrumed Retractors in international markets. This is a common pathway for Class II medical devices that are similar to existing ones, and it does not involve the detailed clinical trial and performance metric reporting often associated with novel medical technologies or higher-risk devices.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).